CAL-C: A Concierge Model of CAE Plus LAI in Individuals With Schizophrenia at Risk for Treatment Non-adherence and Homelessness

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02085447
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 31
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This is a prospective study using a concierge model of customized adherence enhancement and long-acting injectable antipsychotic (CAL-Concierge) in 30 individuals with schizophrenia or schizoaffective disorder at risk for treatment non-adherence and for homelessness. Like the CAE-L approach, CAL-Concierge is expected to improve health outcomes among the most vulnerable of populations with schizophrenia but even more importantly, will demonstrate that it can be used to improve the efficiency and quality of care in typical practice settings.

Condition or Disease	Intervention/Treatment	Phase
Psychotic Disorders; Schizophrenia; Schizoaffective Disorder; Medication Adherence; Medication Non-Adherence	Behavioral: CAE-L	N/A

Detailed Description

Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia, but rates of full or partial non-adherence exceed 60%. There is direct correlation between non-adherence and rates of relapse in schizophrenia; on average, non-adherent patients have a risk of relapse that is 3.7 times greater than their adherent counterparts. Long-acting injectable antipsychotic (LAI) medication can improve adherence but needs to be combined with a quality behavioral program to modify long-term attitudes and behaviors.

A recently completed study funded by the Reuter Foundation and conducted by these investigators found that a novel customized psychosocial adherence enhancement intervention paired with LAI (CAE-L) reduced rates of homelessness, improved psychiatric symptoms and increased overall functioning in this very vulnerable group of individuals. CAE has been manualized and appears very acceptable to homeless people with serious mental illness. However, in spite of the very promising results, the CAE-L intervention has some important limitations that are barriers to its wide-spread future use in public health settings. These limitations are:

1. CAE-L used a PhD-level psychologist to deliver the behavioral part of the program. Many public-sector clinical settings have a very limited number of such highly trained individuals. As an alternative, social workers could be an efficient way to deliver CAE.

2. CAE-L used only haloperidol decanoate as the injectable medication. Unfortunately, akathisia-- a very distressing side effect, occurred in 40% of people. Use of a newer, better tolerated medication option could improve the investigators approach.

3. Logistic barriers preventing people who were stabilized and doing well on CAE-L to continue their improved functioning once they transitioned back to regular care settings. It is clear that there needs to be a mechanism to facilitate the successful "hand-off" of individuals who have benefitted from CAE-L into maintenance therapy. A successful transition could have substantial financial and humanitarian cost-savings.

To address these obstacles and in preparation for a large-scale randomized controlled trial of this novel, blended intervention the investigators propose to conduct a prospective study using a concierge model of customized adherence enhancement combined with a long-acting injectable antipsychotic (CAL-Concierge) in individuals with schizophrenia at risk for treatment non-adherence and for homelessness. Like the CAE-L approach, CAL-Concierge is expected to improve health outcomes among the most vulnerable of populations with schizophrenia but even more importantly, will demonstrate that it can be used to improve the efficiency and quality of care in typical practice settings.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Concierge Model of Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (CAL-C) in Individuals With Schizophrenia at Risk for Treatment Non-adherence and for Homelessness
• Actual Study Start Date: May 1, 2014
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: CAE-L Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.

Behavioral: CAE-L; Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.; Other Names: CAE Customized Adherence Enhancement LAI Long Acting Injectable Antipsychotic Haldol Decanoate haloperidol decanoate Invega Sustenna paliperidone palmitate

Outcome Measures

Primary Outcome Measures

1. Change in Tablets Routine Questionnaire (TRQ, Past Week) From Screen to Week 25 Visit [Screen, Week 25]

   The Tablets Routine Questionnaire (TRQ) determines the proportion of prescribed medication taken and is not dependent upon timing of medication provided that medication is consumed within the required day/24 hour period. This rating has demonstrated statistically significant association with past non-adherence, repeated past non-adherence, any non-adherence in the past month, and non-adherence in the past week. The TRQ format will be modified slightly to document all adherence values (an exact proportion) for each item. TRQ scores ranges from perfect adherence (0% missed) to missing all medication (100% missed). An average TRQ was calculated for individuals on more than one BD medication.

2. Change in Tablets Routine Questionnaire (TRQ) (Past Month) From Screen to Week 25 [Screen, Week 25]

   The Tablets Routine Questionnaire (TRQ) determines the proportion of prescribed medication taken and is not dependent upon timing of medication provided that medication is consumed within the required day/24 hour period. This rating has demonstrated statistically significant association with past non-adherence, repeated past non-adherence, any non-adherence in the past month, and non-adherence in the past week. The TRQ format will be modified slightly to document all adherence values (an exact proportion) for each item. TRQ scores ranges from perfect adherence (0% missed) to missing all medication (100% missed). An average TRQ was calculated for individuals on more than one BD medication.

3. Long-acting Injection (LAI) Adherence [Week 25]

   Long-acting injection (LAI) adherence will be determined as a proportion of LAI (paliperidone palmitate or haloperidol decanoate) injections received at the appropriate time (within 7 days of scheduled time).

Secondary Outcome Measures

1. Change in DAI (Drug Attitudes Index) From Screen to Week 25 [Screen, Week 25]

   The DAI contains ten true-false items. Correct responses are scored as +1, while incorrect responses are scored as 0. The highest possible score is 10, while the lowest possible score is 0. Higher scores indicate better drug attitudes, while lower scores indicate worse drug attitudes.

2. Change in AMSQ (Attitudes Toward Mood Stabilizers Questionnaire) From Screen to Week 25 [Screen, Week 25]

   The AMSQ/AMQ is used to measure attitudes towards medications. The scale contains 19 items. Responses which suggest positive attitudes towards medications are scored "0", while responses which suggest negative attitudes towards medications are scored "1". The items scores are added for a total score. Total scores range from 0 to 19. Lower total scores suggest more positive attitudes, while higher scores suggest more negative attitudes.

3. Change in PANSS (Positive and Negative Syndrome Scale; Positive Symptoms Scale) From Screen to Week 25 [Screen, Week 25]

   The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The Positive Symptoms Subscale consists of 7 questions. Each item is rated on a scale of 1 (Absent) to 7 (Extreme). Total scores for the Positive Symptoms Subscale range from 7-49. Higher scores indicate more symptoms of psychopathology. There is no aggregate score for this measure, as the subscales are to be scored separately.

4. Change in PANSS (Positive and Negative Syndrome Scale; Negative Symptoms Scale) From Screen to Week 25 [Screen, Week 25]

   The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The Negative Symptoms Subscale consists of 7 questions. Each item is rated on a scale of 1 (Absent) to 7 (Extreme). Total scores for the Negative Symptoms Subscale range from 7-49. Higher scores indicate more symptoms of psychopathology. There is no aggregate score for this measure, as the subscales are to be scored separately.

5. Change in PANSS (Positive and Negative Syndrome Scale; Composite Scale) From Screen to Week 25 [Screen, Week 25]

   The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The Composite Scale is scored by subtracting the negative score from the positive score. This yields a bipolar index that ranges from -42 to +42. The bipolar composite scale simply expresses the direction and magnitude of difference between positive and negative syndromes. Scores >0 indicate there are more positive symptoms of schizophrenia endorsed, and scores <0 indicate there are more negative symptoms of schizophrenia endorsed. There is no aggregate score for this measure, as the subscales are to be scored separately.

6. Change in PANSS (Positive and Negative Syndrome Scale; General Psychopathology) From Screen to Week 25 [Screen, Week 25]

   The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The General Psychopathology Subscale consists of 16 questions. Each item is rated on a scale of 1 (Absent) to 7 (Extreme). Total scores range from 16-112 on the General Psychopathology scale. Higher scores indicate more symptoms of psychopathology. There is no aggregate score for this measure, as the subscales are to be scored separately.

7. Change in CGI (Clinical Global Impression) From Screen to Week 25 [Screen, Week 25]

   The CGI evaluates global psychopathology illness severity on a 7 point Likert Scale (minimum score = 1; maximum score = 7) with higher scores indicating worse pathology.

8. Change in ASSIST GRS (Alcohol, Smoking and Substance Involvement Screening Test ) From Screen to Week 25 [Screen, Week 25]

   The ASSIST was used to measure drug use. A total score is derived by combining item scores (minimum score = 0; maximum score = 382). Higher scores indicate higher risk of lifestyle problems, including health.

9. Change in SOFAS (Social and Occupational Functioning Assessment Scale) From Screen to Week 25 [Screen, Week 25]

   Evaluates social and occupational functioning on a scale of 0 (Inadequate information) to 100 (Superior functioning). It is a one-item measure.

10. Change in AIMS (Abnormal Involuntary Movement Scale) From Baseline to Week 25 [Baseline, Week 25]

    The AIMS is used to monitor for the development of involuntary movements that may occur as a result of certain psychotropic medication. It contains 14 items, 10 of which are rated on a scale of 0 (None) to 4 (Severe). The remaining four items are "yes or no" questions. Items 1 thru 7 are added for a total score, while item 8 is used as an overall severity index. Total scores range from 0 to 28. Higher scores indicate more adverse outcomes.Items 9 thru 12 provide additional information that may be useful in determining lip, jaw, and tongue movements.

11. Change in SAS (Simpson Angus Scale) From Screen to Week 25 [Screen, Week 25]

    The Simpson-Angus Scale is used to monitor for neurological and musculoskeletal side effects that may be a result of certain psychotropic medications. The scale consists of 10 questions which each can be rated on a scale of 0 to 4. Scores for each item are added to produce a total score. Total scores range from 0 to 40. Higher scores indicate more adverse outcomes.

12. Change in BARS (Barnes Akathisia Rating Scale) From Screen to Week 25 [Screen, Week 25]

    This scale is used to measure the presence of akathisia, as may result from use of certain psychotropic medications. The scale contains four items and the score for each item is added to produce the total score. Total scores range from 0 to 14. Higher scores indicate more adverse outcomes.

13. Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Parkinsonism) From Screen to Week 25 [Screen, Week 25]

    For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. The score for Parkinsonism (including akathisia), ranges from 0 to 102 (17 items), and is based on all items of the Parkinsonism examination: tremor (0-48), gait and posture (0-6), postural stability (0-6), rigidity (0-24), expressive automatic movements (0-6), bradykinesia (0-6), akathisia (0-6). Higher scores indicate more severity.

14. Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dystonia) From Screen to Week 25 [Screen, Week 25]

    For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. The score for dystonia ranges from 0 to 60 (10 items), and is formed by including both acute and chronic dystonia, based on the dystonia examination. Higher scores indicate more severity.

15. Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dyskinesia) From Screen to Week 25 [Screen, Week 25]

    For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. Score for TD, ranging from 0 to 42, is based on the sum of all seven items in the TD objective examination. Higher scores indicate more severe symptomology.

16. Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Akathisia) [Screen, Week 25]

    For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. The score for akathisia is separated from the Parkinsonism score and is based on the combined score of subjective akathisia (item 6 of the questionnaire) and objective akathisia (item 7 of the Parkinsonism/Akathisia objective examination). This subscore total ranges from 0 to 6. Higher scores indicate more severity.

17. Change in Hospitalizations (Psychiatric) in the Past 6 Months From Screen and Week 25 [Screen, Week 25]

    Change in number of psychiatric hospitalizations from the past 6 months from Screen and Week 25. This is calculated by subtracting the number of psychiatric hospitalizations at screen from the number of psychiatric hospitalizations at week 25.

18. Change in Hospitalizations (Medical) in the Past 6 Months From Screen and Week 25 [Screen, Week 25]

    Change in number of psychiatric hospitalizations from the past 6 months from Screen and Week 25. This is calculated by subtracting the number of psychiatric hospitalizations at screen from the number of psychiatric hospitalizations at week 25.

19. Percentage Change of Days of Sub-optimal Housing in the Past Six Months; Change From Screen to Week 25 [Screen, Week 25]

    Change in number of sub-optimal housing from the past 6 months from Screen and Week 25. This is calculated by subtracting the percent of sub-optimal housing at screen from the number of sub-optimal housing at week 25.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Individuals age 18 and older with schizophrenia or schizoaffective disorder as confirmed by the Mini International Psychiatric Inventory (MINI). The investigators will use a DSM-5 concordant version of the MINI if it is available at the time that the first study participant is enrolled.

• Individuals who are currently or have been recently homeless (within the past 12 months) as per revised federal definition of homelessness (Homeless Emergency Assistance and Rapid Transition to Housing. In: Development DoHaU, ed2011.)

• Known to have medication treatment adherence problems as identified by the Treatment Routines Questionnaire (TRQ, 20% or more missed medications in past week or past month)

• Ability to be rated on psychiatric rating scales.

• Willingness to take long-acting injectable medication

• Currently in treatment at a Community Mental Health Clinic (CMHC) or other treatment setting able to provide mental health care during and after study participation

• Able to provide written, informed consent to study participation.

Exclusion Criteria:

• Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment.

• Prior or current treatment with clozapine

• Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial

• Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist

• Immediate risk of harm to self or others

• Female who is currently pregnant or breastfeeding

• Individual who is already in permanent and supported housing that includes comprehensive mental health services (i.e. Housing First)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center

Investigators

• Principal Investigator: Martha Sajatovic, MD, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Martha Sajatovic, Professor of Psychiatry, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT02085447
• Other Study ID Numbers: R092670SCH4031
• First Posted: Mar 12, 2014
• Last Update Posted: Dec 9, 2019
• Last Verified: Dec 1, 2019

• Keywords provided by Martha Sajatovic, Professor of Psychiatry, University Hospitals Cleveland Medical Center: Homelessness; Antipsychotic Drugs; Antipsychotics; Injectables; Long Acting Injectable Antipsychotic; Psychotic Disorders; Schizophrenia; Schizoaffective Disorder; Medication Adherence; Medication Non-Adherence; Community Mental Health Centers
• Additional relevant MeSH terms: Disease; Schizophrenia; Mental Disorders; Psychotic Disorders; Haloperidol; Paliperidone Palmitate; Haloperidol decanoate; Antipsychotic Agents

Study Results

Participant Flow

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Period Title: Overall Study
STARTED	30
COMPLETED	26
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.6 (9.5)
Sex: Female, Male (Count of Participants)
Female	12 40%
Male	18 60%
Race/Ethnicity, Customized (Count of Participants)
Hispanic ethnicity	2 6.7%
Caucasian	3 10%
African American	26 86.7%
Region of Enrollment (participants) [Number]
United States	30 100%
Marital Status, categorical (Count of Participants)
Single, never married	21 70%
Divorced	7 23.3%
Widowed	1 3.3%
Missing data	1 3.3%
Type of Illness, categorical (Count of Participants)
Schizophrenia	6 20%
Schizoaffective disorder	24 80%
Age of SMI (serious mental illness) onset, continuous (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.3 (19.4)
TRQ (Tablets Routine Questionnaire) Mean, SD (percentage of adherence) [Mean (Standard Deviation) ]
Past Week	46.5 (35.6)
Past Month	43.3 (32.9)
Housing status as a percentage of the previous 180 days (%, SD) (percentage of days) [Mean (Standard Deviation) ]
Outdoors	6.3 (17.0)
Short-term/emergency shelter	13.6 (26.8)
Transitional housing	19.2 (30.4)
Permanent housing with assistance	9.0 (26.9)
Permanent housing without assistance	37.9 (48.2)
Incarceration	5.8 (15.4)
History of substance abuse (N, %) (Count of Participants)
Count of Participants [Participants]	12 40%
History of incarceration in the last 6 months (N, %) (Count of Participants)
Count of Participants [Participants]	9 30%
BMI (mean, SD) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	31.2 (7.6)

Outcome Measures

1. Primary Outcome

Title	Change in Tablets Routine Questionnaire (TRQ, Past Week) From Screen to Week 25 Visit
Description	The Tablets Routine Questionnaire (TRQ) determines the proportion of prescribed medication taken and is not dependent upon timing of medication provided that medication is consumed within the required day/24 hour period. This rating has demonstrated statistically significant association with past non-adherence, repeated past non-adherence, any non-adherence in the past month, and non-adherence in the past week. The TRQ format will be modified slightly to document all adherence values (an exact proportion) for each item. TRQ scores ranges from perfect adherence (0% missed) to missing all medication (100% missed). An average TRQ was calculated for individuals on more than one BD medication.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 TRQ. As such, the change from screen only calculates for those who have both values, or in this case, n=16.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	16
Mean (Standard Deviation) [percentage of adherence]	56.2 (33.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.012
	Comments
	Method	t-test, 1 sided
	Comments

