AnxietyTIMNCT02340637
Coping Kids: Early Intervention for Anxiety and Depression
A study testing Coping Kids and TAU in people with Anxiety and Depression, run by Regionsenter for barn og unges psykiske helse at 3 sites in Norway.
Trial summary
The purpose of this study is to provide knowledge regarding the effect of early intervention and prevention on the development of anxiety and depression in children. The focus of the intervention is to reduce symptoms of anxiety and depression and help children develop skills to enhance self-esteem in order to improve… Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Coping Kids and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 873 participants
- Where
- 3 sitesNorway
- Study dates
- 3 Mar 2014to Jul 2017
- Phase
- Interventional
- 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children at the intervention schools indicating a symptom level of, at minimum, one standard deviation above mean on anxiety and/or depression on self-report measures will be offered participation in an intervention group
Who cannot join
- Children who for different reasons may not benefit from a group-process intervention (e.g. mental retardation) will be considered individually and the reasons for exclusion will be documented in the Consort flow-chart.
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Regionsenter for barn og unges psykiske helse
Oslo, 0484
Regional kunnskapssenter for barn og unge - Nord
Tromsø, 9037
Regional kunnskapssenter for barn og unge - Midt
Trondheim, 7491
About this study
Official title: Coping Kids: A Randomized Controlled Study of a New Indicated Preventive Intervention for Children With Symptoms of Anxiety and Depression
The purpose of this study is to provide knowledge regarding the effect of early intervention and prevention on the development of anxiety and depression in children. The focus of the intervention is to reduce symptoms of anxiety and depression and help children develop skills to enhance self-esteem in order to improve life quality. Gender and ethnicity will be studied as moderating factors. Primary care givers will be trained in the use of evidence based methods for children with internalizing difficulties. Children in need will be identified and receive improved services, based on international standards. Active collaboration will be established nationally between three Centers for child and adolescent mental health (RKBU/RBUP) and internationally with Philip C. Kendall at the Temple University in Philadelphia and Kevin Stark at University of Texas at Austin.
Primary aims are to examine if an indicated group and school based program, Coping Kids, is more effective than treatment as usual (TAU) in reducing high levels of symptoms of both anxiety and depression among 8-12 year old schoolchildren, and if the the effects are stable over 12 months.
- Conditions
- Anxiety, Depression
- Being tested
- Coping Kids, TAU
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping KidsBehavioural
Also called TIM
The first half (10 sessions) of Coping Kids focuses on building skills that are common to both anxiety and depression. The children practice strategies to regulate their mood, learn problem-solving, and behavioral activation is used to break the cycle of withdrawal. The second half of Coping Kids (10 sessions) is focused on the youth's specific problem; for depressive symptoms, building a positive self-schema and behavioral activation; for anxiety problems, gradual exposure to fear-inducing situations. Cognitive restructuring directed at different maladaptive thoughts is also emphasized.
TAUBehavioural
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Coping Kids | Experimental | A Program for Managing Anxiety and Depression (P.C Kendall et al., 2013) is a newly developed group intervention targeting children aged 8 to 13 years who experience difficulty with symptoms of anxiety, depression, or both. The program is designed as an indicated prevention intervention to reduce the symptom levels and reduce the likelihood of the development of an anxiety disorder and/or depression.
The youth-focused sessions are designed for implementation in school settings, and the program includes parent group meetings.
All groupleaders participate in a three days training, followed by supervision. Manuals and workbooks are provided by the project. In addition is the same presentation as in TAU offered to the schools. Receives: Behavioral: Coping Kids |
| TAU | Active comparator | The teachers and school-nurses in the control schools will conduct treatment as usual (TAU).The project offers a 2,5 hours presentation to the schools, providing general information about the research study, the prevalence of emotional disorders and how to handle emotional disorders in treatment as usual. No materials are provided by the project. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
MASC-C (Multidimensional Anxiety Scale for Children)
Children: (1) MASC-C (March, 1997): A 40- items self-report assessing change in anxiety in children and adolescents between 8 and 19 years.
Measured: baseline, 10 weeks, 12 month
MFQ (Mood and Feelings Questionnaire-short version)
Children: (2) MFQ short Version (Angold et al., 1994): A 13-items measure assessing change in cognitive, affective and behavioral-related symptoms of depression in children 8 to 18 years, with one added question about suicidality.
Measured: baseline, 10 weeks, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study start3 Mar 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 873 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionsenter for barn og unges psykiske helse
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Regional kunnskapssenter for barn og unge - Midt, Regional kunnskapssenter for barn og unge - Nord
- Responsible party
- Principal investigator, Simon-Peter Neumer, Regionsenter for barn og unges psykiske helse
- Investigators
- Simon-Peter Neumer, Dr. phil, Principal investigator, Regionsenter for barn og unge psykiske helse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340637
- Sponsor's protocol ID
- 228846/H10
- Acronym
- TIM
- Status last verified
- May 2020
- First submitted
- 12 Jun 2014
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Patras J, Martinsen KD, Holen S, Sund AM, Adolfsen F, Rasmussen LP, Neumer SP. Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression. BMC Psychol. 2016 Sep 26;4(1):48. doi: 10.1186/s40359-016-0155-y.
