Autism Clinical Trial
Official title:
Handheld Technology for Speech Development in Students With Autism Spectrum Disorders
Verified date | June 2016 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The purpose of this study is to evaluate the utility of a specialized iPad application designed to treat difficulties with intonation (e.g., melody in voice) in children with autism spectrum disorders (ASD) and other communication disorders.
Status | Completed |
Enrollment | 200 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 18 Years |
Eligibility |
Inclusion Criteria: - SLPs, in Connecticut Public Schools, who provide intervention to students with autism spectrum disorders and related disorders - Students, ages 4-18, who attend school in Connecticut and demonstrate prosodic difficulties secondary to a diagnosis of ASD, apraxia of speech, or other communication disorder Exclusion Criteria: - Students with concomitant genetic disorders |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Yale Child Study Center | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | Handhold Adaptive, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of software | The effectiveness of the software will be measured in two ways. Perceptual ratings of prosody. Pre- and post-treatment speech samples will be collected from each student participant. These samples will be rated by a member of the research staff on the following prosodic characteristics: rate, rhythm, stress, volume. Questionnaires. Questionnaires will be completed pre- and post-treatment by the students' classroom teacher and speech-language pathologist. These questionnaires will measure the students' use and generalization of skills taught during the intervention. |
12 months | No |
Secondary | Usability of software | Usability of software will be measured through questionnaires completed by the speech-language pathologists. Questionnaires will measure ease of software use, utility of software functions, and student engagement during intervention sessions. | 12 months | No |
Secondary | Student engagement in treatment | Student engagement will be evaluated indirectly by rating scales completed by the speech-language pathologist. Likert scales will be used to quantify student engagement on the following parameters: time engaged in on-task behavior, time engaged in off-task behavior, perceived enjoyment of software. | 12 months | No |
Secondary | Improvement in peer acceptance | Changes in peer acceptance will be evaluated using two different methodologies. Classroom teacher questionnaire. Each student's classroom teacher will complete a questionnaire pre- and post-treatment measuring the student's interaction with classroom peers. Semi-structured observation. A member of the research staff will observe each student pre- and post-treatment and complete frequency tallies on the number of peer interactions initiated during a 15-minute semi-structured activity. |
12 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05302167 -
Molehill Mountain Feasibility Study.
|
N/A | |
Completed |
NCT04167839 -
Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement
|
N/A | |
Terminated |
NCT04049981 -
Investigation of Mechanisms of Action in Superpower Glass
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT06080087 -
Implementation Toolkit to Enhance EBP Among Marginalized Families
|
N/A | |
Recruiting |
NCT04107064 -
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
|
N/A | |
Completed |
NCT03206996 -
Exposure Therapy for Auditory Sensitivity in Autism
|
N/A | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Completed |
NCT05588570 -
Coaching Children With Anxiety and Autism Through Telehealth
|
N/A | |
Enrolling by invitation |
NCT06058104 -
Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism
|
N/A | |
Completed |
NCT02847182 -
Cord Blood Infusion for Children With Autism Spectrum Disorder
|
Phase 2 | |
Completed |
NCT03002363 -
The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance
|
Phase 1 | |
Withdrawn |
NCT02414451 -
Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response
|
N/A | |
Completed |
NCT02911194 -
a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)
|
N/A | |
Completed |
NCT02508922 -
Trial of Vitamin D3 Supplementation in Paediatric Autism
|
N/A | |
Completed |
NCT02708290 -
Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
|
||
Completed |
NCT02536365 -
Sensory Integration Therapy in Autism: Mechanisms and Effectiveness
|
N/A | |
Completed |
NCT02720900 -
Prebiotic Intervention for Autism Spectrum Disorders
|
N/A | |
Recruiting |
NCT02255565 -
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
|
Phase 4 | |
Recruiting |
NCT01836562 -
A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism
|
Phase 1/Phase 2 | |
Completed |
NCT02154828 -
Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)
|