- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03055533
Headsprout Reading Program in Children With Autism Spectrum Disorder and Reading Delay
A Feasibility Study of Headsprout Reading Program in Children With Autism Spectrum Disorder and Reading Delay
Headsprout is a commercially available computer-based reading program that teaches children fundamental reading skills, including phonics, fluency, and comprehension. The Headsprout reading intervention has been shown to be effective with children with various levels of reading skills, but it has not been rigorously tested in children with autism spectrum disorder (ASD). The purpose of this study is to evaluate the effectiveness of Headsprout in a pilot sample of 18 children with ASD and reading delays to serve as a foundation for a larger, future randomized clinical trial (RCT).
Eighteen participants will be included in the study and randomly assigned to one of two groups; the first group will immediately receive treatment with the Headsprout reading program and the second treatment group will receive treatment after 12 weeks. Treatment sessions will occur for one to two hours, two to four days a week, for twelve weeks. The participants who do not receive treatment immediately will be asked to complete reading assessments periodically throughout their wait time. Participation may occur in clinic or via telehealth.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A large number of children with autism spectrum disorder (ASD) experience reading delays, yet few empirically supported reading interventions exist for this population. Reading delay can interfere with academic progress, impede vocational opportunities, hinder self-expression, and limit capacity for independent living. Accessing empirically supported interventions for reading skills can be difficult, with parents of children with ASD facing long waiting lists at specialty clinics, reflecting the simple fact that demand is greater than the supply of trained providers. There is a pressing need for access to affordable interventions that do not depend on specialty clinics.
As a commercially available, computer-based program, Headsprout may be a good fit for children with ASD. Headsprout has shown effectiveness in children with reading delay uncomplicated by ASD, but has not been rigorously studied in children with ASD. This study will investigate the effects of the Headsprout reading program on improving reading skills of children with autism. Eighteen children will be recruited and the researchers will evaluate their current language use by: 1) asking their parents to rate their child's language, 2) completing an echoic skill assessment. Current reading skills will be determined by administering a reading assessment that evaluates their reading accuracy and fluency.
Participants will be randomly assigned to one of two groups; the first group will immediately receive treatment with the Headsprout reading program and the second treatment group will receive treatment after 12 weeks. Participation may be in clinic or via telehealth. During the intervention, children will meet with a trained therapist, several times per week for approximately twelve weeks. The therapist will instruct them to complete various reading activities on the computer. These reading activities may include tasks such as receptively identifying letter names and letter sounds presented on the computer or practicing saying sounds out loud and blending combinations of sounds together.
The participants who do not receive treatment immediately will be asked to complete reading assessments periodically throughout their wait time. At the end of 12 weeks these participants will be able to start the Headsprout reading program.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 7.0 to 18.9
- Confirmed clinical diagnosis of autism spectrum disorder (ASD)
- Minimum score of 40 on the Early Echoic Skills Assessment (EESA), which assesses language skills
- Minimum score of 20 on the Expressive Vocabulary Test (EVT), which assesses language skills
- Display deficits in reading, testing at least one grade levels below current grade level on the Dynamic Indicators of Basic Early Literacy Skills (DIBELS)
- English is primary language
Exclusion Criteria:
- Currently receiving an individualized intervention for reading
- Significant problem behavior
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate intervention with Headsprout reading program
Participants randomized to this study arm will begin treatment with the Headsprout program right away.
Reading assessments will occur at the beginning and end of 12 weeks of treatment.
Participation may be in clinic or via telehealth.
|
Headsprout is a commercially available, computer-based program reading intervention that can be tailored to meet the individual needs of each child.
Participants will have treatment sessions with a trained therapist lasting one to two hours, two to four days a week, for approximately twelve weeks.
|
|
No Intervention: Delayed intervention
Participants randomized to this study arm will have reading assessments at the beginning and end of the study, but they will not begin treatment with the Headsprout program until after their participation in the study ends (12 weeks).
Participation may be in clinic or via telehealth.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Kaufman Test of Educational Achievement score (KTEA-3)
Time Frame: Baseline and Week 12
|
The Kaufman Test of Educational Achievement (KTEA™-3) measures academic achievement and identifies learning disabilities for children in pre-kindergarten through grade 12.
The KTEA™-3 evaluates reading, math, written language and oral language.
For this study we will only use the reading portion of this assessment.
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Baseline and Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Dynamic Indicators of Basic Early Literacy Skills (DIBELS) assessment score
Time Frame: Baseline and Week 12
|
The Dynamic Indicators of Basic Early Literacy Skills (DIBELS) assessment will be used to measure acquisition of early literacy skills, such as letter sounds, and oral reading fluency.
The assessment provides a score for the number of letters read correctly per minute, the number of letter sounds read correctly per minute, the number of nonsense words read correctly per minute, and the number of words read correctly per minute.
DIBELS is designed for children in kindergarten through 6th grade.
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Baseline and Week 12
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bethany A Hansen, PhD, BCBA-D, University of Nebraska
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0275-18-EP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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