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Trial record 71 of 1481 for:    child psychiatry

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

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.

Condition or disease Intervention/treatment
Anxiety Disorder Other: Cool Kids programme

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.


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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Naturalistic Effectiveness Study of the Cool Kids Programme in Outpatient Psychiatric Clinics for Children in Southern Jutland, Denmark
Actual Study Start Date : September 1, 2013
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400397


Sponsors and Collaborators
Region of Southern Denmark
Investigators
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Principal Investigator: Ida M Djurhuus, MSc

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Responsible Party: Ida Drejer Djurhuus, Psychologist / clinical research assistent, Region of Southern Denmark
ClinicalTrials.gov Identifier: NCT03400397     History of Changes
Other Study ID Numbers: 16/37580
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ida Drejer Djurhuus, Region of Southern Denmark:
Anxiety
Child
Cognitive behaviour therapy
CBT
effectiveness
treatment
Cool Kids

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders