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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Impact Parent Training
No Impact
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

12 Months - 18 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Impact Parent Training

No Impact

Arm Description

Parents receive 22 1.5-hour sessions with a Speech Language pathologist coaching them in the implementation of the Impact intervention

No parent coaching is provided

Outcomes

Primary Outcome Measures

Growth in communication
weighted frequency of intentional communication from the Communication and Symbolic Behavior Scale, high is good range is 0 - 400

Secondary Outcome Measures

Growth in play
raw scores from Developmental Play Assessment, high is good, range is 0 to 50
Motor imitation
raw scores from the Structured Social Imitation Scale, high is good, range 0 - 50
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
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
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
parent implementation of ImPACT treatment
fidelity of treatment of aspects of ImPACT treatment from PCS and PCFP

Full Information

First Posted
August 17, 2017
Last Updated
September 30, 2019
Sponsor
Vanderbilt University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT03274622
Brief Title
Efficacy of IMPACT in Infant Siblings of Children With ASD
Acronym
IMPACT
Official Title
Efficacy of Parent-implemented Treatment in Infant Siblings of Children With Autism Spectrum Disorder (ASD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 16, 2016 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Impact Parent Training
Arm Type
Experimental
Arm Description
Parents receive 22 1.5-hour sessions with a Speech Language pathologist coaching them in the implementation of the Impact intervention
Arm Title
No Impact
Arm Type
Placebo Comparator
Arm Description
No parent coaching is provided
Intervention Type
Behavioral
Intervention Name(s)
Impact Parent Training
Intervention Type
Behavioral
Intervention Name(s)
No Impact
Primary Outcome Measure Information:
Title
Growth in communication
Description
weighted frequency of intentional communication from the Communication and Symbolic Behavior Scale, high is good range is 0 - 400
Time Frame
Change between baseline and 9 months after entry
Secondary Outcome Measure Information:
Title
Growth in play
Description
raw scores from Developmental Play Assessment, high is good, range is 0 to 50
Time Frame
Change from Baseline to 9 months after entry
Title
Motor imitation
Description
raw scores from the Structured Social Imitation Scale, high is good, range 0 - 50
Time Frame
Change from Baseline to 9 months after entry
Title
Autism social affect symptomatology
Description
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
Time Frame
9 months after entry
Title
Language delay
Description
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
Time Frame
9 months after entry
Title
language level
Description
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
Time Frame
Change from baseline to 9 mos after treatment ends
Title
parent implementation of ImPACT treatment
Description
fidelity of treatment of aspects of ImPACT treatment from PCS and PCFP
Time Frame
change from baseline to immediately post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J. Yoder, Ph.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-7920
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of IMPACT in Infant Siblings of Children With ASD

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