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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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.

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
Boston Medical Center

253 total trials

What the registry record for NCT06489522 still lists

NCT06489522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 500-participant average among 93 other Substance Use Disorders trials with a reported enrollment target (98% lower).

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 a single indexed study location in 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.

Similar trials for Substance Use Disorders

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06489522's enrollment target sits among peer trials

9 93rd of 93 higher than 1 of 93 other Substance Use Disorders trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Substance Use Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06489522, the US trial registry maintained by the National Library of Medicine. NCT06489522 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.