An Effectiveness Study of the Cool Kids Programme

NCT03400397 | Completed

• 1 other identifier: 16/37580
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety Disorder

Keywords

Anxiety; Child; Cognitive behaviour therapy; CBT; effectiveness; treatment; Cool Kids

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intervention

Treatment with the Cool Kids programme. The Cool Kids programme is a manualised cognitive behavioural treatment programme for children with anxiety disorders.

Other: Cool Kids programme

Interventions

Cool Kids programme OTHER

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

Intervention

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• comorbid diagnoses of:
• autism spectrum disorder
• conduct disorder
• untreated or severe ADHD
• low intelligence quotient (IQ)

Sponsors & Collaborators

• Region of Southern Denmark: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ida M Djurhuus, MSc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist / clinical research assistent

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 17, 2018
• Study Start: September 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share