Safe Mothers, Safe Children Initiative

Depression Clinical Trial

— SMSC  

Official title:

Treating Maternal PTSD to Enhance and Reduce Maltreatment Recidivism: Safe Mothers, Safe Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04752618
• Other study ID #: IRB-FY2021-5220
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: August 2023
• Source: New York University
• Contact: Kathleen Brody
• Phone: 212-998-4296
• Email: kathleen.brody[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Receiving preventive services
• Meeting a severity score of 28 or higher OR probable DSM-5 diagnostic criteria for PTSD (PDS-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 a diagnosis of severe substance or alcohol use disorder (= 6 symptoms on SCID) AND not in early remission (=3 months without meeting any substance or alcohol use disorder criteria (except craving)
• Having current or active symptoms of psychosis in the past month
• Having a disability affecting communication, such as deafness
• Having an index child with a developmental condition that impedes cognitive and/or physical functioning, e.g. autism
• Having an index child with current symptoms or diagnosis of psychosis as defined by the DSM-5 in the past 3 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

Related Conditions & MeSH terms

• Child Maltreatment
• Depression
• PTSD

Intervention

Behavioral:
• P-STAIR
PCIT+ STAIR
• Supportive Counseling
Non-trauma focused psychotherapy

Locations

Country	Name	City	State
United States	McSilver Institute for Poverty Policy and Research	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5)	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. PDS-5 is also used during the baseline to evaluate for inclusion/exclusion criteria.	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
Primary	Center for Epidemiological Studies-Depression (CES-D)	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.	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
Primary	Dyadic Parent-Child Interaction Coding System-IV (DPICS)	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.	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
Primary	New foster care removals	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.	Every six-months for 10 years
Primary	New child abuse/neglect welfare reports	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.	Every six-months for 10 years
Primary	Family Preservation Services Usual Care (FPSUC) reports	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.	Throughout study completion, an average 43 weeks
Secondary	Clinician-administered Post-Traumatic Stress Disorder Scale for DSM-5 (CAPS-5)	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, optional after baseline (pre-treatment), will be used to assess change in PTSD diagnosis criteria and severity over treatment implementation.	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
Secondary	Structured Clinical Interview for DSM-5 (SCID-5)	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.	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
Secondary	Difficulties in Emotion Regulation Scale (DERS)	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.	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
Secondary	Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1)	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.	Change from baseline (pre-treatment) to end of treatment (average 43 weeks) to six-month follow-up
Secondary	Treatment Services Review (TSR)	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.	Baseline (pre-treatment)
Secondary	Treatment Services Review (TSR)	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.	End of treatment (an average 43 weeks)
Secondary	Treatment Services Review (TSR)	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.	Follow-up after treatment completion (six-months after end of treatment)
Secondary	Therapy Acceptability and Expectations (TAE)	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.	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
Secondary	Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR)	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.	Baseline (pre-treatment)
Secondary	Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR)	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.	End of treatment (an average 43 weeks)
Secondary	Traumatic Events Screening Inventory - Parent Report Revised (TESI-PRR)	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.	Follow-up after treatment completion (six-months after end of treatment)
Secondary	Strengths and Difficulties Questionnaire (SDQ)	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.	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
Secondary	Children's Behavior Questionnaire - Very Short Form (CBQ-VSF)	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.	Change from baseline (pre-treatment) to end of treatment (average 43 weeks) to six-month follow-up
Secondary	Eyberg Child Behavior Inventory (ECBI)	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.	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