Parenting Intervention for Mothers With Substance Use Disorder
Completed · Not applicable
Conditions studied: Substance Use Disorders, Children of Mothers With Substance Use Disorders
In brief
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.
Key facts
- Study ID
- NCT06489522
- Run by
- Boston Medical Center
- People needed
- 9
- Starts
- 2025-01-17
- Expected to finish
- 2025-10-30
- Last updated by the study team
- 2026-04-07
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Boston Medical Center, SOFAR Clinic — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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