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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
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Paul Yoder, Vanderbilt University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Impact Parent Training Behavioral: No Impact Not Applicable

Detailed Description:

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:

  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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  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

  5. 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

  6. 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



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Ages Eligible for Study:   12 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Younger sibling of a child with ASD -

  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.


Information from the National Library of Medicine

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


Contacts
Contact: Catherine Bush, M.A.CCC SLP 615/322-5127 catherine.t.bush@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Recruiting
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    stonew@uw.edu   
Principal Investigator: Wendy Stone, Ph.D.         
Sponsors and Collaborators
Vanderbilt University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Paul J. Yoder, Ph.D. Vanderbilt University

Responsible Party: Paul Yoder, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT03274622     History of Changes
Other Study ID Numbers: 140924
1R01DC013767-01 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders