Autism Spectrum DisorderNCT03055533
Headsprout Reading Program in Children With Autism Spectrum Disorder and Reading Delay
A study testing Headsprout reading program in people with Autism Spectrum Disorder, run by University of Nebraska at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Headsprout reading program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 24 Jun 2022
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Currently receiving an individualized intervention for reading
- Significant problem behavior
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Headsprout reading program
- Keywords
- Behavioral, Social, Headsprout reading program
- Medical subject headings
- Autism Spectrum Disorder, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headsprout reading programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention with Headsprout reading program | Experimental | 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. Receives: Behavioral: Headsprout reading program |
| Delayed intervention | No 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Kaufman Test of Educational Achievement score (KTEA-3)
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.
Measured: Baseline and Week 12
Secondary outcomes (1)
Change in the Dynamic Indicators of Basic Early Literacy Skills (DIBELS) assessment score
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start1 Oct 2018
- Primary completion3 Mar 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bethany A Hansen, PhD, BCBA-D, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055533
- Sponsor's protocol ID
- 0275-18-EP
- Status last verified
- Sep 2023
- First submitted
- 14 Feb 2017
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Headsprout Reading Program in Children With Autism Spectrum Disorder and Reading Delay
- ClinicalTrials.gov ID
- NCT03055533
- Acronym / sponsor ID
- 0275-18-EP
- Conditions
- Autism Spectrum Disorder
- Keywords
- Behavioral, Social, Headsprout reading program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 16 Feb 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention with Headsprout reading program | Experimental | Behavioral: Headsprout reading programParticipants 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. |
| Delayed intervention | No 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Currently receiving an individualized intervention for reading
- Significant problem behavior
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 |
|---|---|---|
| Headsprout reading programHeadsprout 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. | Behavioural | Immediate intervention with Headsprout reading program |
Primary outcome
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.
1 secondary outcome
Change in the Dynamic Indicators of Basic Early Literacy Skills (DIBELS) assessment score
Time frame: Baseline and Week 12
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 29 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Bethany A Hansen, PhD, BCBA-D principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Headsprout reading program in people with Autism Spectrum Disorder, run by University of Nebraska 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 6 inclusion and 2 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 29 Sep 2023. 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?
Change in Kaufman Test of Educational Achievement score (KTEA-3) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2023.