BridgeMD
New treatment option for Autism Spectrum Disorder
Official title Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)
ClinicalTrials.gov ID: NCT05176808
What this study is testing
- What it's testing
- The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD or social communication delays by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with either a social communication delay or ASD.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 42
You may be able to join if
- 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...
- Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)( criteria for ASD)
- ASD diagnosis by clinician (clinical best estimate) by study team clinical research experts
- Meeting study criteria for social communication delay based on:
You likely can't join if
- Having a primary language other than English
- Family lives \>40 miles from a Kennedy Krieger Institute-Center for Autism Services, Sciences, and Innovation (CASSI) site.
- Child lives in foster care.
See the full eligibility criteria
- 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),
- Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)( criteria for ASD)
- ASD diagnosis by clinician (clinical best estimate) by study team clinical research experts
- Meeting study criteria for social communication delay based on:
- Scoring a T score of \ 50 (Visual Reception and Fine Motor subscales averaged) AND Visual reception \> 12 months
- Nonverbal developmental quotient (DQ) of \> 63 based on the Visual Reception and Fine Motor subscales
- Gestational age of 36-42 weeks;
- Birth weight of \> 2,500 grams;
- Absence of identifiable neurological (e.g., epilepsy), genetic (e.g., Down syndrome, fragile X, tuberose sclerosis, neurofibromatosis) or severe sensory- motor (e.g., cerebral palsy) conditions.
- Able to walk independently.
- Children must produce at least three different types of intentional directed (with eye contact or pairing vocalization and gesture) nonverbal or verbal communicative acts per day, with clear and specific examples, per...
- Having a primary language other than English
- Family lives \>40 miles from a Kennedy Krieger Institute-Center for Autism Services, Sciences, and Innovation (CASSI) site.
- Child lives in foster care.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 months to 42 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.