Parenting Intervention for Mothers With Substance Use Disorder
NCT Number: NCT06489522
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Substance Use Disorders|Children of Mothers With Substance Use Disorders
Interventions: BEHAVIORAL: THRIVE
Sponsor: Boston Medical Center
Collaborators: Washington University School of Medicine
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10
Completion Date: 2025-12
Locations: Boston Medical Center, SOFAR Clinic, Boston, Massachusetts, 02118, United States

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.

Primary Outcome Measures: 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