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

NCT03055533 | Completed

• 1 other identifier: 0275-18-EP
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Behavioral; Social; Headsprout reading program

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 12

Secondary Outcomes (1)

• Change in the Dynamic Indicators of Basic Early Literacy Skills (DIBELS) assessment score

  Baseline and Week 12

Study Arms (2)

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.

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.

Interventions

Headsprout reading program BEHAVIORAL

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.

Immediate intervention with Headsprout reading program

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Currently receiving an individualized intervention for reading
• Significant problem behavior

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Bethany A Hansen, PhD, BCBA-D

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: October 1, 2018
• Primary Completion: March 3, 2022
• Study Completion: June 24, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)