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NCT06489522 · ClinicalTrials.gov registry record · NA

Parenting Intervention for Mothers With Substance Use Disorder

A NA study of Substance Use Disorders and Children of Mothers With Substance Use Disorders, sponsored by Boston Medical Center.

Active
Registry status
NA
Development phase
9
Enrollment target
1
Study location

NCT06489522 is a NA study of Substance Use Disorders and Children of Mothers With Substance Use Disorders that is active but no longer recruiting, run by Boston Medical Center. The registered enrollment target is 9 participants, below the 500-participant average among 93 other Substance Use Disorders trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06489522, a NA study of Substance Use Disorders and Children of Mothers With Substance Use Disorders, is active but no longer recruiting, sponsored by Boston Medical Center.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
9 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • BEHAVIORAL THRIVE

Study Locations (1)

Massachusetts

  • Boston Medical Center, SOFAR Clinic - Boston

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2025-01-17
Est. Completion 2026-03
Phase NA

Sponsor

Boston Medical Center

253 total trials

What the Registry Record Tells You About NCT06489522

The ClinicalTrials.gov registry entry for NCT06489522 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 500-participant average among 93 other Substance Use Disorders trials with a reported enrollment target (98% lower). The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Substance Use Disorders appearing as the primary indexed condition, and to 1 intervention - of which THRIVE is the first listed.

NCT06489522 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06489522 about?

NCT06489522 is a clinical study titled "Parenting Intervention for Mothers With Substance Use Disorder". 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 developmen...

What is the current status of trial NCT06489522?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 9 participants. The study started on 2025-01-17. Estimated completion is 2026-03.

What conditions does trial NCT06489522 study?

This clinical trial studies the following conditions: Substance Use Disorders, Children of Mothers With Substance Use Disorders.

What interventions are being tested in trial NCT06489522?

The interventions under investigation include: THRIVE (BEHAVIORAL).

Who is sponsoring clinical trial NCT06489522?

This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06489522 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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