Clinical trial NCT03274622: Efficacy of IMPACT in Infant Siblings of Children With ASD
Official title: Efficacy of Parent-implemented Treatment in Infant Siblings of Children With Autism Spectrum Disorder (ASD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2017-09-07
Enrollment: 97
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Growth in communication
timeFrame: Change between baseline and 9 months after entry
Secondary outcomes:
measure: Growth in play
timeFrame: Change from Baseline to 9 months after entry
measure: Motor imitation
timeFrame: Change from Baseline to 9 months after entry
measure: Autism social affect symptomatology
timeFrame: 9 months after entry
measure: Language delay
timeFrame: 9 months after entry
measure: language level
timeFrame: Change from baseline to 9 mos after treatment ends
measure: parent implementation of ImPACT treatment
timeFrame: change from baseline to immediately post-treatment
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Vanderbilt University
name: Paul J. Yoder, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: