ACTIVE_NOT_RECRUITING

Parenting Intervention for Mothers With Substance Use Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-17
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06489522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English speaking
  2. * ≥ 18 years of age
  3. * 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
  4. * Primary caregiver to the index child,
  5. * 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.
  6. * Between 3 years, 0 months to 6 years, 11 months of age,
  7. * Enrolled mother is primary caregiver.
  8. * Embedded social worker in the SOFAR program delivering the THRIVE intervention
  9. * Patient Navigators, program manager, pediatricians, peer recovery coaches involved in the care of mother-child dyads in the SOFAR Program.
  1. * 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)
  2. * Severe cognitive limitation or medical or psychiatric condition that limits their capacity to provide informed consent
  3. * Concurrent participation in another parent training intervention
  4. * Has any complex medical problems (as assessed by their pediatrician) that significantly impact the child's ability to interact with the mother.

Contacts and Locations

Principal Investigator

Mei Elansary, MD MPhil
PRINCIPAL_INVESTIGATOR
Boston Medical Center, Pediatrics

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Boston Medical Center

  • Mei Elansary, MD MPhil, PRINCIPAL_INVESTIGATOR, Boston Medical Center, Pediatrics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-17
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-01-17
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Substance Use Disorders
  • Children of Mothers With Substance Use Disorders