Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000104550
Ethics application status
Approved
Date submitted
19/01/2015
Date registered
5/02/2015
Date last updated
31/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The CoolKids and Adolescent Health Program:
Helping distressed children & adolescents suffering from somatic health complaints
Scientific title
The CoolKids and Adolescent Health Program: An investigation of a psychological treatment program for distressed youth with functional (medically benign) somatic syndromes reporting somatic and comborbid anxiety and/or depressive symptoms.
Secondary ID [1] 285298 0
Nil
Universal Trial Number (UTN)
U1111-1161-4368
Trial acronym
CK-Health Program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional (medically benign) somatic syndromes 292968 0
Anxiety 292969 0
Depression 292970 0
Condition category
Condition code
Other 293264 293264 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Mental Health 293265 293265 0 0
Anxiety
Mental Health 293266 293266 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Cool Kids and Adolescent Health program is an individual 10 session psychological treatment. The program is administered face to face or via Telephone or Skype. The program runs over 10 x 1 hour weekly sessions.
The program is based on a cognitive and behavioural therapy approach. Children and adolescents will be introduced to:
- Breathing exercises
- Behavioural therapy skills - including exposure/behavioural exercises
- Cognitive therapy and problem-solving skills.

The program is manualized and includes both a child/adolescent and parent workbooks, as parents will be involved in the treatment sessions

The therapy sessions will be conducted by trained psychologists.
Intervention code [1] 290201 0
Treatment: Other
Comparator / control treatment
Participants will be randomly allocated to either the:
1) CoolKids and Adolescent Health program or
2) 10-week wait list control condition.
Control group
Active

Outcomes
Primary outcome [1] 294047 0
Somatic Symptom Disorder - diagnostic status (assessed via ADIS) plus mean scores on Child Somatization Inventory
Timepoint [1] 294047 0
Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion
Primary outcome [2] 294049 0
Anxiety disorder(s) - diagnostic status (assessed via ADIS) plus mean scores on Spence Children's Anxiety Scale
Timepoint [2] 294049 0
Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion
Primary outcome [3] 294050 0
Depression disorder - diagnostic status (assessed via ADIS) plus mean scores on Short Mood Feelings Scale
Timepoint [3] 294050 0
Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion
Secondary outcome [1] 312413 0
Quality of life as assessed using the PEDSQL
Timepoint [1] 312413 0
Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion
Secondary outcome [2] 312415 0
Functional status as assessed using the Functional Disability Inventory
Timepoint [2] 312415 0
Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion
Secondary outcome [3] 312416 0
Emotional regulation as assessed via the Emotional Regulation Questionnaire
Timepoint [3] 312416 0
Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion
Secondary outcome [4] 312417 0
Physical pain as assessed via the Pain Response Inventory for Children
Timepoint [4] 312417 0
Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion
Secondary outcome [5] 312418 0
Life satisfaction as assessed via the Satisfaction with Life Scale
Timepoint [5] 312418 0
Baseline, and at 1-week, 3-months, 6-months and 9-months post-treatment completion

Eligibility
Key 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.
Minimum age
7 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
For any child assessed to be eligible for this trial, following the initial assessment, participants will be allocated to either immediate start or wait-list control via allocation concelament method using centralised randomisation method by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The overall approach to the primary study aims is an experimental 2 x 2 factorial design [Treatment (immediate start vs. wait-list(WL)) x Time (T1-T2)]. Given participants in the WL condition will receive the intervention after the 2nd assessment (following a 10-week wait period), the longer-term follow-ups will assess retention effects for participants who receive the intervention.
Data will be analysed with HLM/mixed models, using repeated measures. Intent-to-treat analyses, using multiple imputations will be conducted. Statistical power is based on the average, moderate effects reported in the limited number of studies that have tested psychological interventions using an RCT design to manage functional somatic syndromes in the paediatric literature. Utilizing a medium effect size with repeated measures, and based on our proposed sample size of N=120 [i.e. N=60 per condition] we have power of .80 to detect significant interactions between conditions.



Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/02/2015
Actual
9/02/2015
Date of last participant enrolment
Anticipated
29/09/2017
Actual
Date of last data collection
Anticipated
30/06/2018
Actual
Sample size
Target
120
Accrual to date
80
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 8677 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 289917 0
University
Name [1] 289917 0
Macquarie University Research Development Grant
Country [1] 289917 0
Australia
Funding source category [2] 293349 0
Charities/Societies/Foundations
Name [2] 293349 0
Rotary Mental Health of Young Australians Research Grant
Country [2] 293349 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University
Balaclava Road, North Ryde,
NSW, 2109
Country
Australia
Secondary sponsor category [1] 289276 0
None
Name [1] 289276 0
Address [1] 289276 0
Country [1] 289276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291636 0
Macquarie University Human Ethics Committee
Ethics committee address [1] 291636 0
Macquarie University
Macquarie University
Balaclava Road, North Ryde,
NSW, 2109
Ethics committee country [1] 291636 0
Australia
Date submitted for ethics approval [1] 291636 0
Approval date [1] 291636 0
17/04/2014
Ethics approval number [1] 291636 0
5201400363

Summary
Brief summary
One-third of youth presenting to GPs and paediatricians complain of physical/somatic problems (e.g., recurring headaches, stomach-aches) that have no physical cause. These complaints are termed functional somatic syndromes (FSS). Importantly, up to 80% of youth with FSS also experience emotional disorders. However, to date, FSS interventions have solely focused on pain management, whilst overlooking the co-occurring anxiety and depressive disturbances. This is problematic given these children are at high-risk for experiencing chronic psychopathology into adulthood.
The aim of this RCT is to test the efficacy of the CoolKids and Adolescent Health (psychological therapy) program which is a newly developed program specifically tailored for distressed children (7-17 years) struggling to cope with somatic-health complaints. Given the CoolKids and Adolescent Health program is also designed to concurrently manage both somatic and anxiety/depression symptoms, it is hypothesized that this program is expected to:
i) lead to significant reductions in somatic, anxiety and depressive symptoms and improvement in quality-of-life compared to a wait-list control group.
ii) The effects will be retained at 6-months and 9-months follow-up.
Trial website
http://centreforemotionalhealth.com.au/pages/healthprogram.aspx
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51278 0
A/Prof Maria Kangas
Address 51278 0
Macquarie University
Centre for Emotional Health
Department of Psychology
Building C3A #717
Ryde NSW 2019
Country 51278 0
Australia
Phone 51278 0
+61298508599
Fax 51278 0
Email 51278 0
[email protected]
Contact person for public queries
Name 51279 0
A/Prof Maria Kangas
Address 51279 0
Macquarie University
Centre for Emotional Health
Department of Psychology
Building C3A #717
Ryde NSW 2019
Country 51279 0
Australia
Phone 51279 0
+61298508599
Fax 51279 0
Email 51279 0
[email protected]
Contact person for scientific queries
Name 51280 0
A/Prof Maria Kangas
Address 51280 0
Macquarie University
Centre for Emotional Health
Department of Psychology
Building C3A #717
Ryde NSW 2019
Country 51280 0
Australia
Phone 51280 0
+61298508599
Fax 51280 0
Email 51280 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.