Anxiety DisorderNCT03400397
An Effectiveness Study of the Cool Kids Programme
An observational study of Anxiety Disorder, run by Region of Southern Denmark.
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. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Anxiety Disorder
- What is being tested?
- Cool Kids programme
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 1 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- primary diagnose: anxiety or obsessive-compulsive disorder according to ICD-10 criteria (F40-F42; F93)
Who cannot join
- comorbid diagnoses of:
- autism spectrum disorder
- conduct disorder
- untreated or severe ADHD
- low intelligence quotient (IQ)
About this study
Official title: A Naturalistic Effectiveness Study of the Cool Kids Programme in Outpatient Psychiatric Clinics for Children in Southern Jutland, Denmark
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.
Read the 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.
- Conditions
- Anxiety Disorder
- Being tested
- Cool Kids programme
- Keywords
- Anxiety, Child, Cognitive behaviour therapy, CBT, effectiveness, treatment, Cool Kids
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cool Kids programmeOther
A manualised cognitive behavioural treatment programme that consists of 10 session within 12-16 weeks each lasting 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Treatment with the Cool Kids programme. The Cool Kids programme is a manualised cognitive behavioural treatment programme for children with anxiety disorders. Receives: Other: Cool Kids programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, ended treatment (approx. 16-weeks) and 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Sep 2013
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ida Drejer Djurhuus, Region of Southern Denmark
- Investigators
- Ida M Djurhuus, MSc, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400397
- Sponsor's protocol ID
- 16/37580
- Status last verified
- Jan 2018
- First submitted
- 14 Dec 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Naturalistic Effectiveness Study of the Cool Kids Programme in Outpatient Psychiatric Clinics for Children in Southern Jutland, Denmark
- ClinicalTrials.gov ID
- NCT03400397
- Acronym / sponsor ID
- 16/37580
- Conditions
- Anxiety Disorder
- Keywords
- Anxiety, Child, Cognitive behaviour therapy, CBT, effectiveness, treatment, Cool Kids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Region of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: Cool Kids programmeTreatment with the Cool Kids programme. The Cool Kids programme is a manualised cognitive behavioural treatment programme for children with anxiety disorders. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- primary diagnose: anxiety or obsessive-compulsive disorder according to ICD-10 criteria (F40-F42; F93)
Key exclusion criteria (5 listed)
- comorbid diagnoses of:
- autism spectrum disorder
- conduct disorder
- untreated or severe ADHD
- low intelligence quotient (IQ)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cool Kids programmeA manualised cognitive behavioural treatment programme that consists of 10 session within 12-16 weeks each lasting 2 hours. | Other | Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ida M Djurhuus, MSc principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorder, run by Region of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.