Clinical trial NCT03400397: An Effectiveness Study of the Cool Kids Programme
Official title: A Naturalistic Effectiveness Study of the Cool Kids Programme in Outpatient Psychiatric Clinics for Children in Southern Jutland, Denmark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety Disorder
Keywords: Anxiety
Child
Cognitive behaviour therapy
CBT
effectiveness
treatment
Cool Kids
Lead sponsor: Region of Southern Denmark
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 55
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants had all been diagnosed with at least one anxiety or obsessive-compulsive disorder at the specialised child affective team at one of the two outpatient psychiatric clinics.

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in quality of life and level of functioning measured by Child Anxiety Life Interference Scale (CALIS)
timeFrame: baseline, ended treatment (approx. 16-weeks) and 3-months follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Ida M Djurhuus, MSc
role: PRINCIPAL_INVESTIGATOR
References: