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NCT06001398: PACT

Parent Acceptance and Commitment Therapy (PACT) for Parents of Children With Pediatric Feeding Disorder

Completed NA Results posted Last updated 15 January 2026
What this trial tests

NA trial testing Parent Acceptance and Commitment Therapy (PACT) in Pediatric Feeding Disorder, Chronic in 30 participants. Completed in 1 December 2025.

Timeline
27 June 2023
Primary endpoint
1 October 2024
1 December 2025

Quick facts

Lead sponsorChildren's Mercy Hospital Kansas City
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeother
Enrollment30
Start date27 June 2023
Primary completion1 October 2024
Estimated completion1 December 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's Mercy Hospital Kansas City

Who can join

Adults 18 to 99, any sex, with Pediatric Feeding Disorder, Chronic or Pediatric Feeding Dysfunction, Acute. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Health Questionnaire-9 (PHQ-9) Primary · Measured 2-week post-intervention

Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depressive symptoms. We used the Reliable Change Index to determine if within-person change was obtained for each participant in the treatment group. Within person change was The Reliable Change Index (RCI) is calculated using a formula that takes into account the pre-test score, post-test score, standard deviation of the test and test-retest reliability coefficient. If the computed within-person value exceeds +/- 1.96 it is considered a significant change. For this study, we then counted the number of partici

Significant Reliable Change Index Score
GroupValue95% CI
Parent Acceptance and Commitment Therapy (PACT)2
Control0
Non-Significant Reliable Change Index Score
GroupValue95% CI
Parent Acceptance and Commitment Therapy (PACT)12
Control0
General Anxiety Disorder Screener (GAD-7) Primary · Measured 2-week post-intervention

The GAD-7 is a 7-item self-report measure of anxious symptoms. We used the Reliable Change Index to determine if within-person change was obtained for each participant in the treatment group. Within person change was The Reliable Change Index (RCI) is calculated using a formula that takes into account the pre-test score, post-test score, standard deviation of the test and test-retest reliability coefficient. If the computed within-person value exceeds +/- 1.96 it is considered a significant change. For this study, we then counted the number of participants who had significant improvements in t

Significant Reliable Change Index Score
GroupValue95% CI
Parent Acceptance and Commitment Therapy (PACT)4
Control0
Non-Significant Reliable Change Index Score
GroupValue95% CI
Parent Acceptance and Commitment Therapy (PACT)10
Control0
Impact of Event Scale - Revised (IES-R) Primary · Measured 2-week post-intervention

The IES-R is a 22-item self-report measure of posttraumatic stress symptoms. We used the Reliable Change Index to determine if within-person change was obtained for each participant in the treatment group. Within person change was The Reliable Change Index (RCI) is calculated using a formula that takes into account the pre-test score, post-test score, standard deviation of the test and test-retest reliability coefficient. If the computed within-person value exceeds +/- 1.96 it is considered a significant change. For this study, we then counted the number of participants who had significant imp

Significant Reliable Change Index Score
GroupValue95% CI
Parent Acceptance and Commitment Therapy (PACT)2
Control0
Non-Significant Reliable Change Index Score
GroupValue95% CI
Parent Acceptance and Commitment Therapy (PACT)12
Control0
Perceived Stress Scale (PSS) Primary · Measured 2-week post-intervention

The PSS is a 10-item self-report measure of perceived stress. We used the Reliable Change Index to determine if within-person change was obtained for each participant in the treatment group. Within person change was The Reliable Change Index (RCI) is calculated using a formula that takes into account the pre-test score, post-test score, standard deviation of the test and test-retest reliability coefficient. If the computed within-person value exceeds +/- 1.96 it is considered a significant change. For this study, we then counted the number of participants who had significant improvements in th

Significant Reliable Change Index Score
GroupValue95% CI
Parent Acceptance and Commitment Therapy (PACT)3
Control0
Non-Significant Reliable Change Index Score
GroupValue95% CI
Parent Acceptance and Commitment Therapy (PACT)11
Control0
Behavioral Pediatrics Feeding Assessment Scale (BPFAS) Primary · Measured 2-week post-intervention

Behavioral Pediatrics Feeding Assessment Scale (Total Frequency Score). The scale has a possible range of 35 to 175, with higher scores indicating worse feeding problems. The BPFAS is a 35-item parent-proxy report of child mealtime and feeding behavior. This was not evaluated using the RCI and instead was only a metric evaluated for pre-post scores in the intervention group as it was an exploratory assessment.

GroupValue95% CI
Parent Acceptance and Commitment Therapy (PACT)88.69± 12.53
Retention Rate Primary · 3-month follow up

This is a measure of the % of participants who were able to be retained from baseline through to the end of the study (3 month follow up). This was assessed as a component of feasibility.

GroupValue95% CI
Parent Acceptance and Commitment Therapy (PACT)14
Control6
Intervention Completion Rate Primary · Intervention Completion (2 week follow up)

This is a measure of the % of participants who started the intervention, and then successfully completed all sessions. This was assessed as a component of feasibility.

GroupValue95% CI
Parent Acceptance and Commitment Therapy (PACT)14
Control6

Sponsor's own description

This is a pilot study of randomized clinical trial of Parent Acceptance and Commitment Therapy (PACT) vs. an attention-control condition (placebo) for improving the mental health of parents of children with pediatric feeding disorder. The goal of this clinical trial is to compare two programs in parents of children with pediatric feeding disorders. The main question\[s\] it aims to answer are: * PACT will result in clinically meaningful reductions in Mental Health(MH) problems among parents of children with Pediatric Feed Disorder (PFD) * Identify factors that impact the feasibility of PACT delivery * Participants will asked to participate in one of two programs focused on parents of children with pediatric feeding disorders. * The participants will also be asked to complete a battery of questionnaires at four timepoints during the study. * The parents will be asked to video record a meal time twice during study. If there is a comparison group: Researchers will compare the PACT group with a control group to see if PACT will result in clinically meaningful change in parent stress and anxiety, and parent use of positive mealtime behaviors.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Stress and Anxiety Screening in Caregivers of Children with Pediatric Feeding Disorder.
    Harris TP, Zax A, Datillo TM, Wallisch A, et al · · 2026 · PMID 41572617 · DOI 10.1177/13591045261418184

Verify or expand the search:

Other recruiting trials for Pediatric Feeding Disorder, Chronic

Currently open trials in the same condition.

Other Children's Mercy Hospital Kansas City trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06001398.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing