- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02184390
Parenting Your Young Child With Autism: A Web-Based Tutorial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53717
- Center for Psychological Consulation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tutorial
Parents who receive access to the tutorial immediately
|
Interactive on line tutorial for parenting skills for autism
|
No Intervention: wait list control
Parents who are assessed at the same time points as the intervention arm, but do no receive access to the tutorial
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
System Usability Scale
Time Frame: 8 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autism Knowledge Test
Time Frame: 8 weeks
|
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
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Parent Interview for Autism-Clinical Version
Time Frame: 8 weeks
|
8 weeks
|
Parenting Efficacy Scale
Time Frame: 8 weeks
|
8 weeks
|
Parenting Stress Index
Time Frame: 8 weeks
|
8 weeks
|
Child and Parent Behavior Form
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R44MH086936 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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