NCT04075552

Brief Summary

Most studies which have addressed food selectivity among children with autism spectrum disorders have been conducted in either clinic or home settings. School-based research has been conducted to increase healthy eating, but this research was largely conducted with children without special needs or if children with special needs did participate, they were not identified. This study will focus on increasing consumption of fruits and vegetables among children with an Autism Spectrum Disorder in a school setting.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

6 years

First QC Date

August 28, 2019

Last Update Submit

September 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Increased consumption of healthy foods

    Direct measure of the number of healthy foods items eaten

    Through study completion, 1 year.

Study Arms (1)

Participants

EXPERIMENTAL

Participants are students from a specialized school for children with autism.

Behavioral: Pre Meal PresentationBehavioral: Pre Meal Presentation + ModelingBehavioral: Pre Meal Presentation + Token Economy

Interventions

Pre-Meal Presentation. In the Pre-Meal Presentation (PMP) condition, school staff delivered the plate of vegetable pieces prior to students regularly scheduled lunchtime (about 5 min). Like baseline, no programmed consequences were provided for student interaction or consumption of the vegetables.

Participants

Similar to the prior condition, each participant will be offered a plate containing target foods for 4 min. Once the plate has been delivered to each participant, a staff person will model eating the food. The model will have an identical plate of food. Within six feet of students oriented towards the model (i.e., the students will be facing the model), the model will pick up one piece of food, say "Yum, this looks good" in a loud and excited tone, eat it, and then deliver a "soft" prompt to the participants to try it (e.g., "You should try this!"). Staff will avoid giving a firm/hard demand (e.g., "Eat the food"). Repeat this for four pieces of food, alternating between the two target foods, with about 10-20 sec between each bite. Repeat the model as necessary based on the room arrangement, such that each students contacts the model within six feet while oriented towards the model.

Participants

Similar to prior condition, expect each participant can earn tokens for eating food items. Tokens can be exchanged for small prizes (e.g., pencil or sticker) at the end of a session.

Participants

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants will be students in a private school with a diagnosis of an autism spectrum disorder and between 6-14 years of age.

You may not qualify if:

  • Parents who report their children have food allergies of any kind will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hogan Learning Academy

Fleetwood, Pennsylvania, 19522, United States

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single subject research methodology
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

August 28, 2019

First Posted

August 30, 2019

Study Start

September 23, 2016

Primary Completion

September 26, 2022

Study Completion

September 26, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Locations