PubMed 27671742Martinsen KD, Neumer SP, Holen S, Waaktaar T, Sund AM, Kendall PC. Self-reported quality of life and self-esteem in sad and anxious school children. BMC Psychol. 2016 Sep 13;4(1):45. doi: 10.1186/s40359-016-0153-0.
PubMed 27624487Pedersen ML, Jozefiak T, Sund AM, Holen S, Neumer SP, Martinsen KD, Rasmussen LMP, Patras J, Lydersen S. Psychometric properties of the Brief Problem Monitor (BPM) in children with internalizing symptoms: examining baseline data from a national randomized controlled intervention study. BMC Psychol. 2021 Nov 27;9(1):185. doi: 10.1186/s40359-021-00689-1.
PubMed 34838153Rasmussen LP, Patras J, Handegard BH, Neumer SP, Martinsen KD, Adolfsen F, Sund AM, Martinussen M. Evaluating Delivery of a CBT-Based Group Intervention for Schoolchildren With Emotional Problems: Examining the Reliability and Applicability of a Video-Based Adherence and Competence Measure. Front Psychol. 2021 Jun 28;12:702565. doi: 10.3389/fpsyg.2021.702565. eCollection 2021.
PubMed 34262514Martinsen KD, Rasmussen LP, Wentzel-Larsen T, Holen S, Sund AM, Pedersen ML, Lovaas MES, Patras J, Adolfsen F, Neumer SP. Change in quality of life and self-esteem in a randomized controlled CBT study for anxious and sad children: can targeting anxious and depressive symptoms improve functional domains in schoolchildren? BMC Psychol. 2021 Jan 21;9(1):8. doi: 10.1186/s40359-021-00511-y.
PubMed 33478593Loevaas MES, Lydersen S, Sund AM, Neumer SP, Martinsen KD, Holen S, Patras J, Adolfsen F, Rasmussen LP, Reinfjell T. A 12-month follow-up of a transdiagnostic indicated prevention of internalizing symptoms in school-aged children: the results from the EMOTION study. Child Adolesc Psychiatry Ment Health. 2020 Apr 22;14:15. doi: 10.1186/s13034-020-00322-w. eCollection 2020.
PubMed 32336987Pedersen ML, Holen S, Lydersen S, Martinsen K, Neumer SP, Adolfsen F, Sund AM. School functioning and internalizing problems in young schoolchildren. BMC Psychol. 2019 Dec 23;7(1):88. doi: 10.1186/s40359-019-0365-1.
PubMed 31870462
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping Kids: A Randomized Controlled Study of a New Indicated Preventive Intervention for Children With Symptoms of Anxiety and Depression
- ClinicalTrials.gov ID
- NCT02340637
- Acronym / sponsor ID
- TIM / 228846/H10
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 873 participants (actual)
- Lead sponsor
- Regionsenter for barn og unges psykiske helseUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Regional kunnskapssenter for barn og unge - Midt, Regional kunnskapssenter for barn og unge - Nord
- Study start
- 3 Mar 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 16 Jan 2015 (estimated)
- 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 purpose of this study is to provide knowledge regarding the effect of early intervention and prevention on the development of anxiety and depression in children. The focus of the intervention is to reduce symptoms of anxiety and depression and help children develop skills to enhance self-esteem in order to improve life quality. Gender and ethnicity will be studied as moderating factors. Primary care givers will be trained in the use of evidence based methods for children with internalizing difficulties. Children in need will be identified and receive improved services, based on international standards. Active collaboration will be established nationally between three Centers for child and adolescent mental health (RKBU/RBUP) and internationally with Philip C. Kendall at the Temple University in Philadelphia and Kevin Stark at University of Texas at Austin.
Primary aims are to examine if an indicated group and school based program, Coping Kids, is more effective than treatment as usual (TAU) in reducing high levels of symptoms of both anxiety and depression among 8-12 year old schoolchildren, and if the the effects are stable over 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coping Kids | Experimental | Behavioral: Coping KidsA Program for Managing Anxiety and Depression (P.C Kendall et al., 2013) is a newly developed group intervention targeting children aged 8 to 13 years who experience difficulty with symptoms of anxiety, depression, or both. The program is designed as an indicated prevention intervention to reduce the symptom levels and reduce the likelihood of the development of an anxiety disorder and/or depression. The youth-focused sessions are designed for implementation in school settings, and the program includes parent group meetings. All groupleaders participate in a three days training, followed by supervision. Manuals and workbooks are provided by the project. In addition is the same presentation as in TAU offered to the schools. |
| TAU | Active comparator | Behavioral: TAUThe teachers and school-nurses in the control schools will conduct treatment as usual (TAU).The project offers a 2,5 hours presentation to the schools, providing general information about the research study, the prevalence of emotional disorders and how to handle emotional disorders in treatment as usual. No materials are provided by the project. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children at the intervention schools indicating a symptom level of, at minimum, one standard deviation above mean on anxiety and/or depression on self-report measures will be offered participation in an intervention group
Key exclusion criteria (1 listed)
- Children who for different reasons may not benefit from a group-process intervention (e.g. mental retardation) will be considered individually and the reasons for exclusion will be documented in the Consort flow-chart.
