Clinical trial NCT04784858: Integrating a Parenting Intervention Into Substance Use Treatment: A Feasibility Study
Official title: Integrating a Parenting Intervention Into Substance Use Treatment: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parenting
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Niagara Health System
name: house of sophrosyne
First posted: 2021-03-05
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mothers who experience vulnerability and are challenged by substance use disorder trauma, and/or poverty.

Brief summary: While motherhood is central to the design of maternal integrated substance use treatment programs, "evidence-based" parenting interventions tailored to the needs of the population are rare. Stakeholder engagement has revealed that the evidence-base is not reflective of the needs of client population. With 34 ECD programs in Ontario, ECD programs are unique position to pilot Attachment and Biobehavioral Catch Up (ABC) and see if it is a good fit for their clients and if it is effective and feasible. ABC is 10-week evidence-based parenting intervention for parents who live in the context of complex risk, including mental health, addictions, child welfare involvement, and poverty. Investigators of this project will complete a open label mixed method feasibility pilot study involving active implementation of ABC that will involve: 1. exploration facilitators and barriers of the year-long implementation and training process and 2. exploration of changes in maternal mental health, substance use and parenting outcomes from beginning to end of treatment. Results of this mixed method pilot study will inform a larger trial with a control group and support a funding application to support its completion.

Detailed description: While motherhood is central to the design of maternal integrated substance use treatment programs, there are few "evidence-based" parenting interventions tailored to the needs of the population. This study will address this limitation in current parenting intervention research by exploring if Attachment and Biobehavioral Catch Up (ABC) is well suited and feasible to implement within integrated maternal substance use outpatient treatment. ABC is 10-week evidence-based parenting intervention for parents who live in the context of complex risk, including mental health, addictions, child welfare involvement, and poverty. Investigators of this project will complete a open label mixed method feasibility pilot study involving active implementation of ABC that will involve: 1. exploration facilitators and barriers of the year-long implementation and training process and 2. exploration of changes in maternal mental health, substance use and parenting outcomes from beginning to end of treatment. Results of this mixed method pilot study will inform a larger trial with a control group and support a funding application to support its completion.

Eligibility criteria: Inclusion Criteria:

* Women pregnant/parenting children ages 6-24 months
* Women that are clients of participating ECD agencies

Exclusion Criteria:

-

Primary outcomes:
measure: Maternal Sensitivity
timeFrame: 9 minutes play session
Secondary outcomes:
measure: Reflective Functioning
timeFrame: 5 minutes
measure: Parental Reflective Functioning
timeFrame: 5 minutes
measure: Depression, Anxiety, and Stress
timeFrame: 8 minutes
measure: Parenting Stress
timeFrame: 10 minutes
measure: Perceived Social Support
timeFrame: 5 minutes
measure: Difficulties in Emotion Regulation
timeFrame: 5 minutes
measure: Substance use screener
timeFrame: 2 minutes
measure: Interpersonal Emotion Regulation
timeFrame: 8 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Ryerson University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Karen Milligan, PhD
role: PRINCIPAL_INVESTIGATOR
References: