Treatment of Feeding Problems in Children With ASDPT-FNCT02275715
Treatment of Feeding Problems in Children With Autism
A study testing Parent Training Program in people with Treatment of Feeding Problems in Children With ASD, run by University of Florida at 2 sites in United States.
Trial summary
The primary aim of the project is to develop and pilot a manualized, individually delivered Parent Training Program for Feeding Problems (PT-F) in children with autism spectrum disorder (ASD) to assess feasibility and parent acceptance of the program. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Treatment of Feeding Problems in Children With ASD
- What is being tested?
- Parent Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to 25 Jun 2017
- 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females >=2 and < 8 years of age.
- At least one participating parent resides with the child >50% of time.
- Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of Autism Spectrum Disorder as established by clinical assessment, corroborated by the Autism Diagnostic Interview - Revised (ADI-R) and Autism Diagnostic Observation Schedule - 2nd Edition (ADOS2).
- A total score of > 54 on the Brief Autism Mealtime Behavior Inventory. A score of 54 is one standard deviation above the mean for the ASD group, as reported by the developers.
- A receptive language level of 12 months or greater. [Rationale: diagnostic uncertainty of ASD in children functioning below 12 months of age and the need for the child to understand simple instructions in PT-F].
- Medication free or stable medications and/or supplements (no changes in past 6 weeks and no planned changes during study period). [Rationale: Many children with ASD are on medications to target associated behaviors. These include stimulants and atypical antipsychotics. Excluding these children could result in a non-representative sample of children with ASD and feeding problems. We will require that the feeding problems pre-date the initiation of medications / supplements].
Who cannot join
- Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of Rett's Disorder or Childhood Disintegrative Disorder.
- Presence of a known serious medical condition in the child influencing the management of diet and treatment impacting diet or appetite (e.g., current or past gastroesophageal reflux disease, significant food allergies, diabetes, cystic fibrosis, celiac disease, endocrine disorder, genetic disorders known to impact growth or appetite). [Rationale: these children may require different treatments than the behaviorally based parent training intervention].
- Significant oral motor dysfunction (i.e., unable to safely chew and swallow age appropriate textures).
- Presence of known psychiatric diagnosis in the child that would require a different treatment (e.g., psychotic disorder, major depression).
- Inpatient hospitalization.
- Being fed via nasogastric or gastrostomy tube in the past year.
- On medication or supplements specifically targeting appetite.
- Insufficient proficiency of English language prohibiting comprehension of PT-F. [Rationale: Parents will need sufficient command of English to benefit from the English materials].
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32611
University of Rochester
Rochester, New York, 14627
About this study
The primary aim of the project is to develop and pilot a manualized, individually delivered Parent Training Program for Feeding Problems (PT-F) in children with autism spectrum disorder (ASD) to assess feasibility and parent acceptance of the program. The secondary aim of the project is to assess the success of the PT-F program in improving mealtime behavior problems when compared to the wait-list control.
Exploratory aims include obtaining preliminary data on the impact of PT-F on child and parent functioning (reducing parent stress and improving parent sense of competency and parent-child interactions at mealtime), assessing the impact of treatment on interfering behaviors around mealtime/snack times, and measuring nutritional improvements after treatment.
Read the detailed description
Fifty well characterized children will be randomly assigned to either the 20 week PT-F or a waitlist control group. Study assessments evaluating feeding and mealtime behaviors, nutritional intake, daytime behaviors, repetitive behaviors, sensory sensitivities, parent stress and parent-child interactions will be completed at Baseline, Week 10, and Week 20 timepoints. Treatment Fidelity forms will be completed by the therapist at the end of each treatment session to assess achievement of session goals and parent adherence during each session.
- Being tested
- Parent Training Program
- Keywords
- autism spectrum disorder (ASD), feeding problems
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Training ProgramBehavioural
Also called PT-F
An 11-session manualized behavioral parent training program for the treatment of feeding problems teaching parents to use a range of behavioral procedures to address a variety of common feeding problems.
| Study group | Role | What they receive |
|---|---|---|
| Parent Training Program (PT-F) | Experimental | Treatment group Receives: Behavioral: Parent Training Program |
| Waitlist | No intervention | Control group in which parents randomized to this group will be offered the PT-F at the end of the 20 week study period to address their child's feeding issues. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with Complete Data
Measure of feasibility of randomized controlled trial by successful recruitment of 50 subjects with complete data collected from > 80% (> 40) subjects.
Measured: Week 20
Treatment Fidelity
Measure of therapists' ability to deliver PT-F with > 80% average fidelity as rated by fidelity checklists
Measured: Week 20
Parent Adherence
Measure of parent adherence to the intervention as evidenced by average attendance of > 80% of scheduled sessions and successful completion of > 70% of session activities as rated from adherence checklists.
Measured: Week 20
Secondary outcomes (1)
Brief Autism Mealtime Behavior Inventory (BAMBI)
Measure of mealtime behavior problems
Measured: Baseline, Week 10, Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completion25 Jan 2017
- Study completion25 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Feeding Problems in Children With ASDStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia R Johnson, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275715
- Sponsor's protocol ID
- IRB201400831-N
- Acronym
- PT-F
- Status last verified
- Apr 2018
- First submitted
- 15 Oct 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Feeding Problems in Children With Autism
- ClinicalTrials.gov ID
- NCT02275715
- Acronym / sponsor ID
- PT-F / IRB201400831-N
- Keywords
- autism spectrum disorder (ASD), feeding problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of Rochester, National Institute of Mental Health (NIMH)
- Study start
- Feb 2015
- Primary completion
- 25 Jan 2017 (actual)
- Study completion
- 25 Jun 2017 (actual)
- First posted
- 27 Oct 2014 (estimated)
- 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.
The primary aim of the project is to develop and pilot a manualized, individually delivered Parent Training Program for Feeding Problems (PT-F) in children with autism spectrum disorder (ASD) to assess feasibility and parent acceptance of the program. The secondary aim of the project is to assess the success of the PT-F program in improving mealtime behavior problems when compared to the wait-list control.
Exploratory aims include obtaining preliminary data on the impact of PT-F on child and parent functioning (reducing parent stress and improving parent sense of competency and parent-child interactions at mealtime), assessing the impact of treatment on interfering behaviors around mealtime/snack times, and measuring nutritional improvements after treatment.
Detailed description
Fifty well characterized children will be randomly assigned to either the 20 week PT-F or a waitlist control group. Study assessments evaluating feeding and mealtime behaviors, nutritional intake, daytime behaviors, repetitive behaviors, sensory sensitivities, parent stress and parent-child interactions will be completed at Baseline, Week 10, and Week 20 timepoints. Treatment Fidelity forms will be completed by the therapist at the end of each treatment session to assess achievement of session goals and parent adherence during each session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Training Program (PT-F) | Experimental | Behavioral: Parent Training ProgramTreatment group |
| Waitlist | No intervention | –Control group in which parents randomized to this group will be offered the PT-F at the end of the 20 week study period to address their child's feeding issues. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Males and females >=2 and < 8 years of age.
- At least one participating parent resides with the child >50% of time.
- Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of Autism Spectrum Disorder as established by clinical assessment, corroborated by the Autism Diagnostic Interview - Revised (ADI-R) and Autism Diagnostic Observation Schedule - 2nd Edition (ADOS2).
- A total score of > 54 on the Brief Autism Mealtime Behavior Inventory. A score of 54 is one standard deviation above the mean for the ASD group, as reported by the developers.
- A receptive language level of 12 months or greater. [Rationale: diagnostic uncertainty of ASD in children functioning below 12 months of age and the need for the child to understand simple instructions in PT-F].
Key exclusion criteria (8 listed)
- Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of Rett's Disorder or Childhood Disintegrative Disorder.
- Presence of a known serious medical condition in the child influencing the management of diet and treatment impacting diet or appetite (e.g., current or past gastroesophageal reflux disease, significant food allergies, diabetes, cystic fibrosis, celiac disease, endocrine disorder, genetic disorders known to impact growth or appetite). [Rationale: these children may require different treatments than the behaviorally based parent training intervention].
- Significant oral motor dysfunction (i.e., unable to safely chew and swallow age appropriate textures).
- Presence of known psychiatric diagnosis in the child that would require a different treatment (e.g., psychotic disorder, major depression).
- Inpatient hospitalization.
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 |
|---|---|---|
| Parent Training ProgramAlso: PT-FAn 11-session manualized behavioral parent training program for the treatment of feeding problems teaching parents to use a range of behavioral procedures to address a variety of common feeding problems. | Behavioural | Parent Training Program (PT-F) |
Primary outcome
Number of Subjects with Complete Data
Time frame: Week 20
Measure of feasibility of randomized controlled trial by successful recruitment of 50 subjects with complete data collected from > 80% (> 40) subjects.
Treatment Fidelity
Time frame: Week 20
Measure of therapists' ability to deliver PT-F with > 80% average fidelity as rated by fidelity checklists
Parent Adherence
Time frame: Week 20
Measure of parent adherence to the intervention as evidenced by average attendance of > 80% of scheduled sessions and successful completion of > 70% of session activities as rated from adherence checklists.
1 secondary outcome
Brief Autism Mealtime Behavior Inventory (BAMBI)
Time frame: Baseline, Week 10, Week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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.
Cynthia R Johnson, PhD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Training Program in people with Treatment of Feeding Problems in Children With ASD, run by University of Florida at 2 sites in United States.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Subjects with Complete Data (time frame: Week 20). The study lists 3 primary outcomes in all. 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 5 Apr 2018.