Trial Outcomes & Findings for Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder (NCT NCT06110806)
NCT ID: NCT06110806
Last Updated: 2026-06-10
Results Overview
An MBIE-adapted Therapy Suitability and Acceptability Scale will average specific items from patient's view on match of therapy to the problem, responsiveness of intervention to different treatment challenges, degree of unexpected discomfort related to treatment, interest in using therapy experiences beyond the therapy session. This scale includes 10-20 items, depending on the session content, and is measured using a Likert scale from 1-7. Scores are calculated using a sum of all items, with a possible range of scores of 10 to 140. Higher scores indicate greater suitability of the treatment for the child and expectancy of success with the intervention.
TERMINATED
NA
12 participants
up to 6 months
2026-06-10
Participant Flow
Participant milestones
| Measure |
Mindfulness-based Interoceptive Exposure (MBIE)
Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.
MBIE: MBIE administered over 20 sessions, targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning.
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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12
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Reasons for withdrawal
| Measure |
Mindfulness-based Interoceptive Exposure (MBIE)
Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.
MBIE: MBIE administered over 20 sessions, targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning.
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Overall Study
Adverse Event
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1
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Overall Study
NCCIH terminated study
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11
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Baseline Characteristics
Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder
Baseline characteristics by cohort
| Measure |
Mindfulness-based Interoceptive Exposure (MBIE)
n=12 Participants
Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.
MBIE: MBIE administered over 20 sessions, targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning.
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Age, Continuous
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14.9 years
STANDARD_DEVIATION 2.7 • n=9 Participants
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Sex: Female, Male
Female
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7 Participants
n=9 Participants
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Sex: Female, Male
Male
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5 Participants
n=9 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=9 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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11 Participants
n=9 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=9 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=9 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=9 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=9 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=9 Participants
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Race (NIH/OMB)
White
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9 Participants
n=9 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=9 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=9 Participants
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Body Mass Index (BMI)
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19.6 kg/m^2
STANDARD_DEVIATION 3.8 • n=9 Participants
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Calories consumed during single-item meal
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100 kcal
STANDARD_DEVIATION 145.7 • n=9 Participants
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Child and Adolescent Mindfulness Measure (CAMM)
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29.2 units on a scale
STANDARD_DEVIATION 8.7 • n=9 Participants
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Body Awareness Questionnaire (BAQ)
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56.1 units on a scale
STANDARD_DEVIATION 19.3 • n=9 Participants
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Stanford Feeding Questionnaire - avoidant restrictive food intake disorder (ARFID) Scale
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4.1 units on a scale
STANDARD_DEVIATION 0.9 • n=9 Participants
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Stanford Feeding Questionnaire - Parental Feeding Problems Scale
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1.7 units on a scale
STANDARD_DEVIATION 0.5 • n=9 Participants
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Parental self-efficacy scale
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21.8 units on a scale
STANDARD_DEVIATION 3.5 • n=9 Participants
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PRIMARY outcome
Timeframe: up to 6 monthsPopulation: Data not collected because 6 month visit not completed due to early termination of study.
An MBIE-adapted Therapy Suitability and Acceptability Scale will average specific items from patient's view on match of therapy to the problem, responsiveness of intervention to different treatment challenges, degree of unexpected discomfort related to treatment, interest in using therapy experiences beyond the therapy session. This scale includes 10-20 items, depending on the session content, and is measured using a Likert scale from 1-7. Scores are calculated using a sum of all items, with a possible range of scores of 10 to 140. Higher scores indicate greater suitability of the treatment for the child and expectancy of success with the intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Session 20, at week 20Adherence of the MBIE intervention will be measured with ratings of therapy tapes of 20 sessions. Adherence will be calculated using a dichotomous scale (yes/no) of items rating the extent of use of treatment elements and the quality of delivery of the intervention. As the number of treatment elements vary, and some items are reverse coded, the minimum, maximum, and scaling are not utilized. Per item adherence can range from 0 to 100%.
Outcome measures
| Measure |
Mindfulness-based Interoceptive Exposure (MBIE)
n=2 Participants
Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.
MBIE: MBIE administered over 20 sessions, targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning.
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Therapist Adherence to MBIE Therapy
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64 percentage of adherence to items
Standard Deviation 10
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SECONDARY outcome
Timeframe: Session 20, at week 20Retention will be measured using rates of dropout between baseline and session 20 (end of treatment, at approximately 6 months). Number of participants who withdrew prior to termination of study.
Outcome measures
| Measure |
Mindfulness-based Interoceptive Exposure (MBIE)
n=12 Participants
Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.
MBIE: MBIE administered over 20 sessions, targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning.
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|---|---|
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Number of Participants Who Withdrew
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3 Participants
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SECONDARY outcome
Timeframe: baseline and session 5 (at week 5), session 10 (at week 10), session 20 (at week 20)Population: Number of participants who completed the respective sessions
Acceptability of data collection and assessment procedures will be measured using participant ratings of acceptability for total time and frequency on an investigator-derived scale. This measurement includes items assessing the (1) tolerability and (2) ease of completing laboratory, behavior, and self-report tasks using a 15 mm visual analog scale. Questions are scored from 0-15 and then all scores are summed for an acceptability score. Ranges include 0-120 at baseline, 0 to 30 at Session 5, 0-120 at Session 10, and 0-120 at Session 20. Higher scores indicate greater acceptability of study assessments.
Outcome measures
| Measure |
Mindfulness-based Interoceptive Exposure (MBIE)
n=12 Participants
Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.
MBIE: MBIE administered over 20 sessions, targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning.
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Participant Rating of Acceptability Scale
Session 10
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37.0 score on a scale
Standard Deviation 8.3
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Participant Rating of Acceptability Scale
Session 20
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46.2 score on a scale
Standard Deviation 12.1
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Participant Rating of Acceptability Scale
Baseline
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59.8 score on a scale
Standard Deviation 23.4
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Participant Rating of Acceptability Scale
Session 5
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22.6 score on a scale
Standard Deviation 7.1
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SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Data not collected because 6 month visit not completed due to early termination of study.
The number of MBIE sessions required to achieve a clinically meaningful outcome and acceptable tolerability using a Functional Food Hierarchy. This measurement rates a minimum of 11 food items on a scale of 0-10 at 10 levels of the hierarchy (subjective units of distress). Scores range from 0-100 with higher scores indicating lower avoidance/increased consumption.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Data not collected because 6 month visit not completed due to early termination of study.
The number of MBIE sessions required to achieve a clinically meaningful outcome (consuming food rated as70 or higher on the Food Avoidance Scale). The Food Avoidance Scale is investigator-derived and includes 1 item rated on a scale of 0-100 with higher scores indicating consumption of more challenging/avoided foods.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and approximately 10 weeks and 20 weeksPopulation: Number of participants who completed Session 10 and Session 20
Autonomous eating will be measured in total calories consumed during a single-item meal. Total calories consumed will be calculated between baseline and session 10 of treatment, and between baseline and session 20 of treatment.
Outcome measures
| Measure |
Mindfulness-based Interoceptive Exposure (MBIE)
n=10 Participants
Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.
MBIE: MBIE administered over 20 sessions, targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning.
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Change in Total Calories Consumed
baseline and 10 weeks
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57.2 calories consumed
Standard Deviation 69.4
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Change in Total Calories Consumed
baseline and 20 weeks
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152.0 calories consumed
Standard Deviation 172.0
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SECONDARY outcome
Timeframe: Baseline and session 20 (at week 20)Change in BMI percentile at baseline and end of treatment (session 20) to evaluate any changes during treatment.
Outcome measures
| Measure |
Mindfulness-based Interoceptive Exposure (MBIE)
n=2 Participants
Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.
MBIE: MBIE administered over 20 sessions, targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning.
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|---|---|
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Change in Body Mass Index (BMI) Percentile
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25 percentile
Standard Deviation 32.5
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Adverse Events
Mindfulness-based Interoceptive Exposure (MBIE)
Serious adverse events
| Measure |
Mindfulness-based Interoceptive Exposure (MBIE)
n=12 participants at risk
Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.
MBIE: MBIE administered over 20 sessions, targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning.
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Psychiatric disorders
Suicidal intention
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8.3%
1/12 • Number of events 2 • 20 weeks
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Other adverse events
| Measure |
Mindfulness-based Interoceptive Exposure (MBIE)
n=12 participants at risk
Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.
MBIE: MBIE administered over 20 sessions, targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning.
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Metabolism and nutrition disorders
Dehydration
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8.3%
1/12 • Number of events 1 • 20 weeks
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Metabolism and nutrition disorders
Lack of weight gain
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8.3%
1/12 • Number of events 1 • 20 weeks
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Additional Information
Robyn Sysko, PhD
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place