Clinical trial NCT04752618: Safe Mothers, Safe Children Initiative
Official title: Treating Maternal PTSD to Enhance and Reduce Maltreatment Recidivism: Safe Mothers, Safe Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Depression
Child Maltreatment
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: P-STAIR vs Supportive Counseling
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5)
timeFrame: 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
measure: Center for Epidemiological Studies-Depression (CES-D)
timeFrame: 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
measure: Dyadic Parent-Child Interaction Coding System-IV (DPICS)
timeFrame: 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
measure: New foster care removals
timeFrame: Every six-months for 10 years
measure: New child abuse/neglect welfare reports
timeFrame: Every six-months for 10 years
measure: Family Preservation Services Usual Care (FPSUC) reports
timeFrame: Throughout study completion, an average 43 weeks
Secondary outcomes:
measure: Structured Clinical Interview for DSM-5 (SCID-5)
timeFrame: 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
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 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
measure: Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1)
timeFrame: Change from baseline (pre-treatment) to end of treatment (average 43 weeks) to six-month follow-up
measure: Treatment Services Review (TSR)
timeFrame: Baseline (pre-treatment)
measure: Treatment Services Review (TSR)
timeFrame: End of treatment (an average 43 weeks)
measure: Treatment Services Review (TSR)
timeFrame: Follow-up after treatment completion (six-months after end of treatment)
measure: Therapy Acceptability and Expectations (TAE)
timeFrame: 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
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 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
Other outcomes:
Locations:
city: New York
country: United States
facility: McSilver Institute for Poverty Policy and Research
state: New York
Study officials:
affiliation: New York University
name: Michael A Lindsey
role: PRINCIPAL_INVESTIGATOR
References: