Telehealth Parent-Implemented Intervention to Improve Social- Communication Outcomes in Young Children With ASD

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 3
Healthy Volunteers: f
View:

• 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 \<35 on Expressive Language and/or Receptive Language subscales, Nonverbal developmental quotient 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 parent report in the Eligibility Interview.

Locations
United States
Maryland
Kennedy Krieger Institute
RECRUITING
Baltimore
Contact Information
Primary
Rebecca Landa, PhD
landa@kennedykrieger.org
443-923-7591
Backup
Rachel Reetzke, PhD
reetzke@kennedykrieger.org
443-923-7395
Time Frame
Start Date: 2022-02-07
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 188
Treatments
Active_comparator: Telehealth Parent Coaching (TC)
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 or social communication delays. The duration of the coaching period is 8-12 weeks with 2 sessions per week. Parents will be coached to implement NDBI strategies during daily routines with their young child with ASD or social communication delays 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.
Active_comparator: In-person Coaching(IPC)
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 or social communication delays. The duration of the coaching period is 8-12 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 or social communication delays.
Authors
Rachel Reetzke
Sponsors
Collaborators: Johns Hopkins Bloomberg School of Public Health, United States Department of Defense
Leads: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

This content was sourced from clinicaltrials.gov