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Parent Telehealth Intervention for Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04501588
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Megan Roberts, Northwestern University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Autism Behavioral: Responsive training with no video feedback Behavioral: Responsive training with video feedback Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Children will enroll in the study between 18-48 months of age and will be randomly assigned to either receive responsive training with video feedback or responsive training without video feedback.
Masking: Single (Outcomes Assessor)
Masking Description: Assessors who score/code the parent-child interaction are blind to condition
Primary Purpose: Treatment
Official Title: Parent Language Intervention for Autism
Actual Study Start Date : March 6, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


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.
Behavioral: Responsive training with no video feedback
Parents will receive responsive training, but will not watch themselves on video to reflect on their strategy use.
Other Name: No Video Feedback

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.
Behavioral: Responsive training with video feedback
Parents will receive responsive training and watch themselves on video to reflect on their strategy use.
Other Name: Video Feedback

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.
Behavioral: Responsive training with video feedback
Parents will receive responsive training and watch themselves on video to reflect on their strategy use.
Other Name: Video Feedback

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.
Behavioral: Responsive training with no video feedback
Parents will receive responsive training, but will not watch themselves on video to reflect on their strategy use.
Other Name: No Video Feedback




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04501588


Contacts
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Contact: Megan Y Roberts, PhD 8474913183 megan.y.roberts@northwestern.edu
Contact: Laura Sudec, MSW 847-491-3183 laura.sudec@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Megan Y Roberts, PhD    847-491-3183    megan.y.roberts@northwestern.edu   
Contact: Laura Sudec, MSW    8474913183    laura.sudec@northwestern.edu   
Principal Investigator: Megan Y Roberts, PhD         
Sponsors and Collaborators
Northwestern University
Publications:
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Responsible Party: Megan Roberts, Associate Professor of Communication Sciences and Disorders, Northwestern University
ClinicalTrials.gov Identifier: NCT04501588    
Other Study ID Numbers: STU00201708
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: N/A at this time

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Megan Roberts, Northwestern University:
autism
parent intervention
parent coaching
early intervention
parent-mediated intervention
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders