CClinicalTrials.gg
CompletedNCT03274622IMPACTUpdated Oct 2, 2019

Efficacy of IMPACT in Infant Siblings of Children With ASD

An interventional study of Impact Parent Training and No Impact in Autism Spectrum Disorder, sponsored by Vanderbilt University. Completed at 2 sites in United States. Open to participants aged 12 Months to 18 Months. Per ClinicalTrials.gov, last updated 2019-10-02.

Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
97
Allocation
Randomized
Ages
12 Months to 18 Months
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Autism Spectrum Disorder
03

Who can participate

Ages eligible
12 Months to 18 Months
Sexes eligible
All
Accepts healthy volunteers
No

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.

Exclusion criteria

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.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
97 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralImpact Parent Training
  • BehavioralNo Impact
05

What researchers measure

Primary outcomes

  1. Growth in communication

    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 outcomes

  1. Growth in play

    raw scores from Developmental Play Assessment, high is good, range is 0 to 50

    Time frame: Change from Baseline to 9 months after entry

  2. Motor imitation

    raw scores from the Structured Social Imitation Scale, high is good, range 0 - 50

    Time frame: Change from Baseline to 9 months after entry

  3. 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

    Time frame: 9 months after entry

  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

    Time frame: 9 months after entry

  5. 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

    Time frame: Change from baseline to 9 mos after treatment ends

  6. parent implementation of ImPACT treatment

    fidelity of treatment of aspects of ImPACT treatment from PCS and PCFP

    Time frame: change from baseline to immediately post-treatment

06

Study locations

2 sites
  • Vanderbilt University
    Nashville, Tennessee 37232, United States
  • University of Washington
    Seattle, Washington 98195-7920, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03274622
Lead sponsor
Vanderbilt University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Responsible party
Paul Yoder (Professor, Vanderbilt University) — Principal investigator
First posted
Sep 7, 2017
Start date
Feb 16, 2016
Primary completion
Aug 30, 2019
Completion
Aug 30, 2019
Last update
Oct 2, 2019

Study contacts

Paul J. Yoder, Ph.D.
principal investigator · Vanderbilt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion