Parenting Intervention for Mothers With Substance Use Disorder

NCT ID: NCT06489522

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-17
• Study Completion Date: 2026-03-31

Brief Summary

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.

Conditions

Substance Use Disorders; Children of Mothers With Substance Use Disorders

Keywords

Parent Child Interaction Therapy (PCIT); Effective parenting skills; THRIVE; SOFAR clinic; Boston Medical Center

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

THRIVE

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mei Elansary, MD MPhil

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Pediatrics

Locations

Boston Medical Center, SOFAR Clinic

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-44513

Identifier Type: -

Identifier Source: org_study_id