School ReadinessNCT02945384
Broader Implementation of a Successful Dual-Generation Intervention in Partnership With Head Start of Lane County
A study testing Creating Connections: Strong Families, Strong Brains in people with School Readiness, run by University of Oregon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- School Readiness
- What is being tested?
- Creating Connections: Strong Families, Strong Brains
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,800 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Student at Head Start of Lane County (child); parent of student at HSOLC (parent)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Creating Connections: Strong Families, Strong Brains
- Keywords
- family well-being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creating Connections: Strong Families, Strong BrainsBehavioural
Dual-generation intervention
| Study group | Role | What they receive |
|---|---|---|
| Creating Connections | Experimental | Dual-generation intervention: child component delivered in classroom setting, parent component delivered in small-group setting Receives: Behavioral: Creating Connections: Strong Families, Strong Brains |
| Head Start as usual | No intervention | Regular Head Start curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3-6 months
Changes in child school performance: Head Start Teaching Strategies Gold assessments
Measured: 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)
Measured: 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.
Measured: 3-6 months
Secondary outcomes (9)
Changes in child social behavior: Preschool and Kindergarten Behavior Scale - 2nd Ed.
Measured: 3-6 months
Changes in parenting behavior: videotaped parent-child interactions coded for parent language behavior using Systematic Analysis of Language Transcripts-8
Measured: 3-6 months
Changes in parenting stress: Parenting Stress Index
Measured: 3-6 months
Changes in home environment: Confusion, Hubbub, and Order Scale (CHAOS)
Measured: 3-6 months
Changes in adult health: systolic and diastolic blood pressure
Measured: 3-18 months
Changes in family well-being: Head Start Family Partnership Plan (FPP): Assessment of Strengths, Capabilities, & Needs
Measured: 3-18 months
Changes in home environment: Tayside Children's Sleep Questionnaire
Measured: 3-6 months
Changes in adult health: blood spot biomarkers of immune function
Immune function will be assessed via the following biomarkers: C-reactive protein, Epstein-Barr Virus antibodies, interleukin-6
Measured: 3-18 months
Changes in adult health: blood spot biomarkers metabolic function
Metabolic function will be assessed via the following biomarkers: insulin, glycosylated hemoglobin (hemoglobin A1c) lipoprotein(a)
Measured: 3-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startSep 2013
- Primary completionJun 2018
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for School ReadinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Pakulak, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945384
- Sponsor's protocol ID
- 03172011.022
- Status last verified
- Apr 2019
- First submitted
- 24 Jun 2016
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23818591
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Broader Implementation of a Successful Dual-Generation Intervention in Partnership With Head Start of Lane County
- ClinicalTrials.gov ID
- NCT02945384
- Acronym / sponsor ID
- 03172011.022
- Conditions
- School Readiness
- Keywords
- family well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creating Connections | Experimental | Behavioral: Creating Connections: Strong Families, Strong BrainsDual-generation intervention: child component delivered in classroom setting, parent component delivered in small-group setting |
| Head Start as usual | No intervention | –Regular Head Start curriculum |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Student at Head Start of Lane County (child); parent of student at HSOLC (parent)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creating Connections: Strong Families, Strong BrainsDual-generation intervention | Behavioural | Creating Connections |
Primary outcome
Changes in brain function for selective attention: event-related potential (ERP) auditory selective attention paradigm (children and adults)
Time frame: 3-6 months
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.
Changes in stress physiology: respiratory sinus arrhythmia (parasympathetic nervous system function) and pre-ejection period (sympathetic nervous system function)
Time frame: 3-6 months
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.
Changes in child school performance: Head Start Teaching Strategies Gold assessments
Time frame: 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)
Time frame: 3-6 months
Changes in brain function for self-regulation: event-related potential (ERP) stop-signal task paradigm (adults only)
Time frame: 3-6 months
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.
9 secondary outcomes
Changes in child social behavior: Preschool and Kindergarten Behavior Scale - 2nd Ed.
Time frame: 3-6 months
Changes in parenting behavior: videotaped parent-child interactions coded for parent language behavior using Systematic Analysis of Language Transcripts-8
Time frame: 3-6 months
Changes in parenting stress: Parenting Stress Index
Time frame: 3-6 months
Changes in home environment: Confusion, Hubbub, and Order Scale (CHAOS)
Time frame: 3-6 months
Changes in adult health: systolic and diastolic blood pressure
Time frame: 3-18 months
Changes in family well-being: Head Start Family Partnership Plan (FPP): Assessment of Strengths, Capabilities, & Needs
Time frame: 3-18 months
Changes in home environment: Tayside Children's Sleep Questionnaire
Time frame: 3-6 months
Changes in adult health: blood spot biomarkers of immune function
Time frame: 3-18 months
Changes in adult health: blood spot biomarkers metabolic function
Time frame: 3-18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 23818591Neville 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Pakulak, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creating Connections: Strong Families, Strong Brains in people with School Readiness, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in brain function for selective attention: event-related potential (ERP) auditory selective attention paradigm (children and adults) (time frame: 3-6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02945384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.