NCT03195244

Brief Summary

To compare the efficacy of one-on-one versus group-based aquatic therapy on the social interactions, behaviors and physical activities of children with autism spectrum disorders (ASDs).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

4.8 years

First QC Date

June 12, 2017

Last Update Submit

April 20, 2022

Conditions

Autism Spectrum Disorder

Keywords

aquatic therapy, hydrotherapy

Outcome Measures

Primary Outcomes (1)

  • Change in PedsQL Score

    Survey

    Baseline and 10 weeks after intervention

Study Arms (3)

Observation

NO INTERVENTION

One-on-one Aquatic Therapy

ACTIVE COMPARATOR
Other: Aquatic Physical Therapy

Group Aquatic Therapy

EXPERIMENTAL
Other: Aquatic Physical Therapy

Interventions

Aquatic Physical TherapyOTHER

Swim Whisperer's Aquatic Therapy Sessions

Group Aquatic TherapyOne-on-one Aquatic Therapy

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • Not willing to undergo an investigational treatment
  • Unable to cooperate well enough to safely participate in aquatic therapy under the protocol guidelines
  • Known allergies to pool chemicals
  • Other significant co-morbidities which may include (but is not limited to): severe cerebral palsy with low motor function, advanced pulmonary disease, home oxygen requirement, spina bifida with low motor function, permanent feeding tubes, poorly controlled seizure disorder, chronic indwelling urinary catheters or any condition causing severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turn Center

Amarillo, Texas, 79106, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 22, 2017

Study Start

June 12, 2017

Primary Completion

April 12, 2022

Study Completion

April 12, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)