Development of the Aim to Decrease Anxiety and Pain Treatment for Pediatric Functional Abdominal Pain Disorders.
Natoshia R Cunningham, Sarah Nelson, Anjana Jagpal...
https://pubmed.ncbi.nlm.nih.gov/28906315Actively Recruiting
Phase Not Applicable
Age: 8Years - 14Years
All Genders
Healthy Volunteers
ID06481072
Digital Psychological Intervention for Pediatric Functional Abdominal Pain Disorders Through a Collaborative Pathway Between Primary- and Specialist Pediatric Care: A Randomized Clinical Trial
Led by Göteborg University · Updated on 2024-07-01
300
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate two psychological treatments for children aged 8 to 14 with functional abdominal pain disorders (FAPD) at the primary care level. The study focuses on early intervention using a collaborative pathway between primary care health centers and specialist pediatric clinics. It seeks to determine the effectiveness of the treatments and identify which children benefit most from each approach. The study uses a two-level stepped-care model. Level 1 offers digital patient education consisting of six short animated films about pain, FAPD, and basic management strategies. Level 2 adds a fully digital four-session cognitive behavioral therapy (CBT) program called Aim to Decrease Anxiety and Pain Treatment (ADAPT), which includes pain management techniques like relaxation and problem solving. Both interventions are accessed online via a secure platform. Participants will be assessed at baseline, shortly after treatment completion, and again at 6 and 12 months. Researchers will measure changes in pain-related disability, pain intensity, and gastrointestinal symptom-related worry. The study involves digital delivery of treatments and follow-up assessments to observe outcomes over time, helping to understand how these approaches work in real-world primary care settings.
CONDITIONS
Brief Title
Digital Psychological Intervention for Pediatric Functional Abdominal Pain Disorders in Primary Care
Who Can Participate
Age: 8Years - 14Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Children aged 8 to 14 years
- Diagnosed with functional abdominal pain disorders by a physician
- Diagnosis made at one of the participating primary care health centres
You will not qualify if you...
- High scores above clinical cut-off on the Revised Child Anxiety and Depression Scale (RCADS)
- Learning disabilities preventing following the mainstream Swedish National Curriculum
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of the digital intervention period
Participants receive a digital psychological intervention for functional abdominal pain disorders. This includes either digital patient education alone or combined digital patient education and internet-delivered cognitive behavioral therapy (iCBT).
1 baseline visit and multiple digital sessions
Follow-up
Duration - Up to 12 months after intervention completion
Participants are assessed for changes in pain related functional disability, pain intensity, and gastro symptom related worry after intervention completion at multiple timepoints.
3 follow-up visits (within a week after intervention completion, 6 months after, and 12 months after)
Trial Site Locations
Total: 1 location
1
Gothenburg University
Gothenburg, Sweden
Actively Recruiting
Loading map...
Research Team
S
Sandra Weineland, PhD
E
Emma Ramsay Milford, DEdPsy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Psychometric properties of the Revised Child Anxiety and Depression Scale in a clinical sample.
Bruce F Chorpita, Catherine E Moffitt, Jennifer Gray
https://pubmed.ncbi.nlm.nih.gov/15680928Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial.
Natoshia R Cunningham, Anne Kalomiris, James Peugh...
https://pubmed.ncbi.nlm.nih.gov/33130153Functional assessment of pediatric pain patients: psychometric properties of the functional disability inventory.
Robyn Lewis Claar, Lynn S Walker
https://pubmed.ncbi.nlm.nih.gov/16480823Validation of child-adapted short scales for measuring gastrointestinal-specific avoidance and anxiety.
Maria Lalouni, Ola Olén, Johan Bjureberg...
https://pubmed.ncbi.nlm.nih.gov/35545865