Autistic DisorderNCT02184390
Parenting Your Young Child With Autism: A Web-Based Tutorial
A study testing On LIne Parent Training Tutorial in people with Autistic Disorder, run by Center for Psychological Consultation at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 months to 6 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- On LIne Parent Training Tutorial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- parents or caregivers of children with ASD between the ages of 18 months and 6 years with an autism spectrum disorder
Who cannot join
- Ability to read and understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Psychological Consulation
Madison, Wisconsin, 53717
About this study
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.
Read the 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.
- Conditions
- Autistic Disorder
- Being tested
- On LIne Parent Training Tutorial
- Keywords
- Internet, Education
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On LIne Parent Training TutorialOther
Interactive on line tutorial for parenting skills for autism
| Study group | Role | What they receive |
|---|---|---|
| tutorial | Experimental | Parents who receive access to the tutorial immediately Receives: Other: On LIne Parent Training Tutorial |
| wait list control | No intervention | Parents who are assessed at the same time points as the intervention arm, but do no receive access to the tutorial |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Psychological Consultation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kenneth A. Kobak, Ph.D., Center for Psychological Consultation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184390
- Sponsor's protocol ID
- 5R44MH086936
- Other IDs
- 5R44MH086936
- Status last verified
- Feb 2016
- First submitted
- 3 Jul 2014
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22011005
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenting Your Young Child With Autism: A Web-Based Tutorial
- ClinicalTrials.gov ID
- NCT02184390
- Acronym / sponsor ID
- 5R44MH086936
- Conditions
- Autistic Disorder
- Keywords
- Internet, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Center for Psychological ConsultationUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tutorial | Experimental | Other: On LIne Parent Training TutorialParents who receive access to the tutorial immediately |
| wait list control | No intervention | –Parents who are assessed at the same time points as the intervention arm, but do no receive access to the tutorial |
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- parents or caregivers of children with ASD between the ages of 18 months and 6 years with an autism spectrum disorder
Key exclusion criteria (1 listed)
- Ability to read and understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On LIne Parent Training TutorialInteractive on line tutorial for parenting skills for autism | Other | tutorial |
Primary outcome
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.
1 secondary outcome
Autism Knowledge Test
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Background: PubMed 22011005Kobak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On LIne Parent Training Tutorial in people with Autistic Disorder, run by Center for Psychological Consultation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02184390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.