Study protocol for Attachment & Child Health (ATTACHTM) program: promoting vulnerable Children's health at scale.
Lubna Anis, Nicole Letourneau, Kharah M Ross...
https://pubmed.ncbi.nlm.nih.gov/35986306Actively Recruiting
Phase Not Applicable
All Genders
Healthy Volunteers
ID04853888
Attachment and Child Health (ATTACH™) Program: Promoting Vulnerable Children's Health at Scale
Led by University of Calgary · Updated on 2024-08-22
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the ATTACH™ parenting program designed to support families with preschool children affected by toxic stress, such as parental depression, addictions, domestic violence, and poverty. The program aims to improve the quality of parent-child relationships by enhancing parents' reflective function (RF), which is the ability to understand both their own and their child's thoughts and feelings. This function is important for secure attachment and healthy child development, including cognition, communication, and inflammation. The study also explores whether the program can be effectively delivered by trained community agency professionals rather than researchers, and investigates its impact on immune biomarkers linked to inflammation. The ATTACH™ program consists of 10 to 12 weekly one-hour parent training sessions. Parents participate with their children aged from birth up to 32 months and are encouraged to involve a co-parent in 2 to 3 of the sessions when possible. The program is delivered at community agencies and includes dried blood sample collection from parents and children at select locations. This study uses a quasi-experimental design without control groups to reflect real-world service delivery in community settings. Participants will be involved in pre- and post-program assessments of parent-child relationship quality, parental reflective function, and child development using standardized questionnaires and observation tools. Additional evaluation includes examining immune cell gene expression and DNA methylation markers. Health professionals' adherence to the program and their experiences with implementation are studied through interviews. Outcomes are measured immediately after the program and again three months later, with ongoing qualitative data collection to understand factors affecting routine program use in community settings.
CONDITIONS
Brief Title
ATTACH™ Program: Promoting Vulnerable Children's Health at Scale
Who Can Participate
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Parents with children between birth and 32 months old
- Parents agree to participate in the ATTACH™ program consisting of 10-12 weekly one-hour parent training sessions
- Parents agree to bring a co-parent for 2-3 of the sessions when possible
- Parents agree to dried blood sample collection from themselves and their children (in Calgary agencies)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 10 to 12 weeks
Participants engage in the ATTACH™ parenting program consisting of 10 to 12 weekly one-hour parent training sessions aimed at improving parent-child relationship quality and parental reflective function.
Weekly visits for 10 to 12 weeks
Follow-up
Duration - 3 months
Participants have assessments 3 months after completing the ATTACH™ program to evaluate sustained impacts on parent-child relationship quality, parental reflective function, and child development.
1 visit 3 months post-intervention
Trial Site Locations
Total: 1 location
1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Actively Recruiting
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Research Team
N
Nicole Letourneau, PhD RN FAAN
M
Martha Hart, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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