Clinical trial NCT05176808: Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)
Official title: Telehealth Parent-Implemented Intervention to Improve Social- Communication Outcomes in Young Children With ASD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Social Communication
Language
Engagement
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Johns Hopkins Bloomberg School of Public Health
First posted: 2022-01-04
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Upon confirmation of eligibility and completion of the baseline assessments, participants will be randomly assigned to the TC or IPC study condition. Randomization will be done in randomly permuted groups of different sizes to reduce predictability of treatment assignment, with one half of the parent-child dyads in each block assigned to the IPC arm and one half assigned to the TC condition.
Primary purpose: TREATMENT

Brief summary: The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD 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 ASD.

Detailed description: The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD 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 ASD. The secondary hypothesis is that feasibility (defined as parent fidelity) of TC is non-inferior to IPC. An exploratory objective is to guide clinical decision-making for telehealth implementation by examining the heterogeneity of treatment response across the two treatment arms. The investigators will test the hypothesis that baseline child behavioral dysregulation, active engagement, developmental quotient, and parent stress moderate child social-communication outcomes.

After completing eligibility testing, eligible children will be randomized into the TC or IPC condition. Each condition will involve twice weekly coaching sessions over 12 weeks. At the end of the twelve weeks, participants will be reassessed.

Eligibility criteria: Inclusion Criteria:

* Inclusion 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
  * 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 parent report in the Eligibility Interview.
  * Caregiver must conduct symptom screening prior to each research visit
  * Caregiver much wear a mask during visits

Exclusion Criteria:

* Having a primary language other than English
* Family lives \>30 miles from a Kennedy Krieger Institute-Center for Autism and Related Disorders(CARD) site.
* Receiving \>15 hours of treatment per week at enrollment
* Child lives in foster care.
* Caregiver refusing to wear a mask during visits

Primary outcomes:
measure: Child Duration of Joint Attention
timeFrame: 12 weeks
measure: Parent Fidelity of Implementation
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Rebecca Landa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingersoll B, Wainer AL, Berger NI, Pickard KE, Bonter N. Comparison of a Self-Directed and Therapist-Assisted Telehealth Parent-Mediated Intervention for Children with ASD: A Pilot RCT. J Autism Dev Disord. 2016 Jul;46(7):2275-84. doi: 10.1007/s10803-016-2755-z.