Early Intervention Coping Kids (TIM) Follow up Study

Not Applicable

Active, not recruiting

• Conditions: Anxiety Disorders; Depression

• Registration Number: NCT05766072
• Lead Sponsor: University of Oslo

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).

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Study Start: 2023-03-13
• Study First Posted: 2023-03-13
• Primary Completion: 2024-02-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-10
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Multidimensional anxiety scale for children	5- year follow up	This 39-item, child self-report, assesses anxiety in youth ages 8 - 19, 0 - 117, higher score, higher anxiety
The Mood and Feelings Questionnaire Short version	5-year follow up	SMFQ comprised of 13 questions assessing cognitive, affective and behavioral-related depressive symptoms in youth ages 8 - 18 during the last two weeks, 0 - 26, higher score indicating higher levels of depression
The ADIS (Anxiety Disorders Interview Schedule)	5-year follow up	Relevant sections of this semi-structured interview (anxiety and depression), categorical outcome, have diagnosis/does not have diagnosis

Trial Locations

Locations (1)

University of Oslo; 🇳🇴 Oslo, Norge, Norway