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

18. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

288

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Massachusetts
      • Springfield, Massachusetts, Vereinigte Staaten, 01199
        • Baystate Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Implementation Support
Relational Health Enhanced Parenting Support (RHEP) + FIRST Steps Together (FST)
Sonstiges: 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.
Aktiver Komparator: Usual Care Control
FIRST Steps Together alone
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Parenting Related Factors
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Child Protective Service Involvement
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Baystate Medical Center

Mitarbeiter

University of California, Irvine

Ermittler

  • Hauptermittler: Elizabeth Peacock-Chambers, MD, MSc, Baystate Health

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

30. September 2029

Studienabschluss (Geschätzt)

31. August 2030

Studienanmeldedaten

Zuerst eingereicht

29. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juli 2026

Zuerst gepostet (Tatsächlich)

3. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2422062

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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