NCT04853888 ATTACH™ Program: Promoting Vulnerable Children's Health at Scale
| NCT ID | NCT04853888 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Parent-Child Relations |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2024-08-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * parents with children between birth and 32 months of age (based on selection of age-appropriate tools for assessing children's health and development) * parents agree to participate in the ATTACH™ program consisting of 10-12 weeks of one-hour per week parent training sessions * parents agreed to bring a co-parent for 2-3 of the 10 sessions (when possible) * parents agree to the dried blood sample collection from themselves and their children (in Calgary agencies) Exclusion Criteria: \-