- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04784858
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
- Name: Karen Milligan, PhD
- Phone Number: 557054 4169795000
- Email: cfwise@ryerson.ca
Study Contact Backup
- Name: Erica Rodrigues
- Phone Number: 553235 4169795000
- Email: mothers@ryerson.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B2K3
- Recruiting
- Ryerson University
-
Contact:
- Erica Rodrigues
- Phone Number: 553325 4169795000
- Email: mothers@ryerson.ca
-
Contact:
- Laura Herman
- Phone Number: 553325 4167951255
- Email: cfwise@ryerson.ca
-
-
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.
Sponsor
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
Additional Relevant MeSH Terms
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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