Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00338806
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 7
• Location: 1
• Arms: 2
• Duration (Months): 68
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study will develop strategies for early detection and prevention of mood disorders and associated impairment in adolescent children of parents with bipolar disorder.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder; Depression	Behavioral: Interpersonal psychotherapy for prevention with adolescents; Behavioral: Educational clinical monitoring	N/A

Detailed Description

Bipolar Disorder (BD) is a serious medical illness that causes drastic shifts in a person's mood, energy, and ability to function. BD symptoms alternate from increased energy, restlessness, and overly good mood to a lasting sad, anxious, or empty mood and feelings of hopelessness or pessimism. Research suggests that children of parents with BD are at risk for developing mood disorders because of predisposing genetic factors and stressful life events, many of which may be related to their parents' unstable clinical state. Adolescent children of parents with BD must deal simultaneously with the difficult task of negotiating their own developmental transitions, as well as living with a parent with BD. It may be possible to detect symptoms of BD or other mood disorders early in adolescence and prevent the disorder from further interfering with someone's life. This study will develop and refine strategies for early detection and primary prevention of mood disorders and associated impairment in adolescent children of parents with BD.

Participants in this single-blind study will be randomly assigned to receive either interpersonal psychotherapy with adolescents (IPT-PA) or a control intervention, educational clinical monitoring (ECM), for 12 weeks. Participants assigned to IPT-PA will attend twelve sessions. The first four sessions will last 90 minutes each, and will include both family psychoeducation and individual psychotherapy with the adolescent. The remaining sessions will be 45 minutes each, and will include only individual psychotherapy with the adolescent. Participants assigned to ECM will each be assigned to a therapist. During the initial two sessions, which will take place over 2 consecutive weeks, the therapist will focus on mood disorder psychoeducation and participants will receive related written educational material. Participants will then meet with their therapists monthly for 30-minute sessions. Symptoms and functioning will be assessed, but no assistance on building interpersonal skills will be provided. A participant may request a second session each month, but if more than two monthly sessions are required, the participant will be referred for therapy. Mood episodes and symptoms, symptom severity, and functioning will be assessed for all participants at Weeks 6 and 12 and Months 6, 12, and 18 post-treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Prevention for Symptomatic Offspring of Bipolar Parents
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interpersonal Psychotherapy-Prevention Participants will receive interpersonal psychotherapy for prevention with adolescents	Behavioral: Interpersonal psychotherapy for prevention with adolescents; Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.; Other Names: IPT-PA
Active Comparator: Educational and Clinical Monitoring Participants will receive educational clinical monitoring	Behavioral: Educational clinical monitoring; Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.; Other Names: ECM

Outcome Measures

Primary Outcome Measures

1. K SADS-Present Version (KSADS-P) [12 weeks]

   A semi-structured interview designed to assess present episode of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

2. K SADS-Present Version (KSADS-P) [6 months]

   A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

3. K SADS-Present Version (KSADS-P) [12 months]

   A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

4. K SADS-Present Version (KSADS-P) [18 months]

   A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

5. Children's Depression Rating Scale-Revised (CDRS-R) [Week 12]

   CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.

6. Children's Depression Rating Scale-Revised (CDRS-R) [6 months]

   CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.

7. Children's Depression Rating Scale-Revised (CDRS-R) [12 months]

   CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.

8. Children's Depression Rating Scale-Revised (CDRS-R) [18 months]

   CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.

9. Children's Global Assessment Scale (C-GAS) [Week 12]

   C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.

10. Children's Global Assessment Scale (C-GAS) [6 months]

    C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.

11. Children's Global Assessment Scale (C-GAS) [12 months]

    C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.

12. Children's Global Assessment Scale (C-GAS) [18 months]

    C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.

13. Young Mania Rating Scale (YMRS) [Week 12]

    An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.

14. Young Mania Rating Scale (YMRS) [6 months]

    An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.

15. Young Mania Rating Scale (YMRS) [12 months]

    An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.

16. Young Mania Rating Scale (YMRS) [18 months]

    An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.

Secondary Outcome Measures

1. Attitudes Toward Treatment Questionnaire [Measured at Week 12]

   A 4 item measure to evaluate attitudes towards: length of treatment, helpfulness of therapist, effects of participating in research, and additional services desired. Each item had 3 response options: 1.positive (or longer treatment) 2.neutral (or length just right) 3. negative (or shorter treatment). Scores are summed with potential range from 4-12. Lower number indicates more positive attitude

2. Emotion Regulation Questionnaire [Measured at Week 12]

   A self report 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal). Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression).

3. Emotion Regulation Questionnaire [6 months]

   A self-report10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal). Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression).

4. Emotion Regulation Questionnaire [12 months and 18 months]

   A self report 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal). Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression).

5. Family Assessment Device [Measured at Week 12]

   The General Functioning scale, that assesses the overall health/pathology of the family, is used for the study. The 12 item scores are averaged to calculate the total score, which ranges from 1-4, with higher scores reflecting worse functioning

6. Family History Screen [Measured at Week 1 (baseline)]

   A clinician-administered instrument to the adolescent' parent, designed to screen for mood, anxiety, and other disorders in parent's first-degree relatives (parents, spouse).

7. Mood Disorder Questionnaire [Week 1]

   A self-report inventory for the participant' parent that screens for history of a manic or hypomanic syndrome by including 13 yes/no items. A score >7 indicate possible history of mania/hypomania (coded as 1), <7 indicates potential absence of mania/hypomania (coded as 0)

8. Patient Health Questionnaire [Measured at Week 1]

   The PHQ-9 is a depression screen, administered to the adolescents parents in this study. The PHQ-9 scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Scores can range from 0-27, with higher score indicating higher depression levels.

9. Social Adjustment Scale - Self Report for Adolescents [Measured at Week 12]

   (SAS-SR) for adolescents, a self-report instrument with 23 questions that fall into 4 major categories: school, friends, family, and dating. Patients rate themselves for the past 2 weeks and they can receive either a total score or a domain specific score. The total score is used here. Each item is scored 1-5, the total score is the average of the scores on each item, possible range of scores 1-5, higher scores indicating worse functioning.

10. Social Adjustment Scale - Self Report for Adolescents [12 months and 18 months]

    (SAS-SR) for adolescents, a self-report instrument with 23 questions that fall into 4 major categories: school, friends, family, and dating. Patients rate themselves for the past 2 weeks and they can receive either a total score or a domain specific score. The total score is used here. Each item is scored 1-5, the total score is the average of the scores on each item, possible range of scores 1-5, higher scores indicating worse functioning.

11. Social Rhythm Metric Short Form [Measured at Week 12 and Months 6, 12, and 18 post-treatment]

    The Social Rhythm Metric Short Form (SRM-Short Form) measures habitual time at which 5 daily events occur in a person's life over a one-week interval: what time the adolescent gets out of bed, makes first contact with another person, starts school, has dinner, and goes to bed.

12. Treatment Credibility Scale [Measured at Week 1]

    Treatment Credibility Questionnaire. Participant and parent's expectancy about the perceived benefit of treatment will be assessed following the first intervention session after the treatment rationale is given. Adolescents were asked to rate how logical the treatment seemed to them, how confident they were that it would be successful, and how confident they would be in recommending the treatment to a friend. A 0- to 2-point rating scale (0 = none, 1 = some, 2 = a lot) was used (range of possible overall score 0-6, higher score indicating higher treatment credibility)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria for Parents:

• Diagnosis of BD I or II

• Currently in partial or full remission from a depressive or manic episode

• Under active clinical care

Inclusion Criteria for Adolescents:

• Speaks English or Spanish

• Presence of at least one current mood symptom meeting DSM-IV Criterion A and at least one depression or mania symptom meeting DSM-IV Criterion B

• Depression, irritability, anhedonia, or elated mood scored at level 2 or 3 on the KSADS-PL

• Mania symptom scored at level 2 or 3 on the KSADS-PL scale

• Score of less than 40 on the CDRS-R scale

• Score of less than 15 on the YMRS scale

• Mild-moderate functional impairment, defined as a score of greater than 61 and less than 75 on the C-GAS scale

Exclusion Criteria for Parents:

• History of psychosis within 1 month of study entry

• At risk for suicide within 1 month of study entry

Exclusion Criteria for Adolescents:

• Past major depressive or manic episode

• Current or past psychosis

• History of suicide attempts

• Current substance use disorder

• Use of psychotropic medications and other medications that might impact mood (e.g., steroids)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Helen Verdeli, PhD, New York State Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00338806
• Other Study ID Numbers: #5067; K23MH071530
• First Posted: Jun 20, 2006
• Last Update Posted: Aug 15, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by New York State Psychiatric Institute: Prevention; Mood Disorders; Unipolar Depression
• Additional relevant MeSH terms: Depression; Bipolar Disorder; Mood Disorders

Study Results

Participant Flow

Recruitment Details	Recruitment dates:10/06-5/10 Location: New York State Psychiatric Institute (mental health research and patient care)
Pre-assignment Detail	Enrolled subjects were excluded from the trial because they were found to be either too symptomatic or asymptomatic

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Period Title: Acute Phase
STARTED	2	5
COMPLETED	2	4
NOT COMPLETED	0	1
Period Title: Acute Phase
STARTED	2	4
COMPLETED	1	1
NOT COMPLETED	1	3

Baseline Characteristics

Arm/Group Title	IPT- Prevention for Adolescents	Educational and Clinical Monitoring	Total
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.	Total of all reporting groups
Overall Participants	2	5	7
Age (Count of Participants)
<=18 years	2 100%	5 100%	7 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	1 50%	2 40%	3 42.9%
Male	1 50%	3 60%	4 57.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	2 100%	5 100%	7 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%	5 100%	7 100%

Outcome Measures

1. Primary Outcome

Title	K SADS-Present Version (KSADS-P)
Description	A semi-structured interview designed to assess present episode of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	2	4
Participants with sub-syndromal depression	0 0%	2 40%
Participants with sub-syndromal mania	1 50%	0 0%
Participants with current Oppositional defiant dis	1 50%	1 20%
Participants with current Depression	0 0%	1 20%
Participants with current Specific phobia	1 50%	0 0%
Participants with current subsyndromal PTSD	0 0%	1 20%

2. Primary Outcome

Title	K SADS-Present Version (KSADS-P)
Description	A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	1	2
Participants with sub-syndromal depression	0 0%	1 20%
Participants with Specific phobia	1 50%	0 0%
Participant with major depression	0 0%	1 20%

3. Primary Outcome

Title	K SADS-Present Version (KSADS-P)
Description	A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

At the 12 month follow up timepoint only 1 participant was available and willing to be assessed.

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	0	1
Participants with sub-syndromal depression	1 50%
Participants with sub-syndromal mania	1 50%

4. Primary Outcome

Title	K SADS-Present Version (KSADS-P)
Description	A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

At the 18 month follow up point only 1 participant was available and willing be assessed.

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	1	0
Participants with sub-syndromal depression	0 0%
Participant with specific phobia	1 50%

5. Primary Outcome

Title	Children's Depression Rating Scale-Revised (CDRS-R)
Description	CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	2	4
Mean (Standard Deviation) [units on a scale]	26.50 (7.78)	28.75 (7.85)

6. Primary Outcome

Title	Children's Depression Rating Scale-Revised (CDRS-R)
Description	CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	1	2
Mean (Standard Deviation) [units on a scale]	26 (0)	29.5 (2.12)

7. Primary Outcome

Title	Children's Depression Rating Scale-Revised (CDRS-R)
Description	CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

At the 12 month time point 1 participant was available /willing to be assessed

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	0	1
Mean (Standard Deviation) [units on a scale]	31 (0)

8. Primary Outcome

Title	Children's Depression Rating Scale-Revised (CDRS-R)
Description	CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

At the 18 month time point 1 participant was available /willing to be assessed

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	1	0
Mean (Standard Deviation) [units on a scale]	25 (0)

9. Primary Outcome

Title	Children's Global Assessment Scale (C-GAS)
Description	C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	2	4
Mean (Standard Deviation) [units on a scale]	76 (1.41)	70 (4.16)

10. Primary Outcome

Title	Children's Global Assessment Scale (C-GAS)
Description	C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	1	2
Mean (Standard Deviation) [units on a scale]	81 (0)	77.5 (3.54)

11. Primary Outcome

Title	Children's Global Assessment Scale (C-GAS)
Description	C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

At the 12 month time point 1 participant was available /willing to be assessed

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	0	1
Mean (Standard Deviation) [units on a scale]	79 (0)

12. Primary Outcome

Title	Children's Global Assessment Scale (C-GAS)
Description	C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

At the 18 month time point 1 participant was available /willing to be assessed

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	1	0
Mean (Standard Deviation) [units on a scale]	79 (0)

13. Primary Outcome

Title	Young Mania Rating Scale (YMRS)
Description	An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	2	4
Mean (Standard Deviation) [units on a scale]	7 (8.49)	4.5 (4.04)

14. Primary Outcome

Title	Young Mania Rating Scale (YMRS)
Description	An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	1	2
Mean (Standard Deviation) [units on a scale]	2 (0)	3.5 (0.71)

15. Primary Outcome

Title	Young Mania Rating Scale (YMRS)
Description	An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

At the 12 month time point 1 participant was available /willing to be assessed

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	0	1
Mean (Standard Deviation) [units on a scale]	6 (0)

16. Primary Outcome

Title	Young Mania Rating Scale (YMRS)
Description	An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

At the 18 month time point 1 participant was available /willing to be assessed

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	1	0
Mean (Standard Deviation) [units on a scale]	3 (0)

17. Secondary Outcome

Title	Attitudes Toward Treatment Questionnaire
Description	A 4 item measure to evaluate attitudes towards: length of treatment, helpfulness of therapist, effects of participating in research, and additional services desired. Each item had 3 response options: 1.positive (or longer treatment) 2.neutral (or length just right) 3. negative (or shorter treatment). Scores are summed with potential range from 4-12. Lower number indicates more positive attitude
Time Frame	Measured at Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	2	4
Mean (Standard Deviation) [units on a scale]	6.50 (2.12)	7.20 (1.48)

18. Secondary Outcome

Title	Emotion Regulation Questionnaire
Description	A self report 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal). Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression).
Time Frame	Measured at Week 12

Outcome Measure Data

Analysis Population Description

Data were not collected for 6 and 12 month time points

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	2	4
Cognitive reappraisal	4.5 (0.42)	4.02 (0.91)
Emotional suppression	3.35 (0.64)	4.62 (1.32)

19. Secondary Outcome

Title	Emotion Regulation Questionnaire
Description	A self-report10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal). Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	1	2
Cognitive reappraisal	4 (0)	3.5 (0.71)
Emotional suppression	3 (0)	4.5 (0.71)

20. Secondary Outcome

Title	Emotion Regulation Questionnaire
Description	A self report 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal). Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression).
Time Frame	12 months and 18 months

Outcome Measure Data

Analysis Population Description

At the 12 and 18 months time point no participant was willing to be assessed on this secondary outcome measure (had limited time for these assessment visits)

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	0	0

21. Secondary Outcome

Title	Family Assessment Device
Description	The General Functioning scale, that assesses the overall health/pathology of the family, is used for the study. The 12 item scores are averaged to calculate the total score, which ranges from 1-4, with higher scores reflecting worse functioning
Time Frame	Measured at Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	2	4
Mean (Standard Deviation) [units on a scale]	2.3 (0.85)	2.7 (0.51)

22. Secondary Outcome

Title	Family History Screen
Description	A clinician-administered instrument to the adolescent' parent, designed to screen for mood, anxiety, and other disorders in parent's first-degree relatives (parents, spouse).
Time Frame	Measured at Week 1 (baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	2	4
Participants w/ parent'srelatives w/mood disorde	2 100%	4 80%
Participants w/ parent's relatives w/ anxiety	2 100%	3 60%
Participants w/ parents relatives w/substance use	1 50%	2 40%

23. Secondary Outcome

Title	Mood Disorder Questionnaire
Description	A self-report inventory for the participant' parent that screens for history of a manic or hypomanic syndrome by including 13 yes/no items. A score >7 indicate possible history of mania/hypomania (coded as 1), <7 indicates potential absence of mania/hypomania (coded as 0)
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

