Comparative Efficacy of Self-directed & Therapist-assisted Telehealth Parent Training Intervention for Children With ASD

NCT02721381 | Terminated Results

• 1 other identifier: R40MC27704
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The specific objectives of this project are to conduct a randomized control trial to examine the effect of a novel, telehealth parent training intervention for children with autism spectrum disorder (ASD), ImPACT Online, on parent and child outcomes. The investigators will compare the benefits of the self-directed and therapist-assisted delivery formats, and examine moderators and mediators of treatment outcomes. The investigators anticipate that both the self-directed and therapist-assisted models of ImPACT Online will be effective methods for teaching parents to use evidence-based intervention strategies and for increasing parent self-efficacy compared to a web-based information control group. Participants will be randomly assigned to one of three groups. One-third of participants will be in the therapist-assisted group; one-third will be in the self-directed group; and one-third will be in a web-based information control group.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Parent training; Telehealth; RCT

Outcome Measures

Primary Outcomes (6)

• Project ImPACT Intervention Fidelity Checklist

  Parents' use of the intervention strategies with their child is measured during a parent-child interaction in the home using the Project ImPACT Intervention Fidelity Checklist (Ingersoll \& Dvortcsak, 2019). Parents are asked to (1) play with their child for 10 minutes with a standard set of toys; and (2) have a small snack or meal with their child for 10 minutes. Parents are instructed to interact with their child as they typically would during both activities. Coders rated the parents' use of each of the five Project ImPACT intervention strategies on a scale of 1 ("does not implement the strategy, or almost all attempts to use the strategy are incorrect.") to 5 ("implements the strategy effectively throughout the session"). Scores for each strategy were averaged to form an overall fidelity rating for each activity. Fidelity ratings for each activity were averaged to form the parent fidelity variable.

  Post-treatment (6 months)

• Project ImPACT Intervention Fidelity Checklist

  Parents' use of the intervention strategies with their child is measured during a parent-child interaction in the home using the Project ImPACT Intervention Fidelity Checklist (Ingersoll \& Dvortcsak, 2019). Parents are asked to (1) play with their child for 10 minutes with a standard set of toys; and (2) have a small snack or meal with their child for 10 minutes. Parents are instructed to interact with their child as they typically would during both activities. Coders rated the parents' use of each of the five Project ImPACT intervention strategies on a scale of 1 ("does not implement the strategy, or almost all attempts to use the strategy are incorrect.") to 5 ("implements the strategy effectively throughout the session"). Scores for each strategy were averaged to form an overall fidelity rating for each activity. Fidelity ratings for each activity were averaged to form the parent fidelity variable.

  Follow up (9 months)

• Parent Sense of Competence (PSOC)

  The PSOC measures the extent to which parents believe they have the skills and knowledge needed to be good parents (efficacy) and their perceptions regarding the value of parenthood (satisfaction). Parents rated 17 items from 1 ("Strongly disagree") to 6 ("Strongly agree"). Items are summed, with higher scores indicative of higher parenting self-efficacy. Scores can range from 17 to 102, with higher scores indicative of greater self-efficacy

  Post-Treatment (6 months)

• Parent Sense of Competence (PSOC)

  The PSOC measures the extent to which parents believe they have the skills and knowledge needed to be good parents (efficacy) and their perceptions regarding the value of parenthood (satisfaction). Parents rated 17 items from 1 ("Strongly disagree") to 6 ("Strongly agree"). Items are summed, scores can range from 17 to 102, with higher scores indicative of higher parenting self-efficacy.

  Follow up (9 months)

• Weighted Frequency of Intentional Communication

  Children's use of intentional communication is scored from a parent-child interaction during play and snack using a modified version of the Weighted Frequency of Intentional Communication (WFIC) coding scheme (Yoder et al., 2021a), which quantifies the maturity of the form and frequency of intentional communication in young children with social communication delays. Coders transcribed and coded all non-imitated communicative utterances, including gestures, contingent vocalizations, single-words, simple phrases, and sentences. Each utterance was weighted (1-4) based on its complexity. Utterances are summed to produce a weighted frequency. Weighted frequency was were converted to a rate per minute by dividing the score by the length of the video. Values were log transformed to improve normality of distribution. Values ranged from -1.30 to 1.57 with higher values indicated higher weighted frequency of intentional communication. Means are adjusted for their T1 measure.

  Post-treatment (6 months)

• Child Expressive Language Ability

  Equally weighted composite score of child expressive language ability derived from MacArthur Bates Communicative Development Inventory (MB-CDI), Mullen Scales of Early Learning (MSEL) Expressive Language raw score, and Vineland Adaptive Behavior Scales (VABS) Expressive Language raw score. Measures were z-score transformed and averaged. Z-score of 0 represents mean for the participants. Positive z-score represent a better outcome.

  Follow up (9 months)

Secondary Outcomes (5)

• Family Impact Questionnaire

  Post-Treatment (6 months)

• Parenting Stress Index-Short Form

  Post-Treatment (6 months)

• Mullen Scales of Early Learning

  Follow up (9 months)

• MacArthur-Bates Communicative Development Inventory

  Follow up (9 Months)

• Vineland Adaptive Behavior Scales, 2nd Edition

  Follow up (9 Months)

Other Outcomes (1)

• Program Engagement

  Post-treatment (6 months)

Study Arms (3)

Self-Directed Group

EXPERIMENTAL

Participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.

Behavioral: ImPACT Online

Therapist-Assisted Group

EXPERIMENTAL

Participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. Participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.

Behavioral: ImPACT Online

Web-Based Information Control Group

NO INTERVENTION

Participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for participant maturation as well as the potentially confounding effect of having access to autism-related information via the internet.

Interventions

ImPACT Online BEHAVIORAL

ImPACT Online is an interactive, web-based telehealth intervention that teaches parents to promote their child's social-communication skills during play and daily routines. The intervention content was adapted from Project ImPACT, a manualized parent training curriculum that uses a blend of developmental and naturalistic behavioral intervention techniques, including following the child's lead, imitating the child, using heightened animation, using simplified language around the child's focus of attention, environmental arrangement strategies, prompting, and natural reinforcement during child-directed activities. There is strong empirical support for the intervention techniques for increasing social communication in children, increasing parent fidelity, and child language skills.

Self-Directed Group; Therapist-Assisted Group

Eligibility Criteria

• Age: 18 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• a DSM-V-informed clinical diagnosis of Autism Spectrum Disorder based on the Autism Diagnostic Observation Schedule (ADOS)

You may not qualify if:

• history of significant brain injury, known neurological or genetic condition
• significant sensory or motor impairment
• major medical problems
• primary caregiver of child participant
• Proficient in English
• under 18 years

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Michigan State University Autism Lab

East Lansing, Michigan, 48824, United States

Location

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  PMID: 39233512 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Brooke Ingersoll
• Organization: Michigan State University

ingers19@msu.edu

517-930-2275

Study Officials

• Brooke Ingersoll, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 29, 2016
• Study Start: March 1, 2015
• Primary Completion: October 10, 2020
• Study Completion: October 10, 2020
• Last Updated: February 7, 2025
• Results First Posted: February 7, 2025

Record last verified: 2025-02

Locations

US (1)