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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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from pre-intervention to 12 months after engagement and 24 months after engagement

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)

+6 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of OttawaLead Sponsor

208 Previous Clinical Trials

267,056 Total Patients Enrolled

Media Library

Breaking the Cycle Program Clinical Trial Eligibility Overview. Trial Name: NCT05768815 — N/A

Substance Abuse Research Study Groups: Maxxine Wright Intervention group, Breaking the Cycle 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation still recruiting participants?

"The latest entry on clinicaltrials.gov shows that this trial, initiated on the 1st of May 2022 and last updated on 3rd March 2023, is not currently accepting participants. However, 358 other studies are actively seeking volunteers for their research projects."

Answered by AI

What do researchers hope to gain from this experiment?

"This medical trial will evaluate the effectiveness of its intervention over a two-year period, assessing children's developmental functioning via the Ages and Stages Questionnaire - Third Edition (ASQ-3). Secondary objectives include examining sensitivity of maternal behaviour through the Maternal Behaviour Q-Sort (MBQS) Brief Version; measuring parental stress with the Parenting Stress Index Short Form (PSI-4-SF); and gauging parenting attitudes by way of the Adult - Adolescent Parenting Inventory Version 2.0 (AAPI - 2 )."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright

2023. "Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05768815.

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