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An Effectiveness Study of the Cool Kids Programme

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ClinicalTrials.gov Identifier: NCT03400397
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ida Drejer Djurhuus, Region of Southern Denmark

Tracking Information
First Submitted Date December 14, 2017
First Posted Date January 17, 2018
Last Update Posted Date January 17, 2018
Actual Study Start Date September 1, 2013
Actual Primary Completion Date December 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2018)
Change in quality of life and level of functioning measured by Child Anxiety Life Interference Scale (CALIS) [ Time Frame: baseline, ended treatment (approx. 16-weeks) and 3-months follow-up ]
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Anxiety Disorder
Intervention Other: Cool Kids programme
A manualised cognitive behavioural treatment programme that consists of 10 session within 12-16 weeks each lasting 2 hours.
Study Groups/Cohorts Intervention
Treatment with the Cool Kids programme. The Cool Kids programme is a manualised cognitive behavioural treatment programme for children with anxiety disorders.
Intervention: Other: Cool Kids programme
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 9, 2018)
55
Original Actual Enrollment Same as current
Actual Study Completion Date December 1, 2016
Actual Primary Completion Date December 1, 2016   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 13 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03400397
Other Study ID Numbers 16/37580
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ida Drejer Djurhuus, Region of Southern Denmark
Study Sponsor Region of Southern Denmark
Collaborators Not Provided
Investigators
Principal Investigator: Ida M Djurhuus, MSc
PRS Account Region of Southern Denmark
Verification Date January 2018