Integrating a Parenting Intervention Into Substance Use Treatment: A Feasibility Study

Parenting Clinical Trial

Official title:

Integrating a Parenting Intervention Into Substance Use Treatment: A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04784858
• Other study ID #: ABCforECD
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: September 2021
• Source: Ryerson University
• Contact: Karen Milligan, PhD
• Phone: 4169795000
• Email: cfwise[@]ryerson.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women pregnant/parenting children ages 6-24 months
• Women that are clients of participating ECD agencies Exclusion Criteria: -

Related Conditions & MeSH terms

• Parenting
• Substance-Related Disorders

Locations

Country	Name	City	State
Canada	Ryerson University	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Ryerson University	house of sophrosyne, Niagara Health System

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Sensitivity	Coded from observed parent-child interactions	9 minutes play session
Secondary	Reflective Functioning	Reflective Function (RF) 18-item questionnaire	5 minutes
Secondary	Parental Reflective Functioning	Reflective Function Questionnaire (PRF-Q) 8-item questionnaire	5 minutes
Secondary	Depression, Anxiety, and Stress	Depression, Anxiety and Stress Scale (DASS21) - 21 item questionnaire	8 minutes
Secondary	Parenting Stress	Parental Stress Index (PSI) - Short Form, 36 item questionnaire	10 minutes
Secondary	Perceived Social Support	Multidimensional Scale of Perceived Social Support (MSPS), 12 item questionnaire	5 minutes
Secondary	Difficulties in Emotion Regulation	Difficulties in Emotion Regulation Scale-SF (DERS-SF), 18-item questionnaire	5 minutes
Secondary	Substance use screener	Global Appraisal of Individual Needs (Substance Use) (GAIN), 5-item questionnaire	2 minutes
Secondary	Interpersonal Emotion Regulation	Interpersonal Emotion Regulation Questionnaire (IERQ), 20-item	8 minutes