Parent Telehealth Intervention for Children With Autism

NCT ID: NCT04501588

Last Updated: 2022-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-06

Study Completion Date

2021-11-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder Autism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessors who score/code the parent-child interaction are blind to condition

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Responsive training with no video feedback

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Responsive training with video feedback

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Responsive training with video feedback

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Responsive training with no video feedback

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Responsive training with no video feedback

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

Intervention Type BEHAVIORAL

Responsive training with video feedback

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

No Video Feedback Video Feedback

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

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.
Minimum Eligible Age

18 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Megan Roberts

Associate Professor of Communication Sciences and Disorders

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwestern University

Evanston, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25733749 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU00201708

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.