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

September 13, 2021 updated by: Karen Milligan, Ryerson University
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5B2K3
        • Recruiting
        • Ryerson University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Mothers who experience vulnerability and are challenged by substance use disorder trauma, and/or poverty.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Sensitivity
Time Frame: 9 minutes play session
Coded from observed parent-child interactions
9 minutes play session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reflective Functioning
Time Frame: 5 minutes
Reflective Function (RF) 18-item questionnaire
5 minutes
Parental Reflective Functioning
Time Frame: 5 minutes
Reflective Function Questionnaire (PRF-Q) 8-item questionnaire
5 minutes
Depression, Anxiety, and Stress
Time Frame: 8 minutes
Depression, Anxiety and Stress Scale (DASS21) - 21 item questionnaire
8 minutes
Parenting Stress
Time Frame: 10 minutes
Parental Stress Index (PSI) - Short Form, 36 item questionnaire
10 minutes
Perceived Social Support
Time Frame: 5 minutes
Multidimensional Scale of Perceived Social Support (MSPS), 12 item questionnaire
5 minutes
Difficulties in Emotion Regulation
Time Frame: 5 minutes
Difficulties in Emotion Regulation Scale-SF (DERS-SF), 18-item questionnaire
5 minutes
Substance use screener
Time Frame: 2 minutes
Global Appraisal of Individual Needs (Substance Use) (GAIN), 5-item questionnaire
2 minutes
Interpersonal Emotion Regulation
Time Frame: 8 minutes
Interpersonal Emotion Regulation Questionnaire (IERQ), 20-item
8 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karen Milligan, PhD, Ryerson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • ABCforECD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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