This measure reflects parental mood.expressed as number of participants whose parent with BDI or BDII endorsed > 7(1)

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	2	4
Number [participants]	2 100%	4 80%

24. Secondary Outcome

Title	Patient Health Questionnaire
Description	The PHQ-9 is a depression screen, administered to the adolescents parents in this study. The PHQ-9 scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Scores can range from 0-27, with higher score indicating higher depression levels.
Time Frame	Measured at Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	2	4
Mean (Standard Deviation) [units on a scale]	12 (2.8)	14.5 (3.70)

25. Secondary Outcome

Title	Social Adjustment Scale - Self Report for Adolescents
Description	(SAS-SR) for adolescents, a self-report instrument with 23 questions that fall into 4 major categories: school, friends, family, and dating. Patients rate themselves for the past 2 weeks and they can receive either a total score or a domain specific score. The total score is used here. Each item is scored 1-5, the total score is the average of the scores on each item, possible range of scores 1-5, higher scores indicating worse functioning.
Time Frame	Measured at Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	2	4
Mean (Standard Deviation) [units on a scale]	1.9 (0.42)	2.5 (0.57)

26. Secondary Outcome

Title	Social Adjustment Scale - Self Report for Adolescents
Description	(SAS-SR) for adolescents, a self-report instrument with 23 questions that fall into 4 major categories: school, friends, family, and dating. Patients rate themselves for the past 2 weeks and they can receive either a total score or a domain specific score. The total score is used here. Each item is scored 1-5, the total score is the average of the scores on each item, possible range of scores 1-5, higher scores indicating worse functioning.
Time Frame	12 months and 18 months

Outcome Measure Data

Analysis Population Description

At the 12 and 18 months time point no participant was willing to be assessed on this secondary outcome measure (had limited time for these assessment visits)

Arm/Group Title	Interpersonal Psychotherapy for Prevention	Educational Clinical Monitoring
Arm/Group Description	Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Measure Participants	0	0

27. Secondary Outcome

Title	Social Rhythm Metric Short Form
Description	The Social Rhythm Metric Short Form (SRM-Short Form) measures habitual time at which 5 daily events occur in a person's life over a one-week interval: what time the adolescent gets out of bed, makes first contact with another person, starts school, has dinner, and goes to bed.
Time Frame	Measured at Week 12 and Months 6, 12, and 18 post-treatment

Outcome Measure Data

Analysis Population Description

Participants were not filling out form (it required documentation during the week) and reconstructing it in the meetings with the clinician proved to be too time consuming. Measure was withdrawn from the assessment battery

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	0	0

28. Secondary Outcome

Title	Treatment Credibility Scale
Description	Treatment Credibility Questionnaire. Participant and parent's expectancy about the perceived benefit of treatment will be assessed following the first intervention session after the treatment rationale is given. Adolescents were asked to rate how logical the treatment seemed to them, how confident they were that it would be successful, and how confident they would be in recommending the treatment to a friend. A 0- to 2-point rating scale (0 = none, 1 = some, 2 = a lot) was used (range of possible overall score 0-6, higher score indicating higher treatment credibility)
Time Frame	Measured at Week 1

Outcome Measure Data

Analysis Population Description

An ECM participant did not fill out her form

Arm/Group Title	Interpersonal Psychotherapy-Prevention	Educational and Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
Measure Participants	2	3
Mean (Standard Deviation) [units on a scale]	4 (1.41)	3.75 (0.96)

Adverse Events

Time Frame	21 months
Arm/Group Title	Interpersonal Psychotherapy for Prevention		Educational Clinical Monitoring
Arm/Group Description	Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.		Participants will receive educational clinical monitoring Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.
All Cause Mortality
	Interpersonal Psychotherapy for Prevention		Educational Clinical Monitoring
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Interpersonal Psychotherapy for Prevention		Educational Clinical Monitoring
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Interpersonal Psychotherapy for Prevention		Educational Clinical Monitoring
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/5 (0%)

Limitations/Caveats

Limitations include a very small sample size due to recruitment difficulty. In addition, participation with follow-up evaluations was poor.

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.