Safe Mothers, Safe Children Initiative

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Every six-months for 10 years]
• New child abuse/neglect welfare reports [Срок оценки: Every six-months for 10 years]
• Family Preservation Services Usual Care (FPSUC) reports [Срок оценки: Throughout study completion, an average 43 weeks]

Вторичные конечные точки (9)

• Structured Clinical Interview for DSM-5 (SCID-5) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Change from baseline (pre-treatment) to end of treatment (average 43 weeks) to six-month follow-up]
• Treatment Services Review (TSR) [Срок оценки: Baseline (pre-treatment)]
• Treatment Services Review (TSR) [Срок оценки: End of treatment (an average 43 weeks)]
• Treatment Services Review (TSR) [Срок оценки: Follow-up after treatment completion (six-months after end of treatment)]
• Therapy Acceptability and Expectations (TAE) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Change from mid-treatment at session 9 and 16 to upon completion of treatment (an average of 15 weeks).]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• McSilver Institute for Poverty Policy and Research — New York

Идентификаторы

NCT: NCT04752618 · IRB-FY2021-5220

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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