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Parent Telehealth Intervention for Children With Autism

Primary Purpose

Autism Spectrum Disorder, Autism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Responsive training with no video feedback
Responsive training with video feedback
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism, parent intervention, parent coaching, early intervention, parent-mediated intervention

Eligibility Criteria

18 Months - 48 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Parent Learning Style 1

Parent Learning Style 2

Learning Style 1 (Parent)

Learning Style 2 (Parent)

Arm Description

Mothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.

Mothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.

Mothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.

Mothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.

Outcomes

Primary Outcome Measures

Parent Use of Language Support Strategies (Mother-child interaction)
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

MacArthur-Bates Communicative Development Inventory (MCDI) (Child)
Parent report of child's expressive vocabulary and prelinguistic communication skills

Full Information

First Posted
August 3, 2020
Last Updated
January 4, 2022
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04501588
Brief Title
Parent Telehealth Intervention for Children With Autism
Official Title
Parent Language Intervention for Autism
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
September 2, 2021 (Actual)
Study Completion Date
November 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism
Keywords
autism, parent intervention, parent coaching, early intervention, parent-mediated intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Assessors who score/code the parent-child interaction are blind to condition
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent Learning Style 1
Arm Type
Experimental
Arm Description
Mothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.
Arm Title
Parent Learning Style 2
Arm Type
Experimental
Arm Description
Mothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.
Arm Title
Learning Style 1 (Parent)
Arm Type
Active Comparator
Arm Description
Mothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.
Arm Title
Learning Style 2 (Parent)
Arm Type
Active Comparator
Arm Description
Mothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.
Intervention Type
Behavioral
Intervention Name(s)
Responsive training with no video feedback
Other Intervention Name(s)
No Video Feedback
Intervention Description
Parents will receive responsive training, but will not watch themselves on video to reflect on their strategy use.
Intervention Type
Behavioral
Intervention Name(s)
Responsive training with video feedback
Other Intervention Name(s)
Video Feedback
Intervention Description
Parents will receive responsive training and watch themselves on video to reflect on their strategy use.
Primary Outcome Measure Information:
Title
Parent Use of Language Support Strategies (Mother-child interaction)
Description
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).
Time Frame
Two months after the start of the study
Secondary Outcome Measure Information:
Title
MacArthur-Bates Communicative Development Inventory (MCDI) (Child)
Description
Parent report of child's expressive vocabulary and prelinguistic communication skills
Time Frame
Two months after the start of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
N/A at this time
Citations:
PubMed Identifier
25733749
Citation
Roberts MY, Kaiser AP. Early intervention for toddlers with language delays: a randomized controlled trial. Pediatrics. 2015 Apr;135(4):686-93. doi: 10.1542/peds.2014-2134. Epub 2015 Mar 2.
Results Reference
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Learn more about this trial

Parent Telehealth Intervention for Children With Autism

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