SMSC: Safe Mothers, Safe Children Initiative

Sponsor
New York University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04752618
Collaborator
(none)
220
1
2
53
4.2

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy of the combined interventions, Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT) or P-STAIR, for treating maternal PTSD and reducing maltreatment recidivism.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: P-STAIR
  • Behavioral: Supportive Counseling
N/A

Detailed Description

This study is a two-arm randomized controlled trial (RCT): P-STAIR (23 sessions) vs. supportive counseling (SC) (23 sessions). Eligible cases are randomized to P-STAIR and SC in a 1:1 ratio. Participants will be mothers receiving family preservation services (FPS), with a child in the age range of 1-8 years old, and PTSD (with/without depression). Symptom progress will be measured at pre-treatment, two in-treatment assessments (9 weeks and 16 weeks), post-treatment, and at a 6-month follow-up.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
P-STAIR vs Supportive CounselingP-STAIR vs Supportive Counseling
Masking:
Single (Outcomes Assessor)
Masking Description:
Assessors and preventive case planners are blind to treatment arm.
Primary Purpose:
Treatment
Official Title:
Treating Maternal PTSD to Enhance and Reduce Maltreatment Recidivism: Safe Mothers, Safe Children
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Sep 30, 2025
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: P-STAIR

Participants will receive 23 weekly individual treatment sessions. Each session will last one hour. P-STAIR is a combination of STAIR and PCIT. STAIR focuses on reduction of PTSD symptoms through enhancement of emotion regulation skills. PCIT focuses on the reduction of negative parenting skills and the increase of positive parenting skills.

Behavioral: P-STAIR
PCIT+ STAIR

Active Comparator: Supportive Counseling

Participants will receive 23 weekly individual treatment sessions. Each session will last one hour. Supportive counseling has been modified to permit non-trauma discussion of parenting problems. Each session is client-directed and clinicians take an unconditionally supportive role.

Behavioral: Supportive Counseling
Non-trauma focused psychotherapy

Outcome Measures

Primary Outcome Measures

  1. Clinician-administered Post-Traumatic Stress Disorder Scale for DSM-5 (CAPS-5) [Change from baseline (pre-treatment) to mid-treatment at session 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion]

    Clinician-administered Post-Traumatic Stress Disorder Scale for DSM-5 (CAPS-5) is a 30-item structured interview developed by the U.S. Department of Veterans Affairs National Center for PTSD. It yields a categorical measure of diagnosis and a severity score. Severity scores are calculated from 20 DSM-5 PTSD symptoms and range from 0 ("absent") to 80 ("extreme"). It has strong reliability/validity. CAPS-5 will be used to assess change in PTSD diagnosis criteria and severity over treatment implementation. CAPS-5 is also used during the baseline to evaluate for inclusion/exclusion criteria.

  2. Center for Epidemiological Studies-Depression (CES-D) [Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion]

    Center for Epidemiological Studies-Depression (CES-D) is a 20-item self-report measure of symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Items are rated on a 3-point scale ranging from 0 ("rarely or none of the time") to 3 ("most or almost all of the time"). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. CES-D will be used to assess change in depression symptoms over treatment implementation.

  3. Dyadic Parent-Child Interaction Coding System-IV (DPICS) [Change from baseline (pre-treatment) to mid-treatment at session 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion]

    Dyadic Parent-Child Interaction Coding System-IV (DPICS) examines the quality of parent-child social interaction in three 5-minute situations: child-directed play, parent-directed play, and clean-up. Positive skills include praise, reflect, and describe, and negative skills include questions, commands, and criticisms. Observations are coded by trained DPICS scorers to produce total scores. DPICS scores allow us to track the changes in positive and negative parenting scores over treatment implementation.

  4. New foster care removals [Every six-months for 10 years]

    Data is collected through the New York State Child Welfare Registry (NYSCWR) semi-annually on the number of out-of-home placements for 10 years for completers and non-completers who have consented into the study. Number of new foster care removals are located by unique NYSCWR identifiers collected at time of consent. Out-of-home placement data, in addition to new substantiated welfare reports, will be used to assess recidivism.

  5. New child abuse/neglect welfare reports [Every six-months for 10 years]

    Data is collected through the New York State Child Welfare Registry (NYSCWR) semi-annually on the number of substantiated abuse/neglect reports for 10 years for completers and non-completers who have consented into the study. Number of new substantiated reports are located by unique NYSCWR identifiers collected at time of consent. New substantiated welfare reports, as well as out-of-home placement data, will be used to assess recidivism.

  6. Family Preservation Services Usual Care (FPSUC) reports [Throughout study completion, an average 43 weeks]

    Family Preservation Services Usual Care (FPSUC) is extracted from electronic records that agencies use to document services. FPSUC details the number of services accessed in preventative agencies for clients. Data will be used to statistically control for FPSUC.

Secondary Outcome Measures

  1. Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5) [Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion]

    Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5) is a 24-item self-report measure of PTSD symptoms over the last month. Items are rated on a 5-point scale of frequency and severity ranging from 0 ("not at all") to 4 ("6 or more times a week/severe"). Higher scores indicate more severe PTSD symptoms. PDS-5 will be used to monitor change in PTSD symptoms over treatment implementation.

  2. Structured Clinical Interview for DSM-5 (SCID-5) [Change from baseline (pre-treatment) to mid-treatment at session 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion]

    Structured Clinical Interview for DSM-5 (SCID-5) is the gold standard for determining DSM-5 Axis I current diagnoses and psychiatric history. The SCID-5 depression, alcohol and substance use, and psychosis modules will be used. SCID-5 will be used to track changes in depression, substance use/abuse, and symptoms of psychosis, as well as to evaluate inclusion/exclusion criteria.

  3. Difficulties in Emotion Regulation Scale (DERS) [Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion]

    Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure used to assesses emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation. DERS has adequate construct and predictive validity and good test-retest reliability. DERS will be used to evaluate level of emotion regulation skills during treatment implementation.

  4. Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1) [Change from baseline (pre-treatment) to end of treatment (average 43 weeks) to six-month follow-up]

    Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1) is a self-reporting inventory that measures parental behaviors and is commonly used to assess the risk of child abuse and neglect. Items are rated on a scale of 1 ("strongly agree") to 5 ("strongly disagree"). AAPI-2.1 has five sub-constructs: expectations of children, parental empathy towards children's needs, use of corporal punishment, parent-child family roles, and children's power and independence. Higher scores indicate lower risk of parental abuse/neglect. AAPI will be used to monitor the change in parental behaviors over treatment implementation.

  5. Treatment Services Review (TSR) [Baseline (pre-treatment)]

    Treatment Services Review (TSR) is an interview used to gather information about specific mental health services received outside of the study treatment, lifetime treatment history, and treatment received at the time of the baseline (pre) assessment. It describes treatment type (individual therapy vs. group), provider type (psychologist, psychiatrist, social worker), length (in years) and frequency of treatment (rate of appointments), rate of hospitalizations, and medications prescribed.

  6. Treatment Services Review (TSR) [End of treatment (an average 43 weeks)]

    Treatment Services Review (TSR) is an interview used to gather information about specific mental health services received outside of the study treatment, lifetime treatment history, and treatment received during treatment implementation. It describes treatment type (individual therapy vs. group), provider type (psychologist, psychiatrist, social worker), length (in years) and frequency of treatment (rate of appointments), rate of hospitalizations, and medications prescribed.

  7. Treatment Services Review (TSR) [Follow-up after treatment completion (six-months after end of treatment)]

    Treatment Services Review (TSR) is an interview used to gather information about specific mental health services received outside of the study treatment, lifetime treatment history, and treatment received between the end of treatment and the six-month follow-up assessment. It describes treatment type (individual therapy vs. group), provider type (psychologist, psychiatrist, social worker), length (in years) and frequency of treatment (rate of appointments), rate of hospitalizations, and medications prescribed.

  8. Therapy Acceptability and Expectations (TAE) [Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion]

    Therapy Acceptability and Expectations (TAE) is a 5-item scale that evaluates credibility and engagement of study treatment. Items range from 0 ("not at all") to 8 ("extremely"). Higher scores indicate greater acceptability of treatment. TAE is administered throughout treatment in order to assess the clinician-client therapeutic relationship and client engagement with treatment. Necessary changes that arise from the TAE are addressed in future treatment sessions.

  9. Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR) [Baseline (pre-treatment)]

    Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR) is a 24-item parent-report measure for preschool-age children used to assess frequency and type of child exposure to traumatic events. TESI-PRR is used to monitor exposure to traumatic events at the time of the baseline (pre) assessment.

  10. Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR) [End of treatment (an average 43 weeks)]

    Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR) is a 24-item parent-report measure for preschool-age children used to assess frequency and type of child exposure to traumatic events. TESI-PRR is used to monitor exposure to traumatic events during treatment implementation.

  11. Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR) [Follow-up after treatment completion (six-months after end of treatment)]

    Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR) is a 24-item parent-report measure for preschool-age children used to assess frequency and type of child exposure to traumatic events. TESI-PRR is used to monitor exposure to traumatic events between the end of treatment and the six-month follow-up assessment.

  12. Strengths and Difficulties Questionnaire (SDQ) [Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion]

    Strengths and Difficulties Questionnaire (SDQ) is a 25-item parent-report behavioral screening questionnaire that comprises five sub-scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Items have the following responses: "not true," "somewhat true," and "certainly true." Higher scores indicate a higher likelihood of emotional and/or behavioral difficulties. SDQ will be used throughout treatment to assess change in behavior of the child participating in the parent-child dyadic play observations.

  13. Children's Behavior Questionnaire - Very Short Form (CBQ-VSF) [Change from baseline (pre-treatment) to end of treatment (average 43 weeks) to six-month follow-up]

    Children's Behavior Questionnaire - Very Short Form (CBQ-VSF) is a 36-item parent-report of child temperament. Responses are given on a 7-point scale ranging from 1 ("extremely untrue of my child") to 7 ("extremely true of my child"). The questionnaire has 3 sub-scales: surgency/extraversion, negative affectivity, and effortful control. CBQ-VSF will be used throughout treatment to assess change in temperament of the child participating in the parent-child dyadic play observations.

  14. Eyberg Child Behavior Inventory (ECBI) [Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion]

    Eyberg Child Behavior Inventory (ECBI) is a 36-item parent-report designed to assess conduct issues in children ages 2-16. ECBI asks parents to identify problems through "yes/no" questions. The inventory examines the intensity of problems on a scale from 1 ("never") to 7 ("always"). Higher total problem scores indicate more behaviors are a problem for the parent. Higher total intensity scores indicate higher frequency of behaviors. ECBI will be used throughout treatment to assess change in behavior of the child participating in the parent-child dyadic play observations and rate of parental-identified problems.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Receiving preventive services

  • Meeting DSM-5 diagnostic criteria for PTSD (CAPS-5) with or without co-occurring depression (SCID-5)

  • Having 1-8-year-old child

  • Being the legal guardian for the child with physical and legal custody

  • Being able to read, write, and speak English or Spanish

Exclusion Criteria:
  • Having suicidal ideation present in the past month prior to pre-assessment or reports of a suicide attempt in the past year (SCID-5)

  • Meeting DSM-5 criteria for current substance or alcohol use symptoms or diagnosis in the past month (SCID-5)

  • Having current symptoms or diagnosis of psychosis as defined by the DSM-5 in the past year (SCID-5)

  • Having a disability affecting communication, such as deafness

  • Having an index child with a developmental condition that impedes functioning, e.g. autism spectrum condition

  • Having symptoms of psychosis during childhood in the past three months

  • Experiencing current or history of intimate partner violence (IPV) or family violence:

If there is a history of IPV/family violence and the relationship is no longer active, the relationship must have ended for at least ninety days with no intention of restarting; If there is a history of IPV/family violence, but the relationship is ongoing, there must not have been an IPV/family violence event for at least one year

Contacts and Locations

Locations

Site City State Country Postal Code
1 McSilver Institute for Poverty Policy and Research New York New York United States 10003

Sponsors and Collaborators

  • New York University

Investigators

  • Principal Investigator: Michael A Lindsey, New York University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
New York University
ClinicalTrials.gov Identifier:
NCT04752618
Other Study ID Numbers:
  • IRB-FY2021-5220
First Posted:
Feb 12, 2021
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2022