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

University of Oslo

Status: Active, not recruiting

Conditions: Depression; Anxiety Disorders

Treatments: Other: EMOTION Kids coping with anxiety and depression (Mestrende barn in Norwegian)

Study type: Interventional

Funder types: Other

Identifiers

NCT05766072

426598

Details and patient eligibility

About

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).

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 13 to 22 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who participated in the previous randomized controlled TIM study (children then aged 8- 12 years selfreporing elevated symptom levels of anxiety and/or depression)

Exclusion criteria

• all earlier participats from the TIM study may enter the follow up study
• participants who chose to not participate in the 5-year follow-up of the TIM study are excluded from the follow-up study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Intervention arm

Active Comparator group

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

Treatment:

Other: EMOTION Kids coping with anxiety and depression (Mestrende barn in Norwegian)

Control arm

No Intervention group

Description:

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