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

NCT ID: NCT02945384

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2019-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Creating Connections

Dual-generation intervention: child component delivered in classroom setting, parent component delivered in small-group setting

Group Type: EXPERIMENTAL

Creating Connections: Strong Families, Strong Brains

Intervention Type: BEHAVIORAL

Dual-generation intervention

Head Start as usual

Regular Head Start curriculum

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Creating Connections: Strong Families, Strong Brains

Dual-generation intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oregon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Pakulak, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oregon

Locations

University of Oregon

Eugene, Oregon, United States

Countries

United States

References

Neville HJ, Stevens C, Pakulak E, Bell TA, Fanning J, Klein S, Isbell E. Family-based training program improves brain function, cognition, and behavior in lower socioeconomic status preschoolers. Proc Natl Acad Sci U S A. 2013 Jul 16;110(29):12138-43. doi: 10.1073/pnas.1304437110. Epub 2013 Jul 1.

Reference Type: BACKGROUND

PMID: 23818591 (View on PubMed)

Other Identifiers

03172011.022

Identifier Type: -

Identifier Source: org_study_id