NCT03820869

Brief Summary

Feeding problems are common in individuals with Autism Spectrum Disorder (ASD).This study was planned to investigate the effect of occupational theraphy on sensory feeding problems in ASD.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Status
unknown

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

January 18, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

January 18, 2019

Last Update Submit

January 27, 2019

Conditions

Feeding DisorderAutism Spectrum DisorderSensory Integration Disorder (Disorder)

Outcome Measures

Primary Outcomes (1)

  • Dunn Sensory Profile

    It is a norm-referenced, parent-report questionnaire. The parent rates frequency of each item on a 5-point Likert scale from 1= always to 5= never. It reports the frequency of behavioural occurrences that are used to measure the patterns of performance indicative of difficulties experienced in sensory processing

    8 weeks

Secondary Outcomes (2)

  • BAMBİ

    8 weeks

  • STEP

    8 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Children with ASD

Other: Family Training

Intervention

EXPERIMENTAL

Children with ASD

Other: Occupational Therapy

Interventions

Family TrainingOTHER

Family Training

Control
Occupational TherapyOTHER

Occupational Therapy

Intervention

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASD
  • Feeding problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding and Eating DisordersAutism Spectrum Disorder

Interventions

Sex EducationOccupational Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersChild Development Disorders, PervasiveNeurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

SexologyBehavioral SciencesBehavioral Disciplines and ActivitiesRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

January 18, 2019

First Posted

January 29, 2019

Study Start

March 1, 2019

Primary Completion

May 1, 2019

Study Completion

July 1, 2019

Last Updated

January 29, 2019

Record last verified: 2019-01