NCT07743359

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. 1.Does FST plus RHEP improve parenting-related outcomes, substance use disorder treatment retention, and reduction in substance use compared with FST alone?
  2. 2.How do implementation processes vary across sites, and what role do peer recovery support specialists play in implementation and effectiveness outcomes?
  3. 3.Receive family-focused peer recovery support services through the FIRST Steps Together (FST) program;
  4. 4.Complete surveys and assessments related to parenting, recovery, and substance use over time;
  5. 5.Participate in follow-up data collection to evaluate treatment retention and recovery outcomes.
  6. 6.Receive training and consultation.
  7. 7.Use implementation tools and supports designed to improve delivery of evidence-based parenting support.
  8. 8.Participate in implementation-related assessments and activities.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
48mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2029

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2030

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

July 29, 2026

Last Update Submit

July 29, 2026

Conditions

Substance Use Disorders (SUDs)

Keywords

parentingsubstance use disorderspeer recovery support

Outcome Measures

Primary Outcomes (1)

  • Parenting Related Factors

    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

    Baseline, 1, 3, and 6 months

Secondary Outcomes (5)

  • 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

Study Arms (2)

Implementation Support

EXPERIMENTAL

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

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

Usual Care Control

ACTIVE COMPARATOR

FIRST Steps Together alone

Behavioral: First Steps Together

Interventions

Relational Health Enhanced Parenting Support (RHEP) implementation bundleOTHER

Relational Health Enhanced Parenting support (RHEP) is an implementation bundle to promote more effective delivery of evidence-based parenting services within the PRSS model. It encompasses three primary implementation strategies: 1) Mirror training, 2) reflective consultation, 3) implementation blueprint. RHEP is delivered at the agency level for all FST staff with the intent to shift practice towards a more strengths-based, process-oriented, relational approach to enhance reflection within organizations and between peers and parents.

Implementation Support
First Steps TogetherBEHAVIORAL

FIRST (Families in Recovery SupporT) Steps Together (FST) is centered on the Peer Recovery Support Service (PRSS) model and involves service delivery by people with lived SUD experience combined with specialized training. PRSS can employ case management, patient navigation, mentoring, or public health education strategies to assist with the unique needs of parents with SUDs in connecting to care, navigating child welfare systems, and preventing future substance misuse and overdose. By virtue of their lived experience, peers may serve as critical liaisons or ambassadors between systems of care and clients. FST further combines evidence-based parent home visiting with peer-led recovery supports to provide flexible, trauma-informed, community-based outreach and care. Mental health clinicians are affiliated with each site.

Usual Care Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (2)

  • Lowell AF, Peacock-Chambers E, Zayde A, DeCoste CL, McMahon TJ, Suchman NE. Mothering from the Inside Out: Addressing the Intersection of Addiction, Adversity, and Attachment with Evidence-Based Parenting Intervention. Curr Addict Rep. 2021;8(4):605-615. doi: 10.1007/s40429-021-00389-1. Epub 2021 Jul 15.

    PMID: 34306964BACKGROUND

  • Lowell AF, DeCoste C, Dalton R, Dias H, Borelli JL, Martino S, McMahon TJ, Suchman NE. Mothering from the Inside Out: Results of a community-based randomized efficacy trial testing a mentalization-based parenting intervention for mothers with addictions. Infant Ment Health J. 2023 Mar;44(2):142-165. doi: 10.1002/imhj.22043. Epub 2023 Mar 2.

    PMID: 36862381BACKGROUND

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Elizabeth Peacock-Chambers, MD, MSc

    Baystate Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Peacock-Chambers, MD, MSc

CONTACT

413-794-8301Elizabeth.Peacock-ChambersMD@baystatehealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Stepped-wedge study model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 3, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

August 31, 2030

Last Updated

August 3, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) collected throughout the study will be shared, including demographic data, survey and assessment results, coded qualitative interview data, and implementation process measures from participating parents and peer recovery support specialists. Direct identifiers and other information that could reasonably identify participants will not be shared. Accompanying documentation, including study protocols, survey instruments, interview guides, fidelity measures, codebooks, procedure manuals, and data dictionaries, will also be made available. Data will be shared in accordance with the study Data Management and Sharing Plan and made publicly available through a HEAL-approved repository.

More information

Locations

US(1)