- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04501588
Parent Telehealth Intervention for Children With Autism
January 4, 2022 updated by: Megan Roberts, Northwestern University
Parent Language Intervention for Autism
As a result of the COVID-19 pandemic, telecoaching/telepractice models are of urgent importance.
Given this, parents in the study will receive parent coaching through weekly video calls.
To help us understand the best types of telecoaching, we will offer all participants responsive coaching, with half of the participants receiving an additional opportunity to reflect on their own use of language strategies with a therapist using video feedback and the other half receiving responsive coaching as usual, without video feedback.
This information is important in helping us to understand the best way to coach parents using a telepractice model so that parents implement the intervention at high fidelity.
Furthermore, we will aim to understand how parent learning style may also influence the implementation of these strategies.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Evanston, Illinois, United States, 60208
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 4 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Child inclusion criteria include:
- diagnosis of ASD or showing signs of ASD based on autism screening
- chronological age of less than 48 months
- a parent who is willing to learn intervention strategies
- English as the primary language spoken in the home
Parent inclusion criteria include:
- Biological Mother
Exclusion Criteria:
- Children or parents with additional impairments (e.g., blindness, deafness, genetic syndromes) will be excluded from the study.
- Fathers or caregivers other than the child's Mother will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Parent Learning Style 1
Mothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.
|
Parents will receive responsive training, but will not watch themselves on video to reflect on their strategy use.
Other Names:
|
|
EXPERIMENTAL: Parent Learning Style 2
Mothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.
|
Parents will receive responsive training and watch themselves on video to reflect on their strategy use.
Other Names:
|
|
ACTIVE_COMPARATOR: Learning Style 1 (Parent)
Mothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.
|
Parents will receive responsive training and watch themselves on video to reflect on their strategy use.
Other Names:
|
|
ACTIVE_COMPARATOR: Learning Style 2 (Parent)
Mothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.
|
Parents will receive responsive training, but will not watch themselves on video to reflect on their strategy use.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent Use of Language Support Strategies (Mother-child interaction)
Time Frame: Two months after the start of the study
|
Mother use of intervention strategies will be measured by transcribing and coding mother behaviors during 12-minute parent-child interactions, using a standard set of toys.
The primary dependent variable will be the amount of correct strategy used expressed as a percentage correct.
This is the percentage of child communication to which the adult responds correctly (i.e., contingently and within 5 seconds).
|
Two months after the start of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MacArthur-Bates Communicative Development Inventory (MCDI) (Child)
Time Frame: Two months after the start of the study
|
Parent report of child's expressive vocabulary and prelinguistic communication skills
|
Two months after the start of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 6, 2020
Primary Completion (ACTUAL)
September 2, 2021
Study Completion (ACTUAL)
November 24, 2021
Study Registration Dates
First Submitted
August 3, 2020
First Submitted That Met QC Criteria
August 3, 2020
First Posted (ACTUAL)
August 6, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 10, 2022
Last Update Submitted That Met QC Criteria
January 4, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00201708
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
N/A at this time
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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