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Completed

NCT Number: NCT06489522

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 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.

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Children of Mothers With Substance Use Disorders Mental Disorders Substance-Related Disorders

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center, SOFAR Clinic

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Mothers:

  • English speaking
  • ≥ 18 years of age
  • 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
  • Primary caregiver to the index child,
  • 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.

Children:

  • Between 3 years, 0 months to 6 years, 11 months of age,
  • Enrolled mother is primary caregiver.

THRIVE Therapist:

  • Embedded social worker in the SOFAR program delivering the THRIVE intervention

Clinical Stakeholders:

  • Patient Navigators, program manager, pediatricians, peer recovery coaches involved in the care of mother-child dyads in the SOFAR Program.

Exclusion criteria

Mothers:

  • 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)
  • Severe cognitive limitation or medical or psychiatric condition that limits their capacity to provide informed consent
  • Concurrent participation in another parent training intervention

Children:

  • Has any complex medical problems (as assessed by their pediatrician) that significantly impact the child's ability to interact with the mother.

Treatment and study plan

Thrive

Behavioral

THRIVE is a brief, parent child interaction therapy (PCIT) based telehealth intervention delivered over 6-sessions that has been tested in pediatric and community-based settings.

Primary outcomes

  1. Acceptability of the THRIVE intervention

    Time frame: 12 months

    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.

  2. Fidelity of the THRIVE intervention

    Time frame: 12 months

    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.

  3. Feasibility of the THRIVE intervention based on enrollment

    Time frame: 12 months

    The number of families ineligible, approached, and enrolled will be documented from study records.

  4. Total number of THRIVE intervention sessions

    Time frame: 12 months

    The total number of sessions completed will be abstracted from the study records.

  5. Duration of THRIVE intervention sessions

    Time frame: 12 months

    The duration of the sessions will be documented in minutes.

  6. Percent of days homework completed

    Time frame: 12 months

    Percent of days homework completed will be obtained from study records

  7. Feasibility of the THRIVE intervention based on retention

    Time frame: 12 months

    Retention will be assessed by the time to loss of follow-up.

  8. Perceived reasons for discontinuation of THRIVE

    Time frame: 12 months

    The perceived reasons for discontinuation will be documented in the study records.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Washington University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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