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

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Achievements- Parent Coaching Intervention
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Social Communication, Language, Engagement

Eligibility Criteria

18 Months - 33 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kennedy Krieger InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Telehealth Parent Coaching (TC)

In-person Coaching(IPC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 8, 2021
Last Updated
April 24, 2023
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
United States Department of Defense, Johns Hopkins Bloomberg School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT05176808
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
United States Department of Defense, Johns Hopkins Bloomberg School of Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Social Communication, Language, Engagement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
All participants will receive the same outcome battery of assessments. The individual evaluating the child and all coders will be blind to condition.
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telehealth Parent Coaching (TC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
In-person Coaching(IPC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Early Achievements- Parent Coaching Intervention
Intervention Description
Children, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles.
Primary Outcome Measure Information:
Title
Child Duration of Joint Attention
Description
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.
Time Frame
12 weeks
Title
Parent Fidelity of Implementation
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
33 Months
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Landa, PhD
Phone
443-923-7591
Email
landa@kennedykrieger.org
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Herman, MS
Phone
443-923-7591
Email
hermand@kennedykrieger.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Landa, PhD
Organizational Affiliation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Landa, PhD, CCC-SLP
Phone
443-923-7632
Email
landa@kennedykrieger.org
First Name & Middle Initial & Last Name & Degree
Dana Herman, MS
Phone
443-923-7591
Email
hermand@kennedykrieger.org
First Name & Middle Initial & Last Name & Degree
Rebecca Landa, PhD, CCC-SLP
First Name & Middle Initial & Last Name & Degree
Rachel Reetzke, PhD-CCC-SLP

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26922192
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.
Results Reference
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Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)

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