Efficacy of IMPACT in Infant Siblings of Children With ASD
NCT ID: NCT03274622
Last Updated: 2019-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
97 participants
INTERVENTIONAL
2016-02-16
2019-08-30
Brief Summary
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Detailed Description
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1. Compared to the BAU Control, children assigned to the ImPACT group will show (a) more growth on pivotal skills and language level, and (b) a lesser degree of ASD symptomatology and language delay.
2. Pretreatment, cumulative-risk level will statistically interact with (i.e., moderate) treatment assignment to predict children's (a) change in pivotal skills and language, and (b) severity of autism symptoms and language delay.
3. Compared to the BAU Control, parents in ImPACT will have more optimal parenting stress and parenting efficacy, at least in parents with average or below average depressive symptoms prior to treatment (i.e., depressive symptoms will moderate the effect of ImPACT on parental stress and parenting efficacy).
4. The effect that ImPACT has on growth of pivotal skills and language will be mediated by parents' frequency and fidelity of use of ImPACT strategies at immediate post-treatment.
5. The effect of ImPACT on degree of children's language delay and ASD symptomatology at 6 months post-treatment will be mediated by their pivotal skill level at 3 months post-treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Impact Parent Training
Parents receive 22 1.5-hour sessions with a Speech Language pathologist coaching them in the implementation of the Impact intervention
Impact Parent Training
No Impact
No parent coaching is provided
No Impact
Interventions
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Impact Parent Training
No Impact
Eligibility Criteria
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Inclusion Criteria
1. Age: 11 months, 15 days to 18 months, 15 days
2. Older biological sibling: Must have a diagnosis of Autism from UW or VU, which is confirmed via record review. If the older sibling was not diagnosed at UW or VU, then a diagnostic appointment must be made for the older sibling at the corresponding institution in order to confirm the diagnosis of ASD. Half-siblings are ok.
3. Vision - WNL corrected
4. Hearing - WNL corrected
5. Motor: The child must be able to sit independently while picking up objects and giving them to another person.
Exclusions:
No primary motor impairment. No feeding tubes. No other neurological or genetic conditions. Primary language exposure: The primary parent speak to the child using English 50% of the time, and process.
12 Months
18 Months
ALL
No
Sponsors
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National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
Vanderbilt University
OTHER
Responsible Party
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Paul Yoder
Professor
Principal Investigators
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Paul J. Yoder, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Locations
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Vanderbilt University
Nashville, Tennessee, United States
University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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140924
Identifier Type: -
Identifier Source: org_study_id
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