Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03055533 |
| Other study ID # |
0275-18-EP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2018 |
| Est. completion date |
June 24, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
University of Nebraska |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
