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Written Self-disclosure for Youth Abdominal Pain

RCT of Written Self-disclosure for Youth Abdominal Pain

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00062608
Enrollment
160
Registered
2003-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2010-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain

Keywords

Abdominal

Brief summary

The aims are to evaluate: (1) the effectiveness of written self-disclosure (WSD) on health status of youth ages 12-18 with functional recurrent abdominal pain (RAP); (2) whether effectiveness of WSD is similar for younger (12-14) and older (15-18) youth with functional RAP; and (3) the feasibility and acceptability of WSD when extended to the pediatric health care setting.We will implement a randomized, controlled trial (RCT) designed to compare health status in 140 youths (ages 12-18) with functional RAP assigned either to standard medical care (SMC) or WSD provided in the health care setting in addition to SMC. Health status will be measured at Baseline and 3- and 6-months thereafter. Primary measures of health status are symptom severity and episode frequency, consistent with the definition of RAP. Secondary measures of health are functional health, psychological distress, health-related quality of life, and health care utilization. Total use and diagnostic tests will index health care utilization, collected for the 6-mos prior to and following Baseline. Mixed model ANOVA or MANOVA will be used to test directional hypotheses corresponding to the specific aims.

Interventions

BEHAVIORALWritten self-disclosure

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Ages 12-18. * Diagnosis of RAP by the examining pediatric gastroenterologist using Apley's (1975) criteria: (a) 3 episodes of abdominal pain, (b) severe enough to interrupt activities and occurring, (c) over a period of at least 3 months, (d) without an identifiable organic cause (If an organic cause is identified during participation in protocol, then participant is withdrawn from database prior to analysis). * Free of a known chronic health condition. * Physical and mental ability to complete the procedures, as judged by Dr. Madan-Swain. * Consents to complete the protocol over the next 6 months. * Parent(s) consents to participate and agrees to support the youth in completing the protocol. * Access to a phone on the days writing sessions are to be completed at home.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026