Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06216613
Other study ID # FP00000742
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date August 15, 2025

Study information

Verified date February 2024
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the effects of a specialized swimming and water-safety program (Sensory Enhanced Aquatics) and standard swimming lessons for autistic children. The main question[s]it aims to answer are: - Do Sensory Enhanced Aquatics and standard swimming lessons improve swimming and water-safety skills of autistic children? - Which participant characteristics are associated with the highest post-intervention swim skills and water safety across both groups? Participants will: - Complete questionnaires, motor, and swim tests before the intervention. - participate in 16, 30-minute Sensory Enhanced Aquatics lessons. - Complete a swim test after the intervention. - Complete an interview. Researchers will compare with participation in standard swim lessons to see if which bests teaches swimming and water-safety to autistic children.


Description:

The investigators will conduct a single blind, randomized controlled pilot trial to test the differential effects of an eight-week (16 lesson) Sensory Enhanced Aquatics intervention and standard swim lessons on attainment of swimming and water safety skills of autistic children. Investigators will enroll 50 autistic children aged 5-9 years who will be randomized 1:1 by minimization to either the Sensory Enhanced Aquatics intervention or standard swim lessons to minimize imbalanced group allocation by autism severity and baseline swim skill. Aim 1 will compare the effects of Sensory Enhanced Aquatics to standard swimming lessons on swimming and water safety skills of autistic children with a swim test based on Red Cross water competency guidelines. Aim 2 will assess which participant characteristics (e.g., age, motor ability, autism severity) are associated with the highest post-intervention swim skills and water safety across both groups to inform who benefits most from swim instruction. Child sex and co-occurring motor impairment will be considered as potential covariates. Data will be collected before swim lessons and after 8 weeks of Sensory Enhanced Aquatics or standard lessons. The investigators hypothesize children in both groups will demonstrate improvement in swimming and water safety skills with greater improvements in the Sensory Enhanced Aquatics group; autism severity and motor ability will have the greatest associations with swim skill in both groups. Our exploratory aim will employ post-intervention semi-structured interviews to explore child, parent, and instructor perspectives about instructional methods most effective for developing swimming and water-safety among autistic children. The information obtained from this study will improve our understanding of the best strategies for swim instruction for autistic children and support our long-term goal to make Sensory Enhanced Aquatics scalable on the national level to prevent drowning of autistic children.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date August 15, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers No
Gender All
Age group 5 Years to 9 Years
Eligibility Inclusion Criteria: - Age 5-9 yrs. who have received a clinical diagnosis for autism based on Diagnostic and statistical manual of mental disorders: DSM-5 criteria - A Social Responsiveness Scale-2 (SRS-2) T-score of = 60 - Sufficient functional ability to understand directions and communicate preferences (verbally or non-verbally) - Baseline swim test score =22 - No plans to relocate outside the study area during the intervention period. - Physician consent. Exclusion Criteria: - Uncontrolled epilepsy, as seizures increase risk of drowning. - Baseline swim test score =23 - Aggressive behaviors that would put instructor safety at risk.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sensory Enhanced Aquatics
Sensory Enhanced Aquatics (SEA) utilizes the Sensory Profile to individualize lessons based on children's sensory preferences. The program incorporates evidence-based approaches for autistic children, including: 1) visual supports, 2) sensory supports, 3) communication strategies, 4) behavioral strategies, and 5) modeling to maximize skill acquisition. Lessons will be 1:1 with social opportunities at the beginning and end of each lesson. Like standard swim lessons, skills are taught in progression from water orientation (e.g., blowing bubbles, submerging different body parts) to advanced swimming (e.g., swimming 15 or more yards of different swim strokes). All lessons include instruction of water safety skills. Each skill has been task analyzed by therapists so instruction can be graded according to children's ability. A social story is provided to transition children to lessons. SEA curriculum was reviewed by USA Swimming Foundation and is included as a Swim Lesson Network Provider.
Standard Swim Lessons
Standard swim lessons will adhere to USA Swimming Foundation Swim Network Provider requirements ensuring lessons meet or exceed industry best practices. Lessons have up to a 1:5 instructor to child ratio and will focus on stroke development and water-safety with skills advancing from water-orientation to stroke technique and endurance.

Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)

Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Child Swim Test Individual performance test of 5 American Red Cross water competency skills, 5 preparatory swim skills and 2 water-safety skills scored on a 4-point scale with total scored ranging from 0-38. pre and post 8 weeks
See also
  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 NCT02720900 - Prebiotic Intervention for Autism Spectrum Disorders 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
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
Recruiting NCT02255565 - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study Phase 4
Completed NCT02154828 - Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)