Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
NCT04853888

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

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

ATTACH™ is a psycho-educational parenting program, designed with community agencies serving families of preschoolers affected by toxic stress (e.g. parental depression, addictions, domestic violence, poverty) to bolster children's health and development. It focuses on improving parent-child relationship quality by targeting parents' reflective function (RF), i.e. the ability to better understand one's own and one's child's thoughts and feelings. RF is essential for high quality parent-child relationships and secure attachment, both tied to child development and health, especially cognition, communication and inflammation. ATTACH™ was implemented and tested in seven rapid-cycling pilot studies by researchers, guided by the IDEAS (Innovate, Develop, Evaluate, Adapt, Scale) Framework™, an innovative clinical trial approach. ATTACH™ significantly improved: (a) parent-child relationship quality and attachment, (b) parents' RF scores, and (c) children's cognitive and motor development. However, whether ATTACH™ continues to work with delivery by trained agency healthcare professionals rather than study researchers, in naturalistic, community settings remains to be seen. Small sample sizes also limited the ability to assess longer-term impacts and whether ATTACH™ is equally effective across patient populations. Further, another parenting intervention successfully reduced systemic inflammation in children exposed to toxic stress. Whether ATTACH™ impacts novel biomarkers of inflammation (i.e. immune cell gene expression and DNA methylation) is not known.

CONDITIONS

Official Title

ATTACH™ Program: Promoting Vulnerable Children's Health at Scale

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Parents with children between birth and 32 months of age
  • 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 at some locations
Not Eligible

You will not qualify if you...

  • None specified

AI-Screening

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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

CONTACT

M

Martha Hart, PhD

CONTACT

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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