Treating Maternal PTSD to Enhance and Reduce Maltreatment Recidivism: Safe Mothers, Safe Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- New foster care removals
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors and preventive case planners are blind to treatment arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: P-STAIR (Behavioral)
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.
干预措施: Supportive Counseling (Behavioral)
结局指标
主要结局
New foster care removals
时间窗: 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.
Center for Epidemiological Studies-Depression (CES-D)
时间窗: 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.
Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5)
时间窗: 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. PDS-5 is also used during the baseline to evaluate for inclusion/exclusion criteria.
Dyadic Parent-Child Interaction Coding System-IV (DPICS)
时间窗: 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.
Family Preservation Services Usual Care (FPSUC) reports
时间窗: 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.
New child abuse/neglect welfare reports
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)
- Treatment Services Review (TSR)(Follow-up after treatment completion (six-months after end of treatment))
- 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)
- Treatment Services Review (TSR)(Baseline (pre-treatment))
- Treatment Services Review (TSR)(End of treatment (an average 43 weeks))
- Working Alliance Inventory Short Form (WAI-S)(Change from mid-treatment at session 9 and 16 to upon completion of treatment (an average of 15 weeks).)