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Early Intervention Coping Kids (TIM) Follow up Study (FOPPT4)

Primary Purpose

Anxiety Disorders, Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EMOTION Kids coping with anxiety and depression (Kendall et. al, 2013) (Mestrende barn in Norwegian) Martinsen et al, 2014
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Disorders focused on measuring Anxiety, Depression, school absentism, youth

Eligibility Criteria

13 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants who participated in the previous randomized controlled TIM study Exclusion Criteria: all participats may enter the follow up study but participants who chose withdraw from the follow-up study of the TIM study are excluded -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Intervention arm

    Control arm

    Arm Description

    Youth in this arm received the intervention over 10 weeks during one semester (recruiting children over 6 semesters in total), children meeting in groups of approx. seven children. The groups were led by school health nurses. At the same time parents met for 7 group sessions, with the children participating in four of these

    The youth in the control condition received treatment as usual, e.g. talks with school health nurses or no intervention

    Outcomes

    Primary Outcome Measures

    Multidimensional anxiety scale for children - MASC C/P (March, 1997)
    This 39-item, child self-report, assesses anxiety in youth ages 8 - 19
    The Mood and Feelings Questionnaire Short version (SMFQ:Angold et al., 1995)
    SMFQ comprised of 13 questions assessing cognitive, affective and behavioral-related depressive symptoms in youth ages 8 - 18 during the last two weeks
    The ADIS (Anxiety Disorders Interview Schedule (Albano & Silverman, 2010)
    Relevant sections of this semi-structured interview (anxiety and depression)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 1, 2023
    Last Updated
    March 1, 2023
    Sponsor
    University of Oslo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05766072
    Brief Title
    Early Intervention Coping Kids (TIM) Follow up Study
    Acronym
    FOPPT4
    Official Title
    5 Year- Follow up of Anxious and Sad Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 31, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Oslo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The project objectives are to investigate if a preventive intervention targeting anxious and sad children aged 8 to 12 years has haf the anticipated long-term effects, 5 years after receiving the intervention. Hence: will an indicated intervention reduce the incidence of common mental disorders in youth in the long term? The current study is a 5 year follow up of the previously completed RCT called the TIM-study (Clinical Trials identifier: NCT 02340637), se also Patras et al, 2016. The aim of this study is to determine the long-term effects of the intervention to examine if true preventive effects are achieved as indicated by lower symptom levels, better functioning og fewer diagnosis of anxiety and depression 5 years after receiving an indicated preventiv intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorders, Depression
    Keywords
    Anxiety, Depression, school absentism, youth

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    450 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention arm
    Arm Type
    Active Comparator
    Arm Description
    Youth in this arm received the intervention over 10 weeks during one semester (recruiting children over 6 semesters in total), children meeting in groups of approx. seven children. The groups were led by school health nurses. At the same time parents met for 7 group sessions, with the children participating in four of these
    Arm Title
    Control arm
    Arm Type
    No Intervention
    Arm Description
    The youth in the control condition received treatment as usual, e.g. talks with school health nurses or no intervention
    Intervention Type
    Other
    Intervention Name(s)
    EMOTION Kids coping with anxiety and depression (Kendall et. al, 2013) (Mestrende barn in Norwegian) Martinsen et al, 2014
    Intervention Description
    The intervention is transdiagnostic and based on cognitive behavioral therapy where the children and their parents meet i groups led of school health nurses. They are learning coping skills to meet challenging and avoided situations, learning about emotion regulation, physical symptoms conitive restructuring and exposure/behavioral activation. Te manual is publshed in a US/English version and in a Norwegian version.
    Primary Outcome Measure Information:
    Title
    Multidimensional anxiety scale for children - MASC C/P (March, 1997)
    Description
    This 39-item, child self-report, assesses anxiety in youth ages 8 - 19
    Time Frame
    5- year follow up
    Title
    The Mood and Feelings Questionnaire Short version (SMFQ:Angold et al., 1995)
    Description
    SMFQ comprised of 13 questions assessing cognitive, affective and behavioral-related depressive symptoms in youth ages 8 - 18 during the last two weeks
    Time Frame
    5-year follow up
    Title
    The ADIS (Anxiety Disorders Interview Schedule (Albano & Silverman, 2010)
    Description
    Relevant sections of this semi-structured interview (anxiety and depression)
    Time Frame
    5-year follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants who participated in the previous randomized controlled TIM study Exclusion Criteria: all participats may enter the follow up study but participants who chose withdraw from the follow-up study of the TIM study are excluded -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kristin D. Oslo, PhD
    Phone
    +479586031
    Email
    k.d.martinsen@psykologi.uio.no
    First Name & Middle Initial & Last Name or Official Title & Degree
    Simon-Peter Neumer, PhD
    Phone
    +4795820508
    Email
    simon.peter.neumer@r-bup.no
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jo Magne Ingul, PhD
    Organizational Affiliation
    Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU), Trondheim, Norway
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Frode Adolfsen, PhD
    Organizational Affiliation
    Regional Centre for Child and Youth Mental Health and Child Welfare North, UiT, Tromsø, Norway
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    Angold, A., Costello, E. J., Messer, S. C., & Pickles, A. (1995). Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. International Journal of Methods in Psychiatric Research, 5(4), 237-249.
    Results Reference
    background
    Citation
    Kendall, P. C., Stark, K. D., Martinsen, K., O'Neil, K. A., & Arora, P. (2013). EMOTION:
    Results Reference
    background
    Citation
    March, J. S. (1997). MASC - Multidimensional Anxiety Scale for Children - Technical Manual. Toronto, Canada: Multi-Health Systems.
    Results Reference
    background
    Citation
    Martinsen, K. D., Kendall, P. C., Stark, K. D., Rodriguez, K. A. O. N., & Arora, P. (2014). Mestrende barn, gruppeledermanual barn. Oslo, Norway: Gyldendal Akademisk.
    Results Reference
    background
    PubMed Identifier
    27671742
    Citation
    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.
    Results Reference
    background

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    Early Intervention Coping Kids (TIM) Follow up Study

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