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Enhancing Delivery of Parenting Support Within a Peer Recovery Support Service Model

18. august 2026 opdateret af: Elizabeth Peacock-Chambers, MD, Baystate Medical Center

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

288

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Baystate Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Implementation Support
Relational Health Enhanced Parenting Support (RHEP) + FIRST Steps Together (FST)
Andet: Relational Health Enhanced Parenting Support (RHEP) implementation bundle
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.
Aktiv komparator: Usual Care Control
FIRST Steps Together alone
Adfærdsmæssigt: First Steps Together
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Parenting Related Factors
Tidsramme: 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
Baseline, 1, 3, and 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Child Protective Service Involvement
Tidsramme: Baseline, 1, 3 and 6 months
Child Protective Service (CPS) involvement assessed using the CPS Involvement Scale, a 4-item self-report measure developed for this study to evaluate participants' involvement with child protective services. Higher scores indicate greater CPS involvement.
Baseline, 1, 3 and 6 months
Substance Use Disorder (SUD) Treatment Retention
Tidsramme: Baseline, 1, 3 and 6 months

A composite of three parent measures including:

SUD Service Engagement - SUD treatment Service Log (type, count); SUD Service Retention - Duration in FST (days); Desire to Continue Services - Service Engagement Survey
Baseline, 1, 3 and 6 months
Substance Use
Tidsramme: Baseline, 1, 3 and 6 months
The Timeline Followback (TLFB) is a method to assess recent drug use. It involves asking clients to retrospectively estimate their drug use 7 days to 2 years prior to the interview date. TLFB data can be scored in various ways to quantify different aspects of substance use - for this study, we are looking at whether participants have recent drug use or not.
Baseline, 1, 3 and 6 months
Depression
Tidsramme: Baseline, 1, 3 and 6 months
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report measure of depression symptom severity. Higher scores indicate greater depressive symptom severity.
Baseline, 1, 3 and 6 months
Anxiety
Tidsramme: Baseline, 1, 3 and 6 months
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report measure of anxiety symptom severity. Higher scores indicate greater anxiety symptom severity.
Baseline, 1, 3 and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Baystate Medical Center

Samarbejdspartnere

University of California, Irvine

Efterforskere

  • Ledende efterforsker: Elizabeth Peacock-Chambers, MD, MSc, Baystate Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

30. september 2029

Studieafslutning (Anslået)

31. august 2030

Datoer for studieregistrering

Først indsendt

29. juli 2026

Først indsendt, der opfyldte QC-kriterier

29. juli 2026

Først opslået (Faktiske)

3. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2422062

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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