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Behavioral Intervention
Parent Coaching Intervention for Autism Spectrum Disorder
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
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)
Nonverbal developmental quotient (DQ) of > 63 based on the Visual Reception and Fine Motor subscales
Must not have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up12 weeks
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Autism Spectrum Disorder
- Autism
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You do not have epilepsy, genetic disorders like Down syndrome or fragile X syndrome, or severe sensory-motor conditions like cerebral palsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
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
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 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.
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Who is running the clinical trial?
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have epilepsy, genetic disorders like Down syndrome or fragile X syndrome, or severe sensory-motor conditions like 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.
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
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