Parent Telehealth Intervention for Children With Autism

NCT04501588 | Completed Phase 2

• 1 other identifier: STU00201708
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Autism

Keywords

autism; parent intervention; parent coaching; early intervention; parent-mediated intervention

Outcome Measures

Primary Outcomes (1)

• 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).

  Two months after the start of the study

Secondary Outcomes (1)

• MacArthur-Bates Communicative Development Inventory (MCDI) (Child)

  Two months after the start of the study

Study Arms (4)

Parent Learning Style 1

EXPERIMENTAL

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

Parent Learning Style 2

EXPERIMENTAL

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

Learning Style 1 (Parent)

ACTIVE COMPARATOR

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

Learning Style 2 (Parent)

ACTIVE COMPARATOR

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

Interventions

Responsive training with no video feedback BEHAVIORAL

Parents will receive responsive training, but will not watch themselves on video to reflect on their strategy use.

Also known as: No Video Feedback

Learning Style 2 (Parent); Parent Learning Style 1

Responsive training with video feedback BEHAVIORAL

Parents will receive responsive training and watch themselves on video to reflect on their strategy use.

Also known as: Video Feedback

Learning Style 1 (Parent); Parent Learning Style 2

Eligibility Criteria

• Age: 18 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• \- Biological Mother

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

Location

Related Publications (1)

• 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.

  PMID: 25733749 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors who score/code the parent-child interaction are blind to condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Communication Sciences and Disorders

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: March 6, 2020
• Primary Completion: September 2, 2021
• Study Completion: November 24, 2021
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)