Efficacy of IMPACT in Infant Siblings of Children With ASD

Study Overview
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Brief Summary
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Over a 5 year period infant and baby siblings of children with autism spectrum disorders (ASD) will be recruited to this study and will be randomized into 2 groups. Parents of the intervention group will receive 12 weeks of coaching in how to implement this intervention. Parents randomized to the control group will not receive intervention coaching. Both groups will attend a series of clinic appointments for data collection that occur at 3 month intervals over a 9 month period.

Detailed Description
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This two-site randomized controlled trail (RCT) will include a sample of 80 siblings of children with ASD (Sibs-ASD) (11 months, 15 days to 18 months, 15 days) who are stratified on initial cumulative-risk status for communication disorder and then randomly assigned to Ingersoll's Improving Parents As Communication Teachers (ImPACT; Ingersoll & Dvortcsak, 2010) treatment or to a business-as-usual (BAU) control condition. The following hypotheses will be tested: 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. 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. 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). 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. 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.

Official Title
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Efficacy of Parent-implemented Treatment in Infant Siblings of Children With Autism Spectrum Disorder (ASD)

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Impact Parent Training
* Behavioral: No Impact


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Younger sibling of a child with ASD - Age: 11 months, 15 days to 18 months, 15 days 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. Vision - WNL corrected Hearing - WNL corrected 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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Impact Parent Training<br>Parents receive 22 1.5-hour sessions with a Speech Language pathologist coaching them in the implementation of the Impact intervention | Behavioral: Impact Parent Training<br> <br> |
| Placebo Comparator: No Impact<br>No parent coaching is provided | Behavioral: No Impact<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth in communication | weighted frequency of intentional communication from the Communication and Symbolic Behavior Scale, high is good range is 0 - 400 | Change between baseline and 9 months after entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth in play | raw scores from Developmental Play Assessment, high is good, range is 0 to 50 | Change from Baseline to 9 months after entry | 
| Motor imitation | raw scores from the Structured Social Imitation Scale, high is good, range 0 - 50 | Change from Baseline to 9 months after entry | 
| Autism social affect symptomatology | average of z score from raw scores from Communication and Symbolic Behavior Scale and Autism Diagnositic Observation Schedule (reflected) if they are correlated > .4, after reflection high is good, -4 to 4 | 9 months after entry | 
| Language delay | average of z scores from standard scores or percentile rankings from MacAuthur Communication Development Index and Mullen Scale of Early Learning if they are correlated above .4, high is good, range is -4 to 4 | 9 months after entry | 
| language level | average of time 4-referenced z scores from raw scores from Communication and Symbolic Behavior Scales, Brief Observation of Social Communication Change, and MacArthur Communication Development Index if they are correlated above .4, High is good, -4 to 4 | Change from baseline to 9 mos after treatment ends | 
| parent implementation of ImPACT treatment | fidelity of treatment of aspects of ImPACT treatment from PCS and PCFP | change from baseline to immediately post-treatment |