Clinical trial NCT02945384: Broader Implementation of a Successful Dual-Generation Intervention in Partnership With Head Start of Lane County
Official title: Broader Implementation of a Successful Dual-Generation Intervention in Partnership With Head Start of Lane County
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: School Readiness
Keywords: family well-being
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 2800
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in brain function for selective attention: event-related potential (ERP) auditory selective attention paradigm (children and adults)
timeFrame: 3-6 months
measure: Changes in stress physiology: respiratory sinus arrhythmia (parasympathetic nervous system function) and pre-ejection period (sympathetic nervous system function)
timeFrame: 3-6 months
measure: Changes in child school performance: Head Start Teaching Strategies Gold assessments
timeFrame: 3-6 months
measure: Changes in child behavior for cognition: language (Clinical Evaluation of Language Fundamentals-Preschool: 2nd Ed.), IQ (Stanford-Binet Intelligence Scales-5th Ed.), executive function (Snack Delay, Shape School, Noisy Book)
timeFrame: 3-6 months
measure: Changes in brain function for self-regulation: event-related potential (ERP) stop-signal task paradigm (adults only)
timeFrame: 3-6 months
Secondary outcomes:
measure: Changes in child social behavior: Preschool and Kindergarten Behavior Scale - 2nd Ed.
timeFrame: 3-6 months
measure: Changes in parenting behavior: videotaped parent-child interactions coded for parent language behavior using Systematic Analysis of Language Transcripts-8
timeFrame: 3-6 months
measure: Changes in parenting stress: Parenting Stress Index
timeFrame: 3-6 months
measure: Changes in home environment: Confusion, Hubbub, and Order Scale (CHAOS)
timeFrame: 3-6 months
measure: Changes in adult health: systolic and diastolic blood pressure
timeFrame: 3-18 months
measure: Changes in family well-being: Head Start Family Partnership Plan (FPP): Assessment of Strengths, Capabilities, & Needs
timeFrame: 3-18 months
measure: Changes in home environment: Tayside Children's Sleep Questionnaire
timeFrame: 3-6 months
measure: Changes in adult health: blood spot biomarkers of immune function
timeFrame: 3-18 months
measure: Changes in adult health: blood spot biomarkers metabolic function
timeFrame: 3-18 months
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Eric Pakulak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.