- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07743359
Enhancing Delivery of Parenting Support Within a Peer Recovery Support Service Model
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:
- Does FST plus RHEP improve parenting-related outcomes, substance use disorder treatment retention, and reduction in substance use compared with FST alone?
- 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:
- Receive family-focused peer recovery support services through the FIRST Steps Together (FST) program;
- Complete surveys and assessments related to parenting, recovery, and substance use over time;
- Participate in follow-up data collection to evaluate treatment retention and recovery outcomes.
Peer recovery support specialists participating in the study will:
- Receive training and consultation.
- Use implementation tools and supports designed to improve delivery of evidence-based parenting support.
- Participate in implementation-related assessments and activities.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Elizabeth Peacock-Chambers, MD, MSc
- Telefonní číslo: 413-794-8301
- E-mail: Elizabeth.Peacock-ChambersMD@baystatehealth.org
Studijní místa
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Massachusetts
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Springfield, Massachusetts, Spojené státy, 01199
- Baystate Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Implementation Support
Relational Health Enhanced Parenting Support (RHEP) + FIRST Steps Together (FST)
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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.
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Aktivní komparátor: Usual Care Control
FIRST Steps Together alone
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Parenting Related Factors
Časové okno: Baseline, 1, 3, and 6 months
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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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Child Protective Service Involvement
Časové okno: Baseline, 1, 3 and 6 months
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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.
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Baseline, 1, 3 and 6 months
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Substance Use Disorder (SUD) Treatment Retention
Časové okno: 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
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Substance Use
Časové okno: Baseline, 1, 3 and 6 months
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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.
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Baseline, 1, 3 and 6 months
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Depression
Časové okno: Baseline, 1, 3 and 6 months
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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.
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Baseline, 1, 3 and 6 months
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Anxiety
Časové okno: Baseline, 1, 3 and 6 months
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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.
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Baseline, 1, 3 and 6 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Elizabeth Peacock-Chambers, MD, MSc, Baystate Health
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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