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ATTACH™ Parenting Program for Parent-Child Relationship (ATTACH™ Trial)
N/A
Recruiting
Led By Nicole Letourneau, PhD RN FCAHS
Research Sponsored by University of Calgary
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 baseline pcits scores after completion of intervention and at 3 months.
Awards & highlights
No Placebo-Only Group
Summary
This trial sought to test the efficacy of the ATTACH parenting intervention in reducing stress-related health problems in children. The study found that ATTACH was successful in reducing stress and improving health outcomes for children. However, the study was limited by its small sample size and lack of long-term data.
Who is the study for?
The ATTACH™ Program is for parents with children from birth to 32 months who are dealing with toxic stress factors like depression, addictions, or poverty. Parents must commit to weekly training sessions for 10-12 weeks and agree to bring a co-parent when possible. They also need to consent to blood sample collection in certain locations.
What is being tested?
This trial tests the ATTACH™ Parenting Program's effectiveness when delivered by healthcare professionals in community settings. It aims at improving parent-child relationships and child development outcomes by enhancing parents' understanding of thoughts and feelings (reflective function).
What are the potential side effects?
Since ATTACH™ is an educational program rather than a medical treatment, it doesn't have side effects like drugs do. However, participants may experience emotional discomfort or distress while reflecting on personal experiences during the program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline prfq scores after completion of intervention and at 3 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline prfq scores after completion of intervention and at 3 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Parent-Child Relationship Quality will be measured by Parent Child Interaction Teaching Scale (PCITS).
Secondary study objectives
Child Development, measured by Ages and Stages Questionnaire - 3rd Edition
Parental Reflective Function will be measured by Parental Reflective Function Questionnaire (PRFQ).
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention groupExperimental Treatment1 Intervention
* A quasi-experimental design was selected to more closely approximate service delivery models in agencies that do not typically employ control groups.
* Given promising findings (from seven ATTACH™ pilot studies), a randomized controlled trial design, even employing wait-list controls was deemed unacceptable and even unethical by patients, health care professionals and health system administrators in engagement activities surrounding the preparation of this proposal.
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Who is running the clinical trial?
University of CalgaryLead Sponsor
811 Previous Clinical Trials
889,276 Total Patients Enrolled
Nicole Letourneau, PhD RN FCAHSPrincipal InvestigatorUniversity of Calgary
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to join a 10-12 week parent training program for an hour each week.I agree to bring a co-parent to 2-3 sessions if possible.I am a parent of a child who is between birth and 32 months old.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.