NCT04784858

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

March 2, 2021

Last Update Submit

September 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maternal Sensitivity

    Coded from observed parent-child interactions

    9 minutes play session

Secondary Outcomes (8)

  • Reflective Functioning

    5 minutes

  • Parental Reflective Functioning

    5 minutes

  • Depression, Anxiety, and Stress

    8 minutes

  • Parenting Stress

    10 minutes

  • Perceived Social Support

    5 minutes

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryerson University

Toronto, Ontario, M5B2K3, Canada

RECRUITING

Study Officials

  • Karen Milligan, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Milligan, PhD

CONTACT

Erica Rodrigues

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 5, 2021

Study Start

May 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations