Efficacy of IMPACT in Infant Siblings of Children With ASD (IMPACT)

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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Impact Parent Training; Behavioral: No Impact

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
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Washington
    • Seattle, Washington, United States, 98195-7920
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Paul J. Yoder, Ph.D., Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2016
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (Actual): September 7, 2017

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 140924; 1R01DC013767-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No