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

Sponsor
Ryerson University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04784858
Collaborator
Niagara Health System (Other), house of sophrosyne (Other)
34
Enrollment
1
Location
11
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    34 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Integrating a Parenting Intervention Into Substance Use Treatment: A Feasibility Study
    Actual Study Start Date :
    May 1, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2022
    Anticipated Study Completion Date :
    Apr 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Maternal Sensitivity [9 minutes play session]

      Coded from observed parent-child interactions

    Secondary Outcome Measures

    1. Reflective Functioning [5 minutes]

      Reflective Function (RF) 18-item questionnaire

    2. Parental Reflective Functioning [5 minutes]

      Reflective Function Questionnaire (PRF-Q) 8-item questionnaire

    3. Depression, Anxiety, and Stress [8 minutes]

      Depression, Anxiety and Stress Scale (DASS21) - 21 item questionnaire

    4. Parenting Stress [10 minutes]

      Parental Stress Index (PSI) - Short Form, 36 item questionnaire

    5. Perceived Social Support [5 minutes]

      Multidimensional Scale of Perceived Social Support (MSPS), 12 item questionnaire

    6. Difficulties in Emotion Regulation [5 minutes]

      Difficulties in Emotion Regulation Scale-SF (DERS-SF), 18-item questionnaire

    7. Substance use screener [2 minutes]

      Global Appraisal of Individual Needs (Substance Use) (GAIN), 5-item questionnaire

    8. Interpersonal Emotion Regulation [8 minutes]

      Interpersonal Emotion Regulation Questionnaire (IERQ), 20-item

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Women pregnant/parenting children ages 6-24 months

    • Women that are clients of participating ECD agencies

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ryerson University Toronto Ontario Canada M5B2K3

    Sponsors and Collaborators

    • Ryerson University
    • Niagara Health System
    • house of sophrosyne

    Investigators

    • Principal Investigator: Karen Milligan, PhD, Ryerson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karen Milligan, Associate Professor, Ryerson University
    ClinicalTrials.gov Identifier:
    NCT04784858
    Other Study ID Numbers:
    • ABCforECD
    First Posted:
    Mar 5, 2021
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Substance-Related Disorders

    Study Results

    No Results Posted as of Sep 16, 2021