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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)
Must not have
Receiving >15 hours of treatment per week at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I can walk on my own without help.
Select...
My child meets the criteria for ASD based on ADOS.
Select...
I do not have conditions like epilepsy, Down syndrome, or cerebral palsy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently undergoing more than 15 hours of treatment per week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Child Duration of Joint Attention
Parent Fidelity of Implementation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 primary principal investigator's 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 primary principal investigator's lab.
Trained study coaches will join families in their homes remotely via Kennedy Krieger Institute's secure Zoom password-protected account to provide coaching.
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Who is running the clinical trial?
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
89 Previous Clinical Trials
24,675 Total Patients Enrolled
15 Trials studying Autism Spectrum Disorder
3,344 Patients Enrolled for Autism Spectrum Disorder
United States Department of DefenseFED
910 Previous Clinical Trials
333,543 Total Patients Enrolled
18 Trials studying Autism Spectrum Disorder
1,562 Patients Enrolled for Autism Spectrum Disorder
Johns Hopkins Bloomberg School of Public HealthOTHER
427 Previous Clinical Trials
2,133,514 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My caregiver will not wear a mask during visits.I have been diagnosed with Autism Spectrum Disorder by a clinician.My child meets the criteria for ASD based on ADOS.I can walk on my own without help.I am currently undergoing more than 15 hours of treatment per week.My primary language is not English.I do not have conditions like epilepsy, Down syndrome, or cerebral palsy.
Research Study Groups:
This trial has the following groups:- Group 1: In-person Coaching(IPC)
- Group 2: Telehealth Parent Coaching (TC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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