Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481072
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-14
Brief Title:
Digital Psychological Intervention for Pediatric Functional Abdominal Pain Disorders in Primary Care
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
Digital Psychological Intervention for Pediatric Functional Abdominal Pain Disorders Through a Collaborative Pathway Between Primary- and Specialist Pediatric Care A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAPD
Brief Summary:
The project involves researching two psychological treatments for functional abdominal pain in children The treatments will be offered to children as an early intervention at primary care level The study will aim to find out if the treatments are effective and which children the different treatments are effective for
Detailed Description:
The research project involves evaluating the efficacy of a collaborative care pathway with a two-level stepped-care model for pediatric FAPD where specialist level community-based pediatric clinics CPC Swedish Barn- och ungdomsmedicinsk mottagning provide consultation and intervention to primary care health centers HC As children with FAPD benefit from early intervention a stepped-care model of delivery at primary care level via a collaborative pathway could potentially be a way to divert more resources to those who need it most The model explores a collaboration whereby an initial diagnosis of FAPD will be made by a general practitioner at a participating HC following which digital interventions with two levels managed by CPC will be provided The aim of the study is to explore the effectiveness of the two levels in the stepped-care model where level 1 involves digitally provided psychoeducation and enhanced information about FAPD and level 2 is a digitally delivered cognitive behavior therapy CBT based psychological intervention for FAPD The CBT intervention is a fully digital version of the Aim to Decrease Anxiety and Pain Treatment ADAPT which has been developed into a Swedish language version through a project funded by the innovation fund in Region Vastragotaland VGR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None