NCT03756844

Brief Summary

This single subject study tested the effectiveness of the Just Right Challenge Food Club for decreasing food selectivity and increasing mealtime qualify for children with developmental disabilities.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

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

Study Start

First participant enrolled

October 19, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
Last Updated

November 30, 2018

Status Verified

November 1, 2018

Enrollment Period

1.1 years

First QC Date

November 12, 2018

Last Update Submit

November 28, 2018

Conditions

Keywords

Avoidant Restrictive Food Intake Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in Food Inventory questionnaire

    Parents marked the foods that their child ate over the past week every week for up to 45 weeks

    Every week for up to 45 weeks

Secondary Outcomes (1)

  • Change in About Your Child's Eating questionnaire

    Up to 45 weeks between pre and post test measures.

Study Arms (1)

Just Right Challenge Food Club Protocol

EXPERIMENTAL

There was only one arm in this study. All participants received the Just Right Challenge Food Club Protocol and single subject (time series) data was collected.

Behavioral: Just Right Challenge Food Club

Interventions

Systematic desensitization, positive reinforcement and escape extinction at a level of just right challenge.

Just Right Challenge Food Club Protocol

Eligibility Criteria

Age2 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children who accepted less than 15 foods as part of their regular diet
  • Children who refused whole food groups

You may not qualify if:

  • Children with life threatening food selectivity per parent report and physician referral information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
There was no masking. This was a single subject study. Participants allowed us to use their clinical data for research purposes.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This was a single-subject (time series design).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, OTRL, Associate Professor

Study Record Dates

First Submitted

November 12, 2018

First Posted

November 28, 2018

Study Start

October 19, 2016

Primary Completion

December 12, 2017

Study Completion

December 12, 2017

Last Updated

November 30, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share