Safe Mothers, Safe Children Initiative

Official title

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

Overview

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 1-10 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 clinicians who deliver the study interventions are also considered participants in SMSC. They are not randomized to treatment arms; they are assigned to work with participants in both treatment arms. The study clinicians complete therapist-versions of certain assessment measures throughout the course of the study in order for researchers to assess the working relationship between study clinicians and the mothers they are administering treatment to.

Interventions

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

Primary outcome measures

• Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5) [Time frame: 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) [Time frame: 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]
• Dyadic Parent-Child Interaction Coding System-IV (DPICS) [Time frame: 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]
• New foster care removals [Time frame: Every six-months for 10 years]
• New child abuse/neglect welfare reports [Time frame: Every six-months for 10 years]
• Family Preservation Services Usual Care (FPSUC) reports [Time frame: Throughout study completion, an average 43 weeks]

Secondary outcome measures (9)

• Structured Clinical Interview for DSM-5 (SCID-5) [Time frame: 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]
• Difficulties in Emotion Regulation Scale (DERS) [Time frame: 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]
• Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1) [Time frame: Change from baseline (pre-treatment) to end of treatment (average 43 weeks) to six-month follow-up]
• Treatment Services Review (TSR) [Time frame: Baseline (pre-treatment)]
• Treatment Services Review (TSR) [Time frame: End of treatment (an average 43 weeks)]
• Treatment Services Review (TSR) [Time frame: Follow-up after treatment completion (six-months after end of treatment)]
• Therapy Acceptability and Expectations (TAE) [Time frame: 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) [Time frame: 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]
• Working Alliance Inventory Short Form (WAI-S) [Time frame: Change from mid-treatment at session 9 and 16 to upon completion of treatment (an average of 15 weeks).]

Eligibility criteria

Inclusion Criteria (mothers):

• Receiving preventive services at the time of the consent session to participate in the study
• Meeting a severity score of 28 or higher OR probable DSM-5 diagnostic criteria for PTSD (PDS-5)
• Having 1-10-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 (mothers):

• 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

Inclusion criteria (clinicians):

\- Must be a currently or formerly hired Study Clinician or Clinical Director with Safe Mothers, Safe Children.

Exclusion criteria (clinicians):

\- There are no exclusion criteria for this population. Participants in this population will cease completion of therapist-copy measures upon the conclusion of their role with Safe Mothers, Safe Children, or upon withdrawal from participation in these measures.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• McSilver Institute for Poverty Policy and Research — New York

Identifiers

NCT: NCT04752618 · IRB-FY2021-5220

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