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

18 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

288

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Massachusetts
      • Springfield, Massachusetts, Estados Unidos, 01199
        • Baystate Medical Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Implementation Support
Relational Health Enhanced Parenting Support (RHEP) + FIRST Steps Together (FST)
Outro: 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.
Comparador Ativo: Usual Care Control
FIRST Steps Together alone
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Parenting Related Factors
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Child Protective Service Involvement
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Baystate Medical Center

Colaboradores

University of California, Irvine

Investigadores

  • Investigador principal: Elizabeth Peacock-Chambers, MD, MSc, Baystate Health

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

30 de setembro de 2029

Conclusão do estudo (Estimado)

31 de agosto de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

29 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de julho de 2026

Primeira postagem (Real)

3 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2422062

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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