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 |
|---|---|---|
| Coping KidsAlso: TIMThe first half (10 sessions) of Coping Kids focuses on building skills that are common to both anxiety and depression. The children practice strategies to regulate their mood, learn problem-solving, and behavioral activation is used to break the cycle of withdrawal. The second half of Coping Kids (10 sessions) is focused on the youth's specific problem; for depressive symptoms, building a positive self-schema and behavioral activation; for anxiety problems, gradual exposure to fear-inducing situations. Cognitive restructuring directed at different maladaptive thoughts is also emphasized. | Behavioural | Coping Kids |
| TAUTreatment as usual | Behavioural | TAU |
Primary outcome
MASC-C (Multidimensional Anxiety Scale for Children)
Time frame: baseline, 10 weeks, 12 month
Children: (1) MASC-C (March, 1997): A 40- items self-report assessing change in anxiety in children and adolescents between 8 and 19 years.
MFQ (Mood and Feelings Questionnaire-short version)
Time frame: baseline, 10 weeks, 12 months
Children: (2) MFQ short Version (Angold et al., 1994): A 13-items measure assessing change in cognitive, affective and behavioral-related symptoms of depression in children 8 to 18 years, with one added question about suicidality.
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 18 May 2020.
- Results publication: PubMed 27671742Patras J, Martinsen KD, Holen S, Sund AM, Adolfsen F, Rasmussen LP, Neumer SP. Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression. BMC Psychol. 2016 Sep 26;4(1):48. doi: 10.1186/s40359-016-0155-y.
- Results publication: PubMed 27624487Martinsen KD, Neumer SP, Holen S, Waaktaar T, Sund AM, Kendall PC. Self-reported quality of life and self-esteem in sad and anxious school children. BMC Psychol. 2016 Sep 13;4(1):45. doi: 10.1186/s40359-016-0153-0.
- Derived from this study: PubMed 34838153Pedersen ML, Jozefiak T, Sund AM, Holen S, Neumer SP, Martinsen KD, Rasmussen LMP, Patras J, Lydersen S. Psychometric properties of the Brief Problem Monitor (BPM) in children with internalizing symptoms: examining baseline data from a national randomized controlled intervention study. BMC Psychol. 2021 Nov 27;9(1):185. doi: 10.1186/s40359-021-00689-1.
- Derived from this study: PubMed 34262514Rasmussen LP, Patras J, Handegard BH, Neumer SP, Martinsen KD, Adolfsen F, Sund AM, Martinussen M. Evaluating Delivery of a CBT-Based Group Intervention for Schoolchildren With Emotional Problems: Examining the Reliability and Applicability of a Video-Based Adherence and Competence Measure. Front Psychol. 2021 Jun 28;12:702565. doi: 10.3389/fpsyg.2021.702565. eCollection 2021.
- Derived from this study: PubMed 33478593Martinsen KD, Rasmussen LP, Wentzel-Larsen T, Holen S, Sund AM, Pedersen ML, Lovaas MES, Patras J, Adolfsen F, Neumer SP. Change in quality of life and self-esteem in a randomized controlled CBT study for anxious and sad children: can targeting anxious and depressive symptoms improve functional domains in schoolchildren? BMC Psychol. 2021 Jan 21;9(1):8. doi: 10.1186/s40359-021-00511-y.
- Derived from this study: PubMed 32336987Loevaas MES, Lydersen S, Sund AM, Neumer SP, Martinsen KD, Holen S, Patras J, Adolfsen F, Rasmussen LP, Reinfjell T. A 12-month follow-up of a transdiagnostic indicated prevention of internalizing symptoms in school-aged children: the results from the EMOTION study. Child Adolesc Psychiatry Ment Health. 2020 Apr 22;14:15. doi: 10.1186/s13034-020-00322-w. eCollection 2020.
- Derived from this study: PubMed 31870462Pedersen ML, Holen S, Lydersen S, Martinsen K, Neumer SP, Adolfsen F, Sund AM. School functioning and internalizing problems in young schoolchildren. BMC Psychol. 2019 Dec 23;7(1):88. doi: 10.1186/s40359-019-0365-1.
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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.
Simon-Peter Neumer, Dr. phil principal investigator
Regionsenter for barn og unge psykiske helse
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping Kids and TAU in people with Anxiety and Depression, run by Regionsenter for barn og unges psykiske helse at 3 sites in Norway.
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 1 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 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
MASC-C (Multidimensional Anxiety Scale for Children) (time frame: baseline, 10 weeks, 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02340637, which also lists 7 linked publications.
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 18 May 2020.