Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)

Study Overview
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Brief Summary
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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 NDBI 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
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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 NDBI 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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Early Achievements- Parent Coaching Intervention


Participation Criteria
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Eligibility Criteria
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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 KKI-Center for Autism and Related Disorders(CARD) site (Baltimore; Odenton). Receiving >15 hours of treatment per week at enrollment Child lives in foster care. Caregiver refusing to wear a mask during visits

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 33 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telehealth Parent Coaching (TC)<br>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. | Behavioral: Early Achievements- Parent Coaching Intervention<br>* Children, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles.<br>|
| Active Comparator: In-person Coaching(IPC)<br>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. | Behavioral: Early Achievements- Parent Coaching Intervention<br>* Children, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Duration of Joint Attention | 10 minute caregiver/child play samples will be coded using Adamson's engagement coding schema. The schema differentiates different levels of engagement. This data will be used to compare duration of engagement states at pre- and post-testing. | 12 weeks | 
| Parent Fidelity of Implementation | Parent fidelity of implementation will be coded from the parent-child interaction sample obtained within the home at baseline and post-intervention by trained (to reliability) research assistants blind to group membership and timing of sample. This form consists of 26-items, where each item is rated using a 3-point Likert-type scale. Items reflect the key elements of Natural Developmental Behavioral Interventions(NDBIs) (Bruinsma, 2020), which have been assessed in parent-implemented NDBI studies found to improve child social-communication outcomes. Ratings are based on effectiveness (well-timed, variety, developmental appropriateness) and frequency/consistency. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Communication, Language, Engagement