NCT02945384

Broader Implementation of a Successful Dual-Generation Intervention in Partnership With Head Start of Lane County

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,800 (estimated)
• Sponsor: University of Oregon · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Accepted

Summary

This project involves the development of a scaled-up model of a successful dual-generation intervention targeting attention, stress, and self-regulation in families attending Head Start, and improvements of outcome assessments of the intervention. The investigators hypothesize that families randomly assigned to receive the intervention, compared to families not receiving the intervention, will show improved brain function for attention and self-regulation and improved physiological function for stress regulation in both children and their parents, improvements in child school performance and cognition, and improvements in assessments of parent/family well being.

Detailed description

Based on basic research on the neuroplasticity of attention, stress, and family dynamics, the investigators developed a successful dual-generation intervention that targets attention, stress, and self-regulation. The intervention has been shown to improve brain function for attention, cognition, and behavior in preschool children in Head Start (HS) and also improves communication skills and reduces stress in parents. This project involves the development of a scaled-up model of this intervention working with with Head Start of Lane County (HSOLC). Goal 1: In partnership with HSOLC, the investigators have developed a scaled-up model of the intervention that is delivered by HS specialists and sustainable and replicable by other HS programs. This intervention is called Creating Connections: Strong Families, Strong Brains (CC). Goal 2: To characterize the degree to which CC improves distal outcomes related to parent/family well-being by assessing health and safety outcomes in parents and children, parental education, financial literacy and decision making, household chaos, and biomarkers of allostatic load related to health outcomes. Goal 3: To evaluate hypothesized mediating factors related to changes in family well-being, specifically changes in foundational systems (stress and self-regulation) by refining measures of family stress and self-regulation by assessing heart rate variability in parents and children and neurophysiological measures of self-regulation in parents. Children and parents at randomly assigned HSOLC sites will receive CC, and other HSOLC sites will deliver the regular HS curriculum. The investigators hypothesize that participation in CC will result in improved brain function for attention and self-regulation as well as improved physiological function for stress regulation in both children and their parents compared to families not receiving the intervention.

Conditions

• School Readiness

Interventions

Type	Name	Description
BEHAVIORAL	Creating Connections: Strong Families, Strong Brains	Dual-generation intervention

Timeline

• Start date: 2013-09-01
• Primary completion: 2018-06-01
• Completion: 2019-09-01
• First posted: 2016-10-26
• Last updated: 2022-09-14

Locations

1 site across 1 country: United States