NCT03138551|CompletedDMC
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Sponsor study identifier
interventional
20
1 country
1
Study Start
October 11, 2015
Actual (reported)Primary Completion
October 1, 2018
Actual (reported)Study Completion
October 1, 2018
Actual (reported)This study will examine the feasibility and preliminary effects of the Mealtime PREP (Promoting Routines of Exploration and Play) intervention package for young children with Sensory Food Aversions and their parents.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2015
Actual (reported)April 28, 2017
Actual (reported)May 3, 2017
Actual (reported)October 1, 2018
Actual (reported)October 1, 2018
Actual (reported)Food Acceptance
Significant change in percentage of targeted food accepted between phases.
30 meals video recorded throughout study participation (10 per phase, 1 month)
3-Day Food Diary
Baseline through Study Completion (1 month)
Behavioral Pediatric Feeding Assessment (BPFAS)
Baseline through Study Completion (1 month)
Every participant enrolled in this single-case experimental design trial with multiple replications progressed through three phases. A: Baseline - typical mealtimes in the home. B: Parent-Training - parents trained in Mealtime PREP (Promoting Routines of Exploration and Play) intervention. B-prime: Family Autonomy - parents continue to deliver treatment strategies. Therapist support withdrawn.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
Caldwell AR, Skidmore ER, Raina KD, Rogers JC, Terhorst L, Danford CA, Bendixen RM. Behavioral Activation Approach to Parent Training: Feasibility of Promoting Routines of Exploration and Play During Mealtime (Mealtime PREP). Am J Occup Ther. 2018 Nov/Dec;72(6):7206205030p1-7206205030p8. doi: 10.5014/ajot.2018.028365.
Angela R Caldwell, PhD
University of Pittsburgh
20 participants (actual enrollment reported by the registry).
First Submitted
April 28, 2017
First Posted
May 3, 2017
Study Start
October 11, 2015
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 1, 2018
Actual (reported)Study Completion
October 1, 2018
Actual (reported)Last Updated
February 6, 2019
Record last verified: 2019-02
There is currently no plan to make individual participant data available to other researchers.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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