Feeding DisorderNCT03820869
The Effect Of Occupational Therapy On Sensory-Based Feeding Problems
A study testing Family Training and Occupational Therapy in people with Feeding Disorder and Autism Spectrum Disorder, run by Hacettepe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Feeding Disorder, Autism Spectrum Disorder, Sensory Integration Disorder (Disorder)
- What is being tested?
- Family Training and Occupational Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASD
- Feeding problems
Who cannot join
None listed.
About this study
Official title: The Effect Of Occupational Therapy On Sensory-Based Feeding Problems Of Children Wth Autism Spectrum Disorder
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.
Read the detailed description
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.
- Being tested
- Family Training, Occupational Therapy
- Medical subject headings
- Feeding and Eating Disorders, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family TrainingOther
Family Training
Occupational TherapyOther
Occupational Therapy
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Children with ASD Receives: Other: Family Training |
| Intervention | Experimental | Children with ASD Receives: Other: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (2)
BAMBİ
The BAMBI is rated based on a parent proxy report, with a 5-point grading type scale (1 = Never/Very Rarely -5 = At Almost All Mealtimes). It was designed to capture mealtime behaviors specific to children with ASD.
Measured: 8 weeks
STEP
It is used for to identify the feeding problems of persons with ID in terms of (a) risk of aspiration, (b) food selectivity, (c) feeding skills deficits, (d) food refusal and associated behavior problems, and (e) nutrition-related behavior problems
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study startMar 2019 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding DisorderStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgü İNAL, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820869
- Sponsor's protocol ID
- 2018/454
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2019
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Occupational Therapy On Sensory-Based Feeding Problems Of Children Wth Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03820869
- Acronym / sponsor ID
- 2018/454
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Family TrainingChildren with ASD |
| Intervention | Experimental | Other: Occupational TherapyChildren with ASD |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASD
- Feeding problems
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family TrainingFamily Training | Other | Control |
| Occupational TherapyOccupational Therapy | Other | Intervention |
Primary outcome
Dunn Sensory Profile
Time frame: 8 weeks
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
2 secondary outcomes
BAMBİ
Time frame: 8 weeks
STEP
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Family Training and Occupational Therapy in people with Feeding Disorder and Autism Spectrum Disorder, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dunn Sensory Profile (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.