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Parenting Programs for Substance Abuse-related Parent-Child Relationship Issues

N/A
Recruiting
Research Sponsored by University of Ottawa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from pre-intervention to 12 months after engagement and 24 months after engagement
Awards & highlights

Summary

This trial will compare two programs for substance-involved mothers to determine if one is more effective in enhancing infant mental health, decreasing child ACEs, and improving parenting attitudes & mother-child relationship.

Who is the study for?
This trial is for English-speaking mothers with a child under 6 years old, who are receiving services at either the Breaking the Cycle (BTC) or Maxxine Wright (MW) programs due to substance involvement.Check my eligibility
What is being tested?
The study compares two programs: BTC, which includes infant mental health care, and MW, focusing on mothers. It evaluates effects on children's mental health and mother-child relationships over a period of up to 2 years post-intervention.See study design
What are the potential side effects?
Since this trial involves social and educational interventions rather than medical treatments, traditional physical side effects are not applicable. However, participants may experience emotional or psychological discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from pre-intervention to 12 months after engagement and 24 months after engagement
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre-intervention to 12 months after engagement and 24 months after engagement for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Children's developmental functioning will be measured using the Ages and Stages Questionnaire-Third Edition (ASQ-3)
Children's socio-emotional functioning will be measured using the Ages and Stages Questionnaire-Social Emotional (ASQ-SE-2)
Secondary outcome measures
Children's exposure to risk and protective factors will be measured using a cumulative risk measure (Bondi et al., 2020)
Maternal adverse childhood experiences (ACEs) will be measured using a Maternal ACEs Measure (Felitti et al., 1998; Dube et al., 2003)
Maternal anxiety will be measured using the Beck Anxiety Inventory (BAI)
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Breaking the Cycle Intervention groupExperimental Treatment1 Intervention
Group II: Maxxine Wright Intervention groupActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of OttawaLead Sponsor
210 Previous Clinical Trials
268,089 Total Patients Enrolled

Media Library

Breaking the Cycle Program Clinical Trial Eligibility Overview. Trial Name: NCT05768815 — N/A
Substance Abuse Research Study Groups: Breaking the Cycle Intervention group, Maxxine Wright Intervention group
Substance Abuse Clinical Trial 2023: Breaking the Cycle Program Highlights & Side Effects. Trial Name: NCT05768815 — N/A
Breaking the Cycle Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05768815 — N/A
~67 spots leftby Sep 2026
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