Trial Outcomes & Findings for Parent Acceptance and Commitment Therapy (PACT) for Parents of Children With Pediatric Feeding Disorder (NCT NCT06001398)

NCT ID: NCT06001398

Last Updated: 2026-01-15

Results Overview

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 participants who had significant improvements in this outcome variable compared to those who did not.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Measured 2-week post-intervention
• Results posted on: 2026-01-15

Participant Flow

Participant milestones

Measure	Parent Acceptance and Commitment Therapy (PACT) PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature.	Control The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate.
Overall Study STARTED	20	10
Overall Study COMPLETED	14	6
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Parent Acceptance and Commitment Therapy (PACT) n=14 Participants PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature.	Control n=6 Participants The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate.	Total n=20 Participants Total of all reporting groups
Age, Continuous	35.5 years STANDARD_DEVIATION 8.39 • n=14 Participants	31 years STANDARD_DEVIATION 6.66 • n=10 Participants	34 years STANDARD_DEVIATION 7.96 • n=24 Participants
Sex/Gender, Customized Female	13 Participants n=14 Participants	6 Participants n=10 Participants	19 Participants n=24 Participants
Sex/Gender, Customized Male	1 Participants n=14 Participants	0 Participants n=10 Participants	1 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	1 Participants n=10 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Black or African American	2 Participants n=14 Participants	0 Participants n=10 Participants	2 Participants n=24 Participants
Race (NIH/OMB) White	12 Participants n=14 Participants	5 Participants n=10 Participants	17 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=14 Participants	0 Participants n=10 Participants	1 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=14 Participants	6 Participants n=10 Participants	19 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
PHQ9	6.57 Rating Scale STANDARD_DEVIATION 4.48 • n=14 Participants	7.33 Rating Scale STANDARD_DEVIATION 3.56 • n=10 Participants	6.80 Rating Scale STANDARD_DEVIATION 4.15 • n=24 Participants
GAD7	8.64 Rating Scale STANDARD_DEVIATION 4.85 • n=14 Participants	8.83 Rating Scale STANDARD_DEVIATION 3.66 • n=10 Participants	8.70 Rating Scale STANDARD_DEVIATION 4.43 • n=24 Participants
PSS	21.21 Rating Scale STANDARD_DEVIATION 5.24 • n=14 Participants	18.83 Rating Scale STANDARD_DEVIATION 4.71 • n=10 Participants	20.50 Rating Scale STANDARD_DEVIATION 5.08 • n=24 Participants
IESR	23.93 Rating Scale STANDARD_DEVIATION 19.99 • n=14 Participants	22.17 Rating Scale STANDARD_DEVIATION 18.43 • n=10 Participants	23.40 Rating Scale STANDARD_DEVIATION 19.07 • n=24 Participants
BPFAS	91 Rating Scale STANDARD_DEVIATION 11.49 • n=14 Participants	96.14 Rating Scale STANDARD_DEVIATION 14.10 • n=10 Participants	92.5 Rating Scale STANDARD_DEVIATION 12.22 • n=24 Participants

PRIMARY outcome

Timeframe: Measured 2-week post-intervention

Population: This outcome measure is only assessed in the active treatment group as it was pre-specified that this data is only pertinent to the active treatment group being assessed. This was a proof of concept study and the control group was only completed for feasibility/acceptability evaluation.

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 participants who had significant improvements in this outcome variable compared to those who did not.

Outcome measures

Measure	Parent Acceptance and Commitment Therapy (PACT) n=14 Participants PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature.	Control The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate.
Patient Health Questionnaire-9 (PHQ-9) Significant Reliable Change Index Score	2 Participants	0 Participants
Patient Health Questionnaire-9 (PHQ-9) Non-Significant Reliable Change Index Score	12 Participants	0 Participants

PRIMARY outcome

Timeframe: Measured 2-week post-intervention

Population: This outcome measure is only assessed in the active treatment group as it was pre-specified that this data is only pertinent to the active treatment group being assessed. This was a proof of concept study and the control group was only completed for feasibility/acceptability evaluation.

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 this outcome variable compared to those who did not.

Outcome measures

Measure	Parent Acceptance and Commitment Therapy (PACT) n=14 Participants PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature.	Control The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate.
General Anxiety Disorder Screener (GAD-7) Significant Reliable Change Index Score	4 Participants	0 Participants
General Anxiety Disorder Screener (GAD-7) Non-Significant Reliable Change Index Score	10 Participants	0 Participants

PRIMARY outcome

Timeframe: Measured 2-week post-intervention

Population: This outcome measure is only assessed in the active treatment group as it was pre-specified that this data is only pertinent to the active treatment group being assessed. This was a proof of concept study and the control group was only completed for feasibility/acceptability evaluation.

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 improvements in this outcome variable compared to those who did not.

Outcome measures

Measure	Parent Acceptance and Commitment Therapy (PACT) n=14 Participants PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature.	Control The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate.
Impact of Event Scale - Revised (IES-R) Significant Reliable Change Index Score	2 Participants	0 Participants
Impact of Event Scale - Revised (IES-R) Non-Significant Reliable Change Index Score	12 Participants	0 Participants

PRIMARY outcome

Timeframe: Measured 2-week post-intervention

Population: This outcome measure is only assessed in the active treatment group as it was pre-specified that this data is only pertinent to the active treatment group being assessed. This was a proof of concept study and the control group was only completed for feasibility/acceptability evaluation.

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 this outcome variable compared to those who did not.

Outcome measures

Measure	Parent Acceptance and Commitment Therapy (PACT) n=14 Participants PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature.	Control The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate.
Perceived Stress Scale (PSS) Significant Reliable Change Index Score	3 Participants	0 Participants
Perceived Stress Scale (PSS) Non-Significant Reliable Change Index Score	11 Participants	0 Participants

PRIMARY outcome

Timeframe: Measured 2-week post-intervention

Population: This outcome measure is only assessed in the active treatment group as it was pre-specified that this data is only pertinent to the active treatment group being assessed. This was a proof of concept study and the control group was only completed for feasibility/acceptability evaluation.

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.

Outcome measures

Measure	Parent Acceptance and Commitment Therapy (PACT) n=14 Participants PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature.	Control The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate.
Behavioral Pediatrics Feeding Assessment Scale (BPFAS)	88.69 Rating Scale Standard Deviation 12.53	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Parent Acceptance and Commitment Therapy (PACT) n=20 Participants PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature.	Control n=10 Participants The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate.
Retention Rate	14 Participants	6 Participants

PRIMARY outcome

Timeframe: Intervention Completion (2 week follow up)

Population: For participants who began the first session of the intervention (n=14 in the PACT arm, n=6 in the Control arm), this is the number of participants who subsequently completed both intervention sessions in full.

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.

Outcome measures

Measure	Parent Acceptance and Commitment Therapy (PACT) n=14 Participants PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature.	Control n=6 Participants The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate.
Intervention Completion Rate	14 Participants	6 Participants

Adverse Events

Parent Acceptance and Commitment Therapy (PACT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dana Bakula, PhD

Children's Mercy Kansas City

Phone: (816) 302-3069

Email: dmbakula@cmh.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place