2. Primary Outcome

Title	Change in Tablets Routine Questionnaire (TRQ) (Past Month) From Screen to Week 25
Description	The Tablets Routine Questionnaire (TRQ) determines the proportion of prescribed medication taken and is not dependent upon timing of medication provided that medication is consumed within the required day/24 hour period. This rating has demonstrated statistically significant association with past non-adherence, repeated past non-adherence, any non-adherence in the past month, and non-adherence in the past week. The TRQ format will be modified slightly to document all adherence values (an exact proportion) for each item. TRQ scores ranges from perfect adherence (0% missed) to missing all medication (100% missed). An average TRQ was calculated for individuals on more than one BD medication.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 TRQ. As such, the change from screen only calculates for those who have both values, or in this case, n=15.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L (Customized Adherence Enhancement- Long-acting injectable): Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	15
Mean (Standard Deviation) [percentage of adherence]	15.2 (26.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.028
	Comments
	Method	t-test, 1 sided
	Comments

3. Primary Outcome

Title	Long-acting Injection (LAI) Adherence
Description	Long-acting injection (LAI) adherence will be determined as a proportion of LAI (paliperidone palmitate or haloperidol decanoate) injections received at the appropriate time (within 7 days of scheduled time).
Time Frame	Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants. As such, the number analyzed for LAI adherence is n=16.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	16
Mean (Standard Deviation) [percentage of adherence]	90.5 (30.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.162
	Comments
	Method	t-test, 1 sided
	Comments

4. Secondary Outcome

Title	Change in DAI (Drug Attitudes Index) From Screen to Week 25
Description	The DAI contains ten true-false items. Correct responses are scored as +1, while incorrect responses are scored as 0. The highest possible score is 10, while the lowest possible score is 0. Higher scores indicate better drug attitudes, while lower scores indicate worse drug attitudes.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 DAI. As such, the change from screen only calculates for those who have both values, or in this case, n=23.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	23
Mean (Standard Deviation) [units on a scale]	8.5 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.021
	Comments
	Method	t-test, 1 sided
	Comments

5. Secondary Outcome

Title	Change in AMSQ (Attitudes Toward Mood Stabilizers Questionnaire) From Screen to Week 25
Description	The AMSQ/AMQ is used to measure attitudes towards medications. The scale contains 19 items. Responses which suggest positive attitudes towards medications are scored "0", while responses which suggest negative attitudes towards medications are scored "1". The items scores are added for a total score. Total scores range from 0 to 19. Lower total scores suggest more positive attitudes, while higher scores suggest more negative attitudes.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	26
Mean (Standard Deviation) [units on a scale]	4.0 (2.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.005
	Comments
	Method	t-test, 1 sided
	Comments

6. Secondary Outcome

Title	Change in PANSS (Positive and Negative Syndrome Scale; Positive Symptoms Scale) From Screen to Week 25
Description	The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The Positive Symptoms Subscale consists of 7 questions. Each item is rated on a scale of 1 (Absent) to 7 (Extreme). Total scores for the Positive Symptoms Subscale range from 7-49. Higher scores indicate more symptoms of psychopathology. There is no aggregate score for this measure, as the subscales are to be scored separately.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 PANSS. As such, the change from screen only calculates for those who have both values, or in this case, n=24.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	24
Mean (Standard Deviation) [units on a scale]	21.2 (5.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	t-test, 1 sided
	Comments

7. Secondary Outcome

Title	Change in PANSS (Positive and Negative Syndrome Scale; Negative Symptoms Scale) From Screen to Week 25
Description	The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The Negative Symptoms Subscale consists of 7 questions. Each item is rated on a scale of 1 (Absent) to 7 (Extreme). Total scores for the Negative Symptoms Subscale range from 7-49. Higher scores indicate more symptoms of psychopathology. There is no aggregate score for this measure, as the subscales are to be scored separately.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 PANSS. As such, the change from screen only calculates for those who have both values, or in this case, n=24.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	24
Mean (Standard Deviation) [units on a scale]	12.1 (6.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.197
	Comments
	Method	t-test, 1 sided
	Comments

8. Secondary Outcome

Title	Change in PANSS (Positive and Negative Syndrome Scale; Composite Scale) From Screen to Week 25
Description	The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The Composite Scale is scored by subtracting the negative score from the positive score. This yields a bipolar index that ranges from -42 to +42. The bipolar composite scale simply expresses the direction and magnitude of difference between positive and negative syndromes. Scores >0 indicate there are more positive symptoms of schizophrenia endorsed, and scores <0 indicate there are more negative symptoms of schizophrenia endorsed. There is no aggregate score for this measure, as the subscales are to be scored separately.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 PANSS. As such, the change from screen only calculates for those who have both values, or in this case, n=24.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	24
Mean (Standard Deviation) [units on a scale]	.8 (6.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	t-test, 1 sided
	Comments

9. Secondary Outcome

Title	Change in PANSS (Positive and Negative Syndrome Scale; General Psychopathology) From Screen to Week 25
Description	The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The General Psychopathology Subscale consists of 16 questions. Each item is rated on a scale of 1 (Absent) to 7 (Extreme). Total scores range from 16-112 on the General Psychopathology scale. Higher scores indicate more symptoms of psychopathology. There is no aggregate score for this measure, as the subscales are to be scored separately.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 PANSS. As such, the change from screen only calculates for those who have both values, or in this case, n=22.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	22
Mean (Standard Deviation) [units on a scale]	24.7 (6.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	t-test, 1 sided
	Comments

10. Secondary Outcome

Title	Change in CGI (Clinical Global Impression) From Screen to Week 25
Description	The CGI evaluates global psychopathology illness severity on a 7 point Likert Scale (minimum score = 1; maximum score = 7) with higher scores indicating worse pathology.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 CGI. As such, the change from screen only calculates for those who have both values, or in this case, n=22.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	22
Mean (Standard Deviation) [units on a scale]	2.9 (.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	t-test, 1 sided
	Comments

11. Secondary Outcome

Title	Change in ASSIST GRS (Alcohol, Smoking and Substance Involvement Screening Test ) From Screen to Week 25
Description	The ASSIST was used to measure drug use. A total score is derived by combining item scores (minimum score = 0; maximum score = 382). Higher scores indicate higher risk of lifestyle problems, including health.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 ASSIST. As such, the change from screen only calculates for those who have both values, or in this case, n=20.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	20
Mean (Standard Deviation) [units on a scale]	2.0 (2.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.053
	Comments
	Method	t-test, 1 sided
	Comments

12. Secondary Outcome

Title	Change in SOFAS (Social and Occupational Functioning Assessment Scale) From Screen to Week 25
Description	Evaluates social and occupational functioning on a scale of 0 (Inadequate information) to 100 (Superior functioning). It is a one-item measure.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	26
Mean (Standard Deviation) [units on a scale]	63.1 (8.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	t-test, 1 sided
	Comments

13. Secondary Outcome

Title	Change in AIMS (Abnormal Involuntary Movement Scale) From Baseline to Week 25
Description	The AIMS is used to monitor for the development of involuntary movements that may occur as a result of certain psychotropic medication. It contains 14 items, 10 of which are rated on a scale of 0 (None) to 4 (Severe). The remaining four items are "yes or no" questions. Items 1 thru 7 are added for a total score, while item 8 is used as an overall severity index. Total scores range from 0 to 28. Higher scores indicate more adverse outcomes.Items 9 thru 12 provide additional information that may be useful in determining lip, jaw, and tongue movements.
Time Frame	Baseline, Week 25

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	23
Mean (Standard Deviation) [units on a scale]	1.5 (2.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.821
	Comments
	Method	t-test, 1 sided
	Comments

14. Secondary Outcome

Title	Change in SAS (Simpson Angus Scale) From Screen to Week 25
Description	The Simpson-Angus Scale is used to monitor for neurological and musculoskeletal side effects that may be a result of certain psychotropic medications. The scale consists of 10 questions which each can be rated on a scale of 0 to 4. Scores for each item are added to produce a total score. Total scores range from 0 to 40. Higher scores indicate more adverse outcomes.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 SAS. As such, the change from screen only calculates for those who have both values, or in this case, n=20.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	20
Mean (Standard Deviation) [units on a scale]	0.0 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.330
	Comments
	Method	t-test, 1 sided
	Comments

15. Secondary Outcome

Title	Change in BARS (Barnes Akathisia Rating Scale) From Screen to Week 25
Description	This scale is used to measure the presence of akathisia, as may result from use of certain psychotropic medications. The scale contains four items and the score for each item is added to produce the total score. Total scores range from 0 to 14. Higher scores indicate more adverse outcomes.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 BARS. As such, the change from screen only calculates for those who have both values, or in this case, n=20.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	20
Mean (Standard Deviation) [units on a scale]	.3 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.425
	Comments
	Method	t-test, 1 sided
	Comments

16. Secondary Outcome

Title	Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Parkinsonism) From Screen to Week 25
Description	For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. The score for Parkinsonism (including akathisia), ranges from 0 to 102 (17 items), and is based on all items of the Parkinsonism examination: tremor (0-48), gait and posture (0-6), postural stability (0-6), rigidity (0-24), expressive automatic movements (0-6), bradykinesia (0-6), akathisia (0-6). Higher scores indicate more severity.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 ESRS-A. As such, the change from screen only calculates for those who have both values, or in this case, n=20.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	20
Mean (Standard Deviation) [units on a scale]	0.0 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.577
	Comments
	Method	t-test, 1 sided
	Comments

17. Secondary Outcome

Title	Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dystonia) From Screen to Week 25
Description	For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. The score for dystonia ranges from 0 to 60 (10 items), and is formed by including both acute and chronic dystonia, based on the dystonia examination. Higher scores indicate more severity.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 ESRS-A. As such, the change from screen only calculates for those who have both values, or in this case, n=20.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	20
Mean (Standard Deviation) [units on a scale]	0.0 (0.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.330
	Comments
	Method	t-test, 1 sided
	Comments

18. Secondary Outcome

Title	Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dyskinesia) From Screen to Week 25
Description	For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. Score for TD, ranging from 0 to 42, is based on the sum of all seven items in the TD objective examination. Higher scores indicate more severe symptomology.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 ESRS-A. As such, the change from screen only calculates for those who have both values, or in this case, n=20.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	20
Mean (Standard Deviation) [units on a scale]	1.4 (2.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.706
	Comments
	Method	t-test, 1 sided
	Comments

19. Secondary Outcome

Title	Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Akathisia)
Description	For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. The score for akathisia is separated from the Parkinsonism score and is based on the combined score of subjective akathisia (item 6 of the questionnaire) and objective akathisia (item 7 of the Parkinsonism/Akathisia objective examination). This subscore total ranges from 0 to 6. Higher scores indicate more severity.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 ESRS-A. As such, the change from screen only calculates for those who have both values, or in this case, n=20.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	20
Mean (Standard Deviation) [units on a scale]	.2 (.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.481
	Comments
	Method	t-test, 1 sided
	Comments

20. Secondary Outcome

Title	Change in Hospitalizations (Psychiatric) in the Past 6 Months From Screen and Week 25
Description	Change in number of psychiatric hospitalizations from the past 6 months from Screen and Week 25. This is calculated by subtracting the number of psychiatric hospitalizations at screen from the number of psychiatric hospitalizations at week 25.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	26
Mean (Standard Deviation) [hospital visits]	.2 (.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.020
	Comments
	Method	t-test, 1 sided
	Comments

21. Secondary Outcome

Title	Change in Hospitalizations (Medical) in the Past 6 Months From Screen and Week 25
Description	Change in number of psychiatric hospitalizations from the past 6 months from Screen and Week 25. This is calculated by subtracting the number of psychiatric hospitalizations at screen from the number of psychiatric hospitalizations at week 25.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	26
Mean (Standard Deviation) [hospital visits]	.2 (.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.103
	Comments
	Method	t-test, 1 sided
	Comments

22. Secondary Outcome

Title	Percentage Change of Days of Sub-optimal Housing in the Past Six Months; Change From Screen to Week 25
Description	Change in number of sub-optimal housing from the past 6 months from Screen and Week 25. This is calculated by subtracting the percent of sub-optimal housing at screen from the number of sub-optimal housing at week 25.
Time Frame	Screen, Week 25

Outcome Measure Data

Analysis Population Description

There is missing data for some participants on the week 25 housing status. As such, the change from screen only calculates for those who have both values, or in this case, n=20.

Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
Measure Participants	20
Mean (Standard Deviation) [percentage of days]	29.0 (38.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CAE-L
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.063
	Comments
	Method	t-test, 1 sided
	Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	CAE-L
Arm/Group Description	Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. CAE-L: Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
All Cause Mortality
	CAE-L
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	CAE-L
	Affected / at Risk (%)	# Events
Total	7/30 (23.3%)
Hepatobiliary disorders
acute alcoholic hepatitis	1/30 (3.3%)	1
Infections and infestations
frostbite	1/30 (3.3%)	1
spider bite	1/30 (3.3%)	1
Injury, poisoning and procedural complications
fall	1/30 (3.3%)	1
Musculoskeletal and connective tissue disorders
hernia	1/30 (3.3%)	1
Psychiatric disorders
psychiatric hospitalization due to suicidal ideation	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
COPD exacerbation	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	CAE-L
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.