NCT06464627

Brief Summary

This randomized controlled trial investigated 12 weeks of physical activity or to 12 weeks in a waiting control condition in youth aged 15 to 24 years old affected by displacement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
866

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

June 13, 2024

Last Update Submit

June 13, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Patient Health Questionnaire-9

    2 weeks

  • Generalized Anxiety Disorder -7

    2 weeks

Study Arms (2)

Physical activity

EXPERIMENTAL

The project lasts 16 weeks and focuses on: improving skills and capacities of refugee and host community youth to support their psychosocial wellbeing and mental health through improved access to safe sport; developing a new/strengthened social and support network through safe sport, including those from diverse backgrounds among refugee and host community youth; working with and ensuring District Level officials appreciate and advocate for Sport for Protection activities.

Behavioral: Physical activity

Wait list

NO INTERVENTION

Wait list

Interventions

16 weeks

Physical activity

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • a) young displaced or host-community adolescents and young adults aged 15 to 24 years, and (b) at least mild symptoms of anxiety and/ or depression, defined as a Patient Health Questionnaire -9, adolescent version (PHQ-9-A) (Spitzer et al., 1999) and / or the Generalized Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006) score of 5 or higher

You may not qualify if:

  • a) young displaced or host-community adolescents and young adults younger than 15 and older than 24 years, and (b) no symptoms of anxiety and/ or depression, defined as a Patient Health Questionnaire -9, adolescent version (PHQ-9-A) (Spitzer et al., 1999) and / or