Viewing Study NCT06489522



Ignite Creation Date: 2024-07-17 @ 11:53 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06489522
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-07-08
First Post: 2024-06-28

Brief Title: Parenting Intervention for Mothers With Substance Use Disorder
Sponsor: Boston Medical Center
Organization: Boston Medical Center

Study Overview

Official Title: Supporting the Implementation of a Parenting Intervention for Mothers With Substance Use Disorder in the Pediatric Medical Home
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None