Parenting Intervention for Mothers With Substance Use Disorder

Supporting the Implementation of a Parenting Intervention for Mothers With Substance Use Disorder in the Pediatric Medical Home

Children of mothers with substance use disorder (SUD) constitute a growing and highly vulnerable population. Evidence-based parenting interventions have the potential to both support parents' recovery and mental health by helping them cope with stress of parenthood and promote the optimal development of their children by supporting responsive parenting. The Supporting Our Families through Addiction and Recovery (SOFAR) pediatric medical home for families and children impacted by SUDs, with integrated behavioral health (IBH), provides an opportune setting for addressing the needs of mothers and children impacted by SUDs. While many families are thriving in the program, there is a strong unmet need for evidence-based parent-training interventions, particularly during the preschool period.

This study aims to evaluate the implementation of a brief, parent child interaction therapy (PCIT)-based intervention, entitled Threat, harm, risk, investigation, vulnerability and engagement (THRIVE), that will be offered in the SOFAR Clinic at Boston Medical Center. THRIVE is a safe, 6-session telehealth intervention that has been tested in pediatric and community-based settings. The evidence-based suggests that THRIVE is associated with significant improvements in child behaviors and parenting stress.

The investigators hypothesize that offering THRIVE through the SOFAR pediatric primary care program will be feasible and acceptable, improving access to and engagement in evidence-based parenting interventions among mothers with substance use disorder who receive parenting support through our integrated behavioral health model. In addition to studying the implementation of this evidence-based intervention, this study will allow the researchers to test data collection procedures (pre and post-interventions assessments) to inform a future clinical trial.

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders; Children of Mothers With Substance Use Disorders
• Intervention / Treatment: Behavioral: THRIVE

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center, SOFAR Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Mothers:

• English speaking
• ≥ 18 years of age
• Mother to an index child between 3 years, 0 months to 6 years, 11 months of age who receives primary care at Boston Medical Center
• Primary caregiver to the index child,
• Engaged in formal SUD recovery supports (e.g., medication for opioid use disorder, support groups specific to people in recovery and falls into one of these two enrollment groups: A) "high-risk" substance use disorder defined >=1 episode of relapse within the past two years OR B) "low-risk" defined as zero episodes of relapse within the past two years.

Children:

• Between 3 years, 0 months to 6 years, 11 months of age,
• Enrolled mother is primary caregiver.

THRIVE Therapist:

• Embedded social worker in the SOFAR program delivering the THRIVE intervention

Clinical Stakeholders:

• Patient Navigators, program manager, pediatricians, peer recovery coaches involved in the care of mother-child dyads in the SOFAR Program.

Exclusion Criteria:

Mothers:

• Has an index child who has complex medical problems (e.g., autism spectrum disorder) that significantly impact the child's ability to interact with the parent (determination by child's primary care pediatrician)
• Severe cognitive limitation or medical or psychiatric condition that limits their capacity to provide informed consent
• Concurrent participation in another parent training intervention

Children:

• Has any complex medical problems (as assessed by their pediatrician) that significantly impact the child's ability to interact with the mother.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Threat, harm, risk, investigation, vulnerability and engagement (THRIVE) intervention; The THRIVE intervention will be offered by a trained therapist to participants (mother-child dyads) in the SOFAR Clinic.	Behavioral: THRIVE; THRIVE is a brief, parent child interaction therapy (PCIT) based telehealth intervention delivered over 6-sessions that has been tested in pediatric and community-based settings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the THRIVE intervention	The Therapy Attitude Inventory survey will be used to collect assess mother/birthing parent acceptability of the THRIVE intervention. It is a 16 item instrument with 5 potential response per Question. Scores can range from 16 to 80 and higher scores are associated with higher acceptability.	12 months
Fidelity of the THRIVE intervention	The Treatment Integrity Checklist will be used to assess fidelity. It will be completed by research staff via review of video-recorded THRIVE sessions to monitor adherence to THRIVE core components.	12 months
Feasibility of the THRIVE intervention based on enrollment	The number of families ineligible, approached, and enrolled will be documented from study records.	12 months
Total number of THRIVE intervention sessions	The total number of sessions completed will be abstracted from the study records.	12 months
Duration of THRIVE intervention sessions	The duration of the sessions will be documented in minutes.	12 months
Percent of days homework completed	Percent of days homework completed will be obtained from study records	12 months
Feasibility of the THRIVE intervention based on retention	Retention will be assessed by the time to loss of follow-up.	12 months
Perceived reasons for discontinuation of THRIVE	The perceived reasons for discontinuation will be documented in the study records.	12 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Washington University School of Medicine
• Investigators: Principal Investigator: Mei Elansary, MD MPhil, Boston Medical Center, Pediatrics

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: THRIVE; Parent Child Interaction Therapy (PCIT); Boston Medical Center; Effective parenting skills; SOFAR clinic
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alkaloids; Solanaceous Alkaloids; Nicotine
• Other Study ID Numbers: H-44513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No