Efficacy of IMPACT in Infant Siblings of Children With ASD (IMPACT)
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|ClinicalTrials.gov Identifier: NCT03274622|
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : September 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Impact Parent Training Behavioral: No Impact||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||The assessors and coders are blind to treatment assignment. This will be achieved by using different people to conduct the treatment vs assessment and coding. Additionally, these different staff members have offices on different floors.|
|Official Title:||Efficacy of Parent-implemented Treatment in Infant Siblings of Children With Autism Spectrum Disorder (ASD)|
|Actual Study Start Date :||February 16, 2016|
|Estimated Primary Completion Date :||August 30, 2019|
|Estimated Study Completion Date :||August 30, 2019|
Experimental: Impact Parent Training
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
Placebo Comparator: No Impact
No parent coaching is provided
Behavioral: No Impact
- Growth in communication [ Time Frame: Change between baseline and 9 months after entry ]weighted frequency of intentional communication from the Communication and Symbolic Behavior Scale, high is good range is 0 - 400
- Growth in play [ Time Frame: Change from Baseline to 9 months after entry ]raw scores from Developmental Play Assessment, high is good, range is 0 to 50
- Motor imitation [ Time Frame: Change from Baseline to 9 months after entry ]raw scores from the Structured Social Imitation Scale, high is good, range 0 - 50
- Autism social affect symptomatology [ Time Frame: 9 months after entry ]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
- Language delay [ Time Frame: 9 months after entry ]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
- language level [ Time Frame: Change from baseline to 9 mos after treatment ends ]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
- parent implementation of ImPACT treatment [ Time Frame: change from baseline to immediately post-treatment ]fidelity of treatment of aspects of ImPACT treatment from PCS and PCFP
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274622
|Contact: Catherine Bush, M.A.CCC SLPfirstname.lastname@example.org|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator: Paul J. Yoder, Ph.D.|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98195-7920|
|Contact: Wendy Stone, Ph.D. 206-685-2821 email@example.com|
|Principal Investigator: Wendy Stone, Ph.D.|
|Principal Investigator:||Paul J. Yoder, Ph.D.||Vanderbilt University|