Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 3 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
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
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Threat, harm, risk, investigation, vulnerability and engagement (THRIVE) intervention
The THRIVE intervention will be offered by a trained therapist to participants (mother-child dyads) in the SOFAR Clinic.
  • Behavioral: THRIVE
    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.

Recruiting Locations

Boston Medical Center, SOFAR Clinic
Boston, Massachusetts 02118
Contact:
Mei Elansary, MD MPhil
617-414-4841
mei.elansary@bmc.org

More Details

Status
Recruiting
Sponsor
Boston Medical Center

Study Contact

Mei Elansary, MD MPhil
617-414-4841
mei.elansary@bmc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.