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

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ClinicalTrials.gov Identifier: NCT02721381
Recruitment Status : Recruiting
First Posted : March 29, 2016
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
Brooke Ingersoll, Michigan State University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: ImPACT Online Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Efficacy of a Self-directed and Therapist-assisted Telehealth Parent Training Intervention for Children With ASD
Study Start Date : March 2015
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Self-Directed Group
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
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.

Experimental: Therapist-Assisted Group
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
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.

No Intervention: Web-Based Information Control Group
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.



Primary Outcome Measures :
  1. ImPACT Online Fidelity Change Scale [ Time Frame: Month 1, Month 5, & Month 8 ]
    Parent Treatment Fidelity

  2. Parent Sense of Competence Change Scale [ Time Frame: Month 1, Month 5, & Month 8 ]
    Parent Self-Efficacy

  3. Mullen Scales of Early Learning Change Score [ Time Frame: Month 1 & Month 8 ]
    Child verbal language-Expressive language raw score

  4. MacArthur-Bates Child Developmental Inventory Change Score [ Time Frame: Month 1 & Month 8 ]
    Child verbal language-# words understood and used

  5. Parent-child Interaction Change [ Time Frame: Month 1 & Month 8 ]
    Child verbal language- mean length of utterance (MLU)

  6. ImPACT Online electronic tracking system [ Time Frame: Month 5 ]
    Treatment adherence - % of program elements completed; number of logins

  7. Intervention Log Change [ Time Frame: Month 1 & Month 8 ]
    Treatment adherence - # of hours per week of intervention use

  8. Vineland Adaptive Behavior Scales Change Score [ Time Frame: Month 1, Month 5, & Month 8 ]
    Adaptive behavior - communication, social functioning, daily living skills



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 95 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • history of significant brain injury, known neurological or genetic condition
  • significant sensory or motor impairment
  • major medical problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721381


Contacts
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Contact: Brooke Ingersoll, PhD 517-4328412 ingers19@msu.edu
Contact: Kaylin Russell, BA 517-432-8031 autlab@msu.edu

Locations
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United States, Michigan
Michigan State University Autism Lab Recruiting
East Lansing, Michigan, United States, 48824
Contact: Brooke Ingersoll, PhD    517-432-8412    ingers19@msu.edu   
Contact: Julia Nauman, BA    517-432-8031    autlab@msu.edu   
Sponsors and Collaborators
Michigan State University
Investigators
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Principal Investigator: Brooke Ingersoll, PhD Michigan State University
Publications:
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Publishing; 2013.
National Research Council. Educating Children With Autism. Washington, DC: National Academy Press; 2001.
Hume K, Bellini S, Pratt C. The usage and perceived outcomes of early intervention and early childhood programs for young children with Autism Spectrum Disorder. Topics Early Child Spec Educ. 2005;25(4):195-207.
Kaiser AP, Hancock TB, Nietfeld JP. Early education and development: The effects of parent-implemented Enhanced Milieu Teaching on the social communication of children who have Autism. Early Educ Dev. 2010;11(4):423-446. doi:10.1207/s15566935eed1104.
Stahmer AC, Gist K. The effects of an accelerated parent education program on technique mastery and child outcome. J Posit Behav Interv. 2001;3(2):75-82. doi:10.1177/109830070100300203.
Symon JB. Expanding interventions for children with Autism: Parents as trainers. J Posit Behav Interv. 2005;7(3):159-173. doi:10.1177/10983007050070030501.
United States Department of Education, Office of Planning, Evaluation, and Policy Development. Evaluation of Evidence-Based Practices in Online Learning: A Meta-Analysis and Review of Online Learning Studies. Washington, DC; 2010.
Weingardt KR. The role of instructional design and technology in the dissemination of empirically supported, manual-based therapies. Clin Psychol Scienec Pract. 2004;11:2004.
File T. Computer and internet use in the United States: Population characteristics. Washington, DC: US Census Bureau; 2013.
Bureau USC. Statistical abstract of the United States: 2013. 2013.
Internet User Demographics. Pew Res Cent Internet Proj Surv January 9-12, 2014. 2014.
Association AT. What is telemedicine? 2013.
Gros DF, Morland LA, Greene CJ, et al. Delivery of evidence-based psychotherapy via video telehealth. J Psychopathol Behav Assess. 2013;35(4):506-521. doi:10.1007/s10862-013-9363-4.
Nieuwboer CC, Fukkink RG, Hermanns JMA. Online programs as tools to improve parenting: A meta-analytic review. Child Youth Serv Rev. 2013;35(11):1823-1829. doi:10.1016/j.childyouth.2013.08.008.
Gustke SS, Balch DC, West VL, Rogers LO. Patient satisfaction with telemedicine. Telemed Journal2. 2000;6(1):5-13.
Kaiser AP, Hemmeter ML, Ostrosky MM, Alpert CL, Hancock TB. The effects of group training and individual feedback on parent use of Milieu Teaching. Commun Disord Q. 1995;16(2):39-48. doi:10.1177/152574019501600206.
Howroyd C, Peeters T. Parent participation in early intervention with software-assited guidance from AutismPro. Good Autism Pract. 2007;8(2):31-36.
Jang J, Dixon DR, Tarbox J, Granpeesheh D, Kornack J, de Nocker Y. Randomized trial of an eLearning program for training family members of children with autism in the principles and procedures of applied behavior analysis. Res Autism Spectr Disord. 2012;6(2):852-856. doi:10.1016/j.rasd.2011.11.004.
Nefdt N, Koegel R, Singer G, Gerber M. The use of a self-directed learning program to provide introductory training in Pivotal Response Treatment to parents of children with Autism. J Posit Behav Interv. 2009;12(1):23-32. doi:10.1177/1098300709334796.

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Responsible Party: Brooke Ingersoll, Associate Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT02721381    
Other Study ID Numbers: R40MC27704
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021
Keywords provided by Brooke Ingersoll, Michigan State University:
Autism Spectrum Disorder
Parent training
Telehealth
RCT
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders