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

NCT02945384 | Completed

• 1 other identifier: 03172011.022
• Study Type: interventional
• Target: 2,800
• Locations: 1 country
• Sites: 1

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.

Conditions

School Readiness

Keywords

family well-being

Outcome Measures

Primary Outcomes (5)

• Changes in brain function for selective attention: event-related potential (ERP) auditory selective attention paradigm (children and adults)

  To measure brain function for selective attention using ERPs, participants selectively attend to one of two simultaneously presented stories that differ in location (left/right), voice (male/female), and content. ERPs are recorded to identical 100 msec probes embedded in stories when attended and unattended, and the effects of selective attention are quantified by comparing the brain response to probes embedded in the attended story with the response to identical probes embedded in the unattended story.

  3-6 months

• Changes in stress physiology: respiratory sinus arrhythmia (parasympathetic nervous system function) and pre-ejection period (sympathetic nervous system function)

  RSA is an index of high-frequency beat-to-beat variability of the electrocardiogram (ECG) signal, while accounting for variability in respiration rate. PEP is the amount of time between depolarization of the left ventricle, seen in the ECG wave as the "Q" component directly preceding a heart beat, and subsequent ejection of blood through the ventricles, measured via the maximal rate of change in the impedance waveform of the subsequent "B" component. Baseline values of RSA and PEP will be acquired upon arrival to the lab during a five-minute neutral video of ocean scenes. Following this, RSA and PEP will be collected during two ERP paradigms measuring selective attention (children and adults) and self-regulation (adults only). After the tasks, physiology will be recorded during a final five-minute recovery period while a neutral video is shown.

  3-6 months

• Changes in child school performance: Head Start Teaching Strategies Gold assessments

  3-6 months

• 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)

  3-6 months

• Changes in brain function for self-regulation: event-related potential (ERP) stop-signal task paradigm (adults only)

  Brain function for self-regulation will be measured with an ERP variant of the stop-signal task with an added feedback component. Each trial begins with a fixation cross for 500 ms, followed by an arrow cue pointing either left or right for 500 ms (the "go signal"), a feedback stimulus presented 400-600 ms after a response and remaining on the screen for 100 ms, and finally a jittered intertrial interval of 2000 to 4000 ms. On 25% of trials, an auditory stop signal is played at a variable latency and adjusts trial-by-trial to appear 50 ms earlier following failed stops and 50 ms later after successful stops, while adjusting to maintain 50% response accuracy over blocks of eight stop trials. Shorter delay between cue and stop signal for successful stops indicates better inhibitory control. ERPs will be averaged to the onset of auditory stop signals, responses, and feedback stimuli.

  3-6 months

Secondary Outcomes (9)

• Changes in child social behavior: Preschool and Kindergarten Behavior Scale - 2nd Ed.

  3-6 months

• Changes in parenting behavior: videotaped parent-child interactions coded for parent language behavior using Systematic Analysis of Language Transcripts-8

  3-6 months

• Changes in parenting stress: Parenting Stress Index

  3-6 months

• Changes in home environment: Confusion, Hubbub, and Order Scale (CHAOS)

  3-6 months

• Changes in adult health: systolic and diastolic blood pressure

  3-18 months

Study Arms (2)

Creating Connections

EXPERIMENTAL

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

Behavioral: Creating Connections: Strong Families, Strong Brains

Head Start as usual

NO INTERVENTION

Regular Head Start curriculum

Interventions

Creating Connections: Strong Families, Strong Brains BEHAVIORAL

Dual-generation intervention

Creating Connections

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oregon: lead

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

• 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.

  PMID: 23818591 BACKGROUND

Study Officials

• Eric Pakulak, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: October 26, 2016
• Study Start: September 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2019
• Last Updated: September 14, 2022

Record last verified: 2019-04

Locations

US (1)