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Behavioral Intervention

Telehealth Parent Coaching for Autism

N/A

Recruiting

Led By Rebecca Landa, PhD

Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to walk independently

Meeting study criteria for ASD based on Autism Diagnostic Observation Schedule (ADOS) criteria for mild-to-moderate concern or greater (for children between 18 and 30 months) or algorithm cut-offs for ASD or autism (31-33 months)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial is testing whether coaching parents of toddlers with ASD over telehealth is non-inferior to in-person coaching for the treatment of core social-communication symptoms.

Who is the study for?

This trial is for young children aged 18-33 months with mild-to-moderate Autism Spectrum Disorder (ASD), as confirmed by specific diagnostic tools. They should not have other neurological, genetic, or severe sensory-motor conditions and must be able to walk and communicate intentionally. The family must speak English, live within 30 miles of the study center, and not receive more than 15 hours of treatment per week.Check my eligibility

What is being tested?

The study tests if parent coaching for ASD via telehealth is just as effective as in-person coaching. It focuses on improving core social-communication skills in toddlers through a method called Early Achievements-Parent Coaching Intervention delivered remotely.See study design

What are the potential side effects?

Since this intervention involves behavioral therapy rather than medication, traditional side effects are not expected. However, there may be indirect effects such as frustration or fatigue during adjustment to new routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk on my own without help.

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My child meets the criteria for ASD based on ADOS.

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I do not have conditions like epilepsy, Down syndrome, or cerebral palsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Child Duration of Joint Attention

Parent Fidelity of Implementation

Trial Design

2Treatment groups

Active Control

Group I: In-person Coaching(IPC)Active Control1 Intervention

A family-centered, collaborative coaching approach, Practice-Based Coaching (Snyder et al., 2015), will be used. Coaches will use an NDBI coaching curriculum to support parents in targeting child social-communication skills during interactions with their toddlers with ASD. The duration of the coaching period is12 weeks with sessions 2 times per week. Parents will be coached to implement NDBI strategies during daily routines with their young child with ASD following the coach and parent NDBI manuals developed in the Landa lab. Coaching will be delivered in families' homes by trained study coaches to support parent implementation of NDBI strategies during daily life activities with their toddler with ASD.

Group II: Telehealth Parent Coaching (TC)Active Control1 Intervention

A family-centered, collaborative coaching approach, Practice-Based Coaching (Snyder et al., 2015), will be used. Coaches will use an NDBI coaching curriculum to support parents in targeting the child social-communication skills during interactions with their toddlers with ASD. The duration of the coaching period is 12 weeks with 2 sessions per week. Parents will be coached to implement NDBI strategies during daily routines with their young child with ASD following the coach and parent NDBI manuals developed in the Landa lab. Trained study coaches will join families in their homes remotely via Kennedy Krieger Institute's secure Zoom password-protected account to provide coaching.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor

88 Previous Clinical Trials

24,748 Total Patients Enrolled

15 Trials studying Autism Spectrum Disorder

3,291 Patients Enrolled for Autism Spectrum Disorder

United States Department of DefenseFED

864 Previous Clinical Trials

327,411 Total Patients Enrolled

18 Trials studying Autism Spectrum Disorder

1,552 Patients Enrolled for Autism Spectrum Disorder

Johns Hopkins Bloomberg School of Public HealthOTHER

410 Previous Clinical Trials

2,106,742 Total Patients Enrolled

Media Library

Early Achievements- Parent Coaching Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05176808 — N/A

Autism Spectrum Disorder Research Study Groups: In-person Coaching(IPC), Telehealth Parent Coaching (TC)

Autism Spectrum Disorder Clinical Trial 2023: Early Achievements- Parent Coaching Intervention Highlights & Side Effects. Trial Name: NCT05176808 — N/A

Early Achievements- Parent Coaching Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05176808 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participation size of this experiment?

"Affirmative. Clinicaltrials.gov contains evidence suggesting that this medical experiment, first posted on February 7th 2022 and last updated March 29th 2022, is actively enrolling participants from 1 location with a goal of recruiting 188 patients in total."

Answered by AI

Are there any restrictions on who can participate in this clinical experiment?

"The criteria for enrollment in this trial mandates that patients have a diagnosis of autism spectrum disorder, and are between 18 months to 33 months old. The medical study has set out to recruit 188 participants."

Answered by AI

Are there still opportunities for participation in this clinical research endeavor?

"That is correct. As per clinicaltrials.gov, which was last updated on March 29th 2022, this medical experiment is actively enrolling patients and searching for 188 individuals at a single trial site. The study initially went live on February 7th 2022."

Answered by AI

Is this experiment open to those participants aged 50 or over?

"This clinical trial is restricted to patients between 18 and 33 months of age. For those who do not meet this criteria, there are 214 trials specifically for individuals under the age of 18 and 41 studies targeting seniors over 65 years old."

Answered by AI

Recent research and studies

Journal of Autism and Developmental DisordersJournal

Comparison of a Self-directed and Therapist-assisted Telehealth Parent-mediated Intervention for Children with ASD: A Pilot RCT

Ingersoll, Brooke, Allison L. Wainer, Natalie I. Berger, Katherine E. Pickard, and Nicole Bonter. 2016. “Comparison of a Self-directed and Therapist-assisted Telehealth Parent-mediated Intervention for Children with ASD: A Pilot RCT”. Journal of Autism and Developmental Disorders. Springer Science and Business Media LLC. doi:10.1007/s10803-016-2755-z.

clinicaltrials.govStudy

Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)

2022. "Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05176808.

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