ADAPTing CBT for Pediatric Functional Abdominal Pain in Primary Care

ConditionAbdominal Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age9-14

SponsorMichigan State University

About this trial

Many youth experience ongoing stomach pain that does not have a clear medical cause. These conditions, called functional abdominal pain disorders, are common and can last for years. They often interfere with school attendance, daily activities, and social life, and are frequently linked with anxiety. Families may go through many medical tests and appointments without finding relief. The investigator's research shows that teaching these children coping skills, like relaxation, problem solving, and managing anxious thoughts, can reduce pain and improve functioning. The Aim to Decrease Anxiety and Pain Treatment (ADAPT) is a brief program, using cognitive behavioral strategies and mindfulness, the investigators developed that helps children. ADAPT has been shown to work well in specialty clinics, but most children with stomach pain are first seen in primary care, where this type of support is not usually available. The purpose of this project is to test ADAPT in pediatric primary care and test whether it can be delivered successfully. The goal is to improve access to care, reduce symptoms, and better support children.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

FAPD diagnosis

Ages 9-14 years

Functional disability score of 7 or greater

Disqualifiers

<9 years or >14 years

Known developmental disability, sensory, or cognitive impairments that limit youths' ability to engage with behavioral programming

Unmanaged psychiatric illness (e.g., psychosis, active suicidal ideation, severe depression as indicated in electronic medical records)

Symptoms directly attributable to a physical health concern (e.g., cancer, cystic fibrosis, inflammatory bowel disease).

Trial design

Design model

Single group

Treatments tested in this trial

Aim to Decrease Anxiety and Pain Treatment (ADAPT)
Behavioral
Cognitive behavioral intervention for management of pediatric functional abdominal pain, stratified to 4- or 6- sessions depending on presence of anxiety symptoms, offered through primary care

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: ADAPT, cognitive behavioral program for pediatric functional abdominal painExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Recruitment

\>50% agreement to participate

Time frame

At enrollment

Retention rates

\>80% retention

Time frame

From baseline to post assessment (8 weeks)

Feasibility of intervention

responses to semi-structured qualitative post assessment interview

Time frame

at 8 week post assessment

Secondary outcomes

Change in functional disability, measured using the Functional Disability Inventory (FDI)

The 15-item FDI assesses youths' difficulty performing tasks across home, school, recreational, and social settings over the "past few days" due to physical symptoms. Items are rated from 0 ("no trouble") to 4 ("impossible") and summed, yielding total scores of 0-60 with scores ≥7 suggesting greater than minimal disability. Youth will complete a self-report version, and parents will complete an additional version reporting on their child.

Time frame

From baseline to post assessment (8 weeks)

Changes in pain, as measured by the Pain Visual Analog Scale (VAS)

Youth and parents will each report the youth's average pain intensity over the past week using a Visual Analog Scale (VAS). Responses range from 0 (no pain) to 10 (worst imaginable pain), with ratings ≥3 indicating moderate pain.

Time frame

From baseline to post assessment (8 weeks)

Change in anxiety symptoms, measured using the Screen for Child Anxiety Related Disorders (SCARED)

The 41-item Screen for Child Anxiety Related Disorders (SCARED) assesses past 3-month anxiety symptoms. Items are scored on a 3-point Likert-style scale (0 = not true or hardly ever true, 2=very true or often true), and summed to yield total scores of 0-82 with higher scores indicating greater anxiety and scores ≥25 suggesting clinical significance. Youth will complete a self-report version, and parents will complete an additional version reporting on their child.

Time frame

From baseline to post assessment (8 weeks)

Other outcomes

Eating behavior, measured by the Nine Item Avoidant/Restrictive Food Intake Disorder Screen (NIAS)

The Nine Item Avoidant/Restrictive Food Intake Disorder Screen (NIAS) is a self-report questionnaire used to assess symptoms of avoidant/restrictive eating, including picky eating, low appetite, and fear of negative consequences of eating. Items are rated on a Likert-type scale and summed to yield a total score ranging from 0 to 45, with higher scores indicating greater severity of avoidant/restrictive eating symptoms. Youth will complete this measure.

Time frame

From baseline to post-assessment (8 weeks)

Eating behavior, as measured by the Children's Eating Attitudes Test (ChEAT)

The Children's Eating Attitudes Test (ChEAT) is a self-report questionnaire used to assess disordered eating attitudes and behaviors in youth, including dieting, food preoccupation, and concerns about weight. Items are rated on a Likert-type scale and summed to yield a total score ranging from 0 to 78, with higher scores indicating more problematic eating attitudes and greater eating-related concerns. Youth will complete this measure.

Time frame

From baseline to post assessment (8 weeks)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Michigan State University

Lead sponsor

Source ClinicalTrials.gov

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