NCT03274622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

3.5 years

First QC Date

August 17, 2017

Last Update Submit

September 30, 2019

Conditions

Autism Spectrum Disorder

Outcome Measures

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

    Change between baseline and 9 months after entry

Secondary Outcomes (6)

  • Growth in play

    Change from Baseline to 9 months after entry

  • Motor imitation

    Change from Baseline to 9 months after entry

  • Autism social affect symptomatology

    9 months after entry

  • Language delay

    9 months after entry

  • language level

    Change from baseline to 9 mos after treatment ends

  • +1 more secondary outcomes

Study Arms (2)

Impact Parent Training

EXPERIMENTAL

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

No Impact

PLACEBO COMPARATOR

No parent coaching is provided

Behavioral: No Impact

Interventions

Impact Parent TrainingBEHAVIORAL
Impact Parent Training
No ImpactBEHAVIORAL
No Impact

Eligibility Criteria

Age12 Months - 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Washington

Seattle, Washington, 98195-7920, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Paul J. Yoder, Ph.D.

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 17, 2017

First Posted

September 7, 2017

Study Start

February 16, 2016

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

October 2, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)