The CoolKids and Adolescent Health Program:Helping distressed children & adolescents suffering from somatic health complaints

Not Applicable

Recruiting

• Conditions: Functional (medically benign) somatic syndromes; Anxiety; Depression; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis); Mental Health - Anxiety; Mental Health - Depression

• Registration Number: ACTRN12615000104550
• Lead Sponsor: Macquarie University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

i) aged 7 to 17 years at referral;
ii) General Practitioner (GP) or medical specialist (e.g., gastro-enterologist, neurologist, cardiologist etc) verification via documented referral report of recurrent somatic problems with no organic cause for a minimum duration of 3-months;
iii) meeting clinical sub-threshold or full diagnostic criteria for at least one type of anxiety and/or depressive disorder [verified at screening assessment via DSM-ADIS-C/P diagnostic interview with minimum clinician severity rating score of 3 or > (as assessed by clinical psychologists/employed as personnel for this project)];
iv) children on medication (e.g., antiacids) or psychiatric medications for a min. of 3 months will be included, provided they remain on stable dosage throughout the study program period;
v) able to read and write basic English; and
vi) one of the parent/guardians is committed to attending therapy sessions.

Exclusion Criteria

i) not receiving alternate psychological treatment at time of referral or during the course of the study;
ii) current suicidal ideation; and
iii) intellectually impaired.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Somatic Symptom Disorder - diagnostic status (assessed via ADIS) plus mean scores on Child Somatization Inventory[Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion];Anxiety disorder(s) - diagnostic status (assessed via ADIS) plus mean scores on Spence Children's Anxiety Scale[Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion];Depression disorder - diagnostic status (assessed via ADIS) plus mean scores on Short Mood Feelings Scale[Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion]

Secondary Outcome Measures

Name	Time	Method
Quality of life as assessed using the PEDSQL[Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion];Functional status as assessed using the Functional Disability Inventory[Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion];Emotional regulation as assessed via the Emotional Regulation Questionnaire[Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion];Physical pain as assessed via the Pain Response Inventory for Children[Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion];Life satisfaction as assessed via the Satisfaction with Life Scale[Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion]