Parenting support for mothers with substance use issues
Supporting the Implementation of a Parenting Intervention for Mothers With Substance Use Disorder in the Pediatric Medical Home
This study tests a new parenting program called THRIVE to see if it can help mothers with substance use issues improve their parenting skills and support their young children’s development.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 3 Years and up |
| Sex | All |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06489522 on ClinicalTrials.gov |
What this trial studies
This study evaluates a parenting intervention called THRIVE, designed for mothers with substance use disorders and their young children. The intervention aims to enhance effective parenting skills through Parent Child Interaction Therapy (PCIT) within the supportive environment of the SOFAR clinic at Boston Medical Center. By addressing the unique challenges faced by these families, the program seeks to improve both maternal recovery and child development outcomes. The study focuses on mothers engaged in recovery and their children aged 3 to 6 years, providing a structured approach to foster responsive parenting.
Who should consider this trial
Good fit: Ideal candidates include English-speaking mothers aged 18 and older with a child between 3 and 6 years old who are engaged in formal substance use disorder recovery.
Not a fit: Patients who are not the primary caregivers of a child within the specified age range or who are not engaged in recovery supports may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve parenting skills and child development for families affected by substance use disorders.
How similar studies have performed: Other studies have shown success with similar parenting interventions for families affected by substance use disorders, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Boston Medical Center, SOFAR Clinic — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Mei Elansary, MD MPhil — Boston Medical Center, Pediatrics
- Study coordinator: Mei Elansary, MD MPhil
- Email: mei.elansary@bmc.org
- Phone: 617-414-4841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.