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Headsprout Reading Program in Children With Autism Spectrum Disorder and Reading Delay

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Headsprout reading program
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring Behavioral, Social, Headsprout reading program

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate intervention with Headsprout reading program

Delayed intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 14, 2017
Last Updated
September 27, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT03055533
Brief Title
Headsprout Reading Program in Children With Autism Spectrum Disorder and Reading Delay
Official Title
A Feasibility Study of Headsprout Reading Program in Children With Autism Spectrum Disorder and Reading Delay
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 3, 2022 (Actual)
Study Completion Date
June 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Behavioral, Social, Headsprout reading program

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate intervention with Headsprout reading program
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Headsprout reading program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Kaufman Test of Educational Achievement score (KTEA-3)
Description
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.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change in the Dynamic Indicators of Basic Early Literacy Skills (DIBELS) assessment score
Description
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.
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bethany A Hansen, PhD, BCBA-D
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Headsprout Reading Program in Children With Autism Spectrum Disorder and Reading Delay

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