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Clinical Trials/NCT07743359
NCT07743359Not yet recruitingNot Applicable

Relational Health Enhanced Parenting Support (RHEP) Type 2 Hybrid Effectiveness-Implementation Study

Baystate Medical Center1 site in 1 country288 target enrollmentStarted: October 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
288
Locations
1
Primary Endpoint
Parenting Related Factors

Study Overview

Brief Summary

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:

  1. Does FST plus RHEP improve parenting-related outcomes, substance use disorder treatment retention, and reduction in substance use compared with FST alone?
  2. 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:

  1. Receive family-focused peer recovery support services through the FIRST Steps Together (FST) program;
  2. Complete surveys and assessments related to parenting, recovery, and substance use over time;
  3. Participate in follow-up data collection to evaluate treatment retention and recovery outcomes.

Peer recovery support specialists participating in the study will:

  1. Receive training and consultation.
  2. Use implementation tools and supports designed to improve delivery of evidence-based parenting support.
  3. Participate in implementation-related assessments and activities.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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).

Exclusion Criteria

  • Parents who are actively suicidal or homicidal or not able to give informed consent because of severe cognitive impairments or psychosis

Arms & Interventions

Implementation Support

Experimental

Relational Health Enhanced Parenting Support (RHEP) + FIRST Steps Together (FST)

Intervention: Relational Health Enhanced Parenting Support (RHEP) implementation bundle (Other)

Usual Care Control

Active Comparator

FIRST Steps Together alone

Intervention: First Steps Together (Behavioral)

Outcomes

Primary Outcomes

Parenting Related Factors

Time Frame: 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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elizabeth Peacock-Chambers, MD

Associate Professor

Baystate Medical Center

Study Sites (1)

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