An Effectiveness Study of the Cool Kids Programme

Anxiety Disorder Clinical Trial

Official title:

A Naturalistic Effectiveness Study of the Cool Kids Programme in Outpatient Psychiatric Clinics for Children in Southern Jutland, Denmark

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400397
• Other study ID #: 16/37580
• Status: Completed
• Phase: N/A
• First received: December 14, 2017
• Last updated: January 9, 2018
• Start date: September 1, 2013
• Est. completion date: December 1, 2016

Study information

• Verified date: January 2018
• Source: Region of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the present study is to investigate the effectiveness of the Cool Kids programme after implementation in two outpatient psychiatric clinics for children in Southern Jutland, Denmark. The Cool Kids programme is a manualised cognitive behavioural treatment programme for children aged 6 to 12 years with anxiety disorders. Previous efficacy studies have found that 60-80% of all children who complete the program show marked improvement. However, only one previous effectiveness study has ever been conducted. It is therefore relevant to examine whether the previously mentioned effect is maintained when the programme is implemented in a healthcare setting rather than a research setting.

Description:

The study was conducted at two outpatient psychiatric clinics for children in Southern Jutland, Denmark.

Data was gathered from 55 patients who completed the Cool Kids programme as a treatment for anxiety disorder(s) from autumn 2013 to spring 2016. During the course of treatment both children and parents completed the Child Anxiety Life Interference Scale (CALIS) at baseline, post-treatment and at a 3-months follow-up booster-session. This data was originally gathered for internal quality assessment at the clinics. As the data was utilized for the present study in 2017, it has not been possible to control for confounding factors or influence the data-collection process.

All questionnaires were anonymised previous to being manually scored and keyed for secured electronic storage. Participants were excluded from the data analysis if they had one or more incomplete or missing CALIS. All statistical analysis was carried out in IBM SPSS 24 Statistical Software and consists of linear mixed effect models and one-way repeated measures ANOVAs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

Inclusion Criteria:

• primary diagnose: anxiety or obsessive-compulsive disorder according to ICD-10 criteria (F40-F42; F93)

Exclusion Criteria:

• comorbid diagnoses of:

• autism spectrum disorder

• conduct disorder

• untreated or severe ADHD

• low intelligence quotient (IQ)

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders

Intervention

Other:
• Cool Kids programme
A manualised cognitive behavioural treatment programme that consists of 10 session within 12-16 weeks each lasting 2 hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region of Southern Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life and level of functioning measured by Child Anxiety Life Interference Scale (CALIS)	Child Anxiety Life Interference Scale (CALIS) is a questionnaire that measures the degree of interference in level of functioning and quality of life caused by anxiety symptoms in 6- to 17-year-olds and their parents. CALIS is a scale for tracking treatment change.; There are two versions of CALIS: a self-report questionnaire, and a parent-report questionnaire.; All questions are answered on a 5-point Likert-scale with the choices: (0) Not at all, (1) Only a little, (2) Sometimes, (3) Quite a lot, and (4) A great deal. CALIS consists of 9 items in the self-report version and 16 items in the parent-report version split with respectively 9 and 7 items for interference in the child's and the parents' life. The self-report and parent-report scales for interference in the child's life is divided into two subscales: Outside Home (5 items) and At Home (4 items). The higher the score, the greater interference caused by anxiety symptoms.	baseline, ended treatment (approx. 16-weeks) and 3-months follow-up