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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02184390
Other study ID # 5R44MH086936
Secondary ID 5R44MH086936
Status Completed
Phase N/A
First received July 3, 2014
Last updated February 1, 2016
Start date May 2013
Est. completion date September 2015

Study information

Verified date February 2016
Source Center for Psychological Consultation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study will evaluate the efficacy and user satisfaction with a web-based interactive tutorial for caregivers of young children with autism designed to a) teach parents how to promote their child's development in the core deficit areas, b) help parents understand and improve challenging behaviors their child may demonstrate, and c) reduce caregiver stress through more effective interactions. It emphasizes everyday situations as opportunities for learning, including common home routines and contains videotaped illustrations of parents using the techniques taught in the home environment.


Description:

Autism is a neurodevelopmental disorder characterized by core deficits in social reciprocity, verbal and nonverbal communication, and behavior. Early detection and intervention has been shown to improve these core deficits, resulting in better long-term outcomes in language functioning, cognitive/developmental skills, and social and adaptive behavior. Despite the demonstrated benefits of effective intervention, few children receive these specialized services, due in part to critical resource barriers, such as the shortage of specialists trained to deliver them. The broad, long-term objective of this project is to improve outcomes for children with autism and their families by empowering caregivers with the knowledge and skills needed to effectively intervene directly with their children as part of their daily interactions and routines. By targeting those with the most invested in the child's success and the longest lasting influence on a child's long-term growth and development, we can help parents in several ways: a) teach parents how to promote their child's development in the core deficit areas seen in young children with autism spectrum disorders: social interaction, communication, play, and imitation; b) help parents understand and improve challenging behaviors their child may demonstrate, and c) reduce caregiver stress through more effective interactions.

To make this training widely accessible to parents of children with autism, we will deliver this training through a web-based, multi-media, interactive tutorial. The tutorial will use principles of instructional design to more effectively deliver the material and utilize high levels of interactivity afforded by the web-based platform to maximize learning. The tutorial teaches skills to improve their child's behavior and communication within the framework of everyday routines and activities, utilizing interactive exercises and a comprehensive set of videos of real parents implementing these strategies with their children within the context of everyday situations.

The specific aims of the proposed Phase II study are:

Aim 1. To evaluate parents' satisfaction and acceptance of the tutorial program Aim 2. To demonstrate the tutorial increases parental knowledge of the principles and techniques for improving effective parenting of children with Autism Spectrum Disorder.

Aim 3. To demonstrate behavioral improvements in actual parenting skills during the daily interactions with their child based on the knowledge gained.

Aim 4. To demonstrate that the improved parenting skills result in social, communication, and behavioral improvements in the children of parents who complete the tutorial.

Aim 5. To demonstrate that improving parenting skills through the use of this web-based tutorial program reduces caregiver stress and depression.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date September 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Months to 6 Years
Eligibility Inclusion Criteria:

- parents or caregivers of children with ASD between the ages of 18 months and 6 years with an autism spectrum disorder

Exclusion Criteria:

- Ability to read and understand English

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
On LIne Parent Training Tutorial
Interactive on line tutorial for parenting skills for autism

Locations

Country Name City State
United States Center for Psychological Consulation Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
Center for Psychological Consultation National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kobak KA, Stone WL, Wallace E, Warren Z, Swanson A, Robson K. A web-based tutorial for parents of young children with autism: results from a pilot study. Telemed J E Health. 2011 Dec;17(10):804-8. doi: 10.1089/tmj.2011.0060. Epub 2011 Oct 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other The Parent Interview for Autism-Clinical Version 8 weeks No
Other Parenting Efficacy Scale 8 weeks No
Other Parenting Stress Index 8 weeks No
Other Child and Parent Behavior Form 8 weeks No
Primary System Usability Scale User satisfaction with the technical aspects of the Enhancing Interactions tutorial will be assessed using the ratings on the System Usability Scale (SUS). The SUS is a reliable, well-validated 10-item scale 1,49 designed to evaluate the usability and user satisfaction with web-based applications and other technologies. It yields quantitative feedback on a 0-100 scale regarding the effectiveness, efficiency, and satisfaction of users while interacting with engineered systems. 8 weeks No
Secondary Autism Knowledge Test Gains in parents' knowledge regarding of the principles and techniques for more effective parenting of children will be demonstrated using a pre and post test of 24-items developed by the content experts (Drs. Stone and Warren, and Lisa Wallace) that covers the core concepts of the tutorials. The test items were piloted in parents who (a) had received face-to-face training during Enhancing Interactions seminars and (b) other parents prior to being trained. Items were selected based on their psychometric properties and sensitivity to discriminate between parents who had and had not been exposed to the Enhancing Interactions training. 8 weeks No
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