Relational Health Enhanced Parenting Support (RHEP) Type 2 Hybrid Effectiveness-Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Parenting Related Factors
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness and implementation of Relational Health Enhanced Parenting Support (RHEP), an implementation strategy designed to improve delivery of evidence-based parenting support within family-focused peer recovery support services (PRSS), for parents with substance use disorders (SUDs) receiving services through the FIRST Steps Together (FST) home visiting program. The main questions it aims to answer are:
- Does FST plus RHEP improve parenting-related outcomes, substance use disorder treatment retention, and reduction in substance use compared with FST alone?
- How do implementation processes vary across sites, and what role do peer recovery support specialists play in implementation and effectiveness outcomes?
Researchers will compare FST alone to FST plus RHEP to determine whether RHEP enhances parenting support delivery and improves parent and recovery outcomes.
Participants will:
- Receive family-focused peer recovery support services through the FIRST Steps Together (FST) program;
- Complete surveys and assessments related to parenting, recovery, and substance use over time;
- Participate in follow-up data collection to evaluate treatment retention and recovery outcomes.
Peer recovery support specialists participating in the study will:
- Receive training and consultation.
- Use implementation tools and supports designed to improve delivery of evidence-based parenting support.
- Participate in implementation-related assessments and activities.
详细描述
This study evaluates Relational Health Enhanced Parenting Support (RHEP), an implementation strategy designed to strengthen delivery of evidence-based parenting support within family-focused peer recovery support services (PRSS) for families affected by substance use disorders (SUDs). Parents with SUDs often experience challenges in the parent-child relationship that can negatively affect both recovery and child well-being. Although family-focused PRSS models are increasingly used to support families affected by SUDs, peer recovery support specialists may face barriers to integrating parenting support into routine service delivery.
RHEP was developed to address these barriers through a multilevel implementation approach that includes workforce training, consultation, and site-level implementation planning. The study is conducted in partnership with the Massachusetts Department of Public Health through FIRST Steps Together (FST), a statewide home visiting program that uses a family-focused PRSS model.
Using a hybrid type 2 effectiveness-implementation design, the study will examine both the effectiveness of RHEP-enhanced services and the implementation processes required to support adoption across six FST sites. A stepped-wedge cluster randomized design will allow each site to transition from FST alone to FST plus RHEP during the study period. Data collected from participating parents and peer recovery support specialists will be used to evaluate intervention effectiveness, implementation outcomes, and factors that influence successful integration of parenting support within peer-led recovery services. Findings will inform future dissemination of parenting support strategies across peer-led, community-based models of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old or older
- •Newly enrolled in FIRST Steps Together (<1 month)
- •Expecting a child or parenting a child age 0-5 years, with either custody of the child or regularly planned visitation
- •History of SUDs (opioids or stimulants on self-report screening).
排除标准
- •Parents who are actively suicidal or homicidal or not able to give informed consent because of severe cognitive impairments or psychosis
研究组 & 干预措施
Implementation Support
Relational Health Enhanced Parenting Support (RHEP) + FIRST Steps Together (FST)
干预措施: Relational Health Enhanced Parenting Support (RHEP) implementation bundle (Other)
Usual Care Control
FIRST Steps Together alone
干预措施: First Steps Together (Behavioral)
结局指标
主要结局
Parenting Related Factors
时间窗: Baseline, 1, 3, and 6 months
A composite of five parent measures including: Closeness to Child - Inclusion of Other in Self Scale (Parent Version); Parenting Satisfaction - Kansas Parenting Scale; Competence in Parenting Role - Parenting Sense of Competence; Positive Emotion - Positive And Negative Affect Scale (Positive Affect Scale) Parent Emotion Regulation - Parent Emotion Regulation Inventory-2
次要结局
- Child Protective Service Involvement(Baseline, 1, 3 and 6 months)
- Substance Use Disorder (SUD) Treatment Retention(Baseline, 1, 3 and 6 months)
- Substance Use(Baseline, 1, 3 and 6 months)
- Depression(Baseline, 1, 3 and 6 months)
- Anxiety(Baseline, 1, 3 and 6 months)
研究者
Elizabeth Peacock-Chambers, MD
Associate Professor
Baystate Medical Center