Substance Use Disorders (SUDs)NCT07743359
Enhancing Delivery of Parenting Support Within a Peer Recovery Support Service Model
A study testing Relational Health Enhanced Parenting Support (RHEP) implementation bundle and First Steps Together in people with Substance Use Disorders (SUDs), run by Baystate Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders (SUDs)
- What is being tested?
- Relational Health Enhanced Parenting Support (RHEP) implementation bundle and First Steps Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- -Parents who are actively suicidal or homicidal or not able to give informed consent because of severe cognitive impairments or psychosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elizabeth Peacock-Chambers, MD, MSc contact
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: 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?
Read more
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.
Read the detailed description
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.
- Conditions
- Substance Use Disorders (SUDs)
- Being tested
- Relational Health Enhanced Parenting Support (RHEP) implementation bundle, First Steps Together
- Keywords
- parenting, substance use disorders, peer recovery support
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
First Steps TogetherBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Implementation Support | Experimental | Relational Health Enhanced Parenting Support (RHEP) + FIRST Steps Together (FST) Receives: Other: Relational Health Enhanced Parenting Support (RHEP) implementation bundle |
| Usual Care Control | Active comparator | FIRST Steps Together alone Receives: Behavioral: First Steps Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 1, 3, and 6 months
Secondary outcomes (5)
Child Protective Service Involvement
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.
Measured: Baseline, 1, 3 and 6 months
Substance Use Disorder (SUD) Treatment Retention
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
Measured: Baseline, 1, 3 and 6 months
Substance Use
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.
Measured: Baseline, 1, 3 and 6 months
Depression
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.
Measured: Baseline, 1, 3 and 6 months
Anxiety
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.
Measured: Baseline, 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance Use Disorders (SUDs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-wedge study model
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Responsible party
- Principal investigator, Elizabeth Peacock-Chambers, MD, Baystate Medical Center
- Investigators
- Elizabeth Peacock-Chambers, MD, MSc, Principal investigator, Baystate Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743359
- Sponsor's protocol ID
- 2422062
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34306964Lowell 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.
PubMed 36862381
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relational Health Enhanced Parenting Support (RHEP) Type 2 Hybrid Effectiveness-Implementation Study
- ClinicalTrials.gov ID
- NCT07743359
- Acronym / sponsor ID
- 2422062
- Conditions
- Substance Use Disorders (SUDs)
- Keywords
- parenting, substance use disorders, peer recovery support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped-wedge study model
| Arm | Type | Receives |
|---|---|---|
| Implementation Support | Experimental | Other: Relational Health Enhanced Parenting Support (RHEP) implementation bundleRelational Health Enhanced Parenting Support (RHEP) + FIRST Steps Together (FST) |
| Usual Care Control | Active comparator | Behavioral: First Steps TogetherFIRST Steps Together alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- -Parents who are actively suicidal or homicidal or not able to give informed consent because of severe cognitive impairments or psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relational Health Enhanced Parenting Support (RHEP) implementation bundleRelational 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. | Other | Implementation Support |
| First Steps TogetherFIRST (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. | Behavioural | Usual Care Control |
Primary outcome
Parenting Related Factors
Time frame: 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
5 secondary outcomes
Child Protective Service Involvement
Time frame: Baseline, 1, 3 and 6 months
Substance Use Disorder (SUD) Treatment Retention
Time frame: Baseline, 1, 3 and 6 months
Substance Use
Time frame: Baseline, 1, 3 and 6 months
Depression
Time frame: Baseline, 1, 3 and 6 months
Anxiety
Time frame: Baseline, 1, 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 34306964Lowell 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.
- Background: PubMed 36862381Lowell 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.
- A website providing information on several projects related to Mothering from the Inside OutLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Substance Use Disorders (SUDs)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Not yet recruiting
Recovery Opportunities Through Ongoing Treatment Sustainment
Substance Use Disorders (SUDs)
Not yet recruiting
Supportive Treatment With Enhanced Post-Incarceration Services
Substance Use Disorders (SUDs)
Active, not recruiting
Effectiveness of Depression and Substance Use Module for Patients With Co-occurring Disorders
Depression, Substance Use Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Peacock-Chambers, MD, MSc contact
Elizabeth Peacock-Chambers, MD, MSc principal investigator
Baystate Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relational Health Enhanced Parenting Support (RHEP) implementation bundle and First Steps Together in people with Substance Use Disorders (SUDs), run by Baystate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Peacock-Chambers, MD, MSc (413-794-8301, Elizabeth.Peacock-ChambersMD@baystatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Related Factors (time frame: Baseline, 1, 3, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07743359, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.