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

University of Oregon logo

University of Oregon

Status

Completed

Conditions

School Readiness

Treatments

Behavioral: Creating Connections: Strong Families, Strong Brains

Study type

Interventional

Funder types

Other

Identifiers

NCT02945384
03172011.022

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,800 estimated patients

Sex

All

Ages

3 to 5 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Student at Head Start of Lane County (child); parent of student at HSOLC (parent)

Exclusion criteria

  • Not a native speaker of English or Spanish
  • does not have normal hearing, vision, physical, motor, and emotional development
  • has history of brain injury or disorder
  • currently taking medications that affect brain function

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2,800 participants in 2 patient groups

Creating Connections
Experimental group
Description:
Dual-generation intervention: child component delivered in classroom setting, parent component delivered in small-group setting
Treatment:
Behavioral: Creating Connections: Strong Families, Strong Brains
Head Start as usual
No Intervention group
Description:
Regular Head Start curriculum

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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