Clinical trial NCT06489522: Parenting Intervention for Mothers With Substance Use Disorder
Official title: Supporting the Implementation of a Parenting Intervention for Mothers With Substance Use Disorder in the Pediatric Medical Home
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Children of Mothers With Substance Use Disorders
Keywords: Parent Child Interaction Therapy (PCIT)
Effective parenting skills
THRIVE
SOFAR clinic
Boston Medical Center
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2024-07-08
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Approximately 10 high-risk mother-child dyads (defined as a mother having an episode of relapse in the past two years) and approximately 10 low-risk mother-child dyads (defined as mother not having any episodes of relapse in the past two-years) will be enrolled. There will be 1 therapist and 9 clinical stakeholders (Patient Navigators, program manager, pediatricians, peer recovery coaches involved in the care of mother-child dyads in the SOFAR Program).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of the THRIVE intervention
timeFrame: 12 months
measure: Fidelity of the THRIVE intervention
timeFrame: 12 months
measure: Feasibility of the THRIVE intervention based on enrollment
timeFrame: 12 months
measure: Total number of THRIVE intervention sessions
timeFrame: 12 months
measure: Duration of THRIVE intervention sessions
timeFrame: 12 months
measure: Percent of days homework completed
timeFrame: 12 months
measure: Feasibility of the THRIVE intervention based on retention
timeFrame: 12 months
measure: Perceived reasons for discontinuation of THRIVE
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center, SOFAR Clinic
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Pediatrics
name: Mei Elansary, MD MPhil
role: PRINCIPAL_INVESTIGATOR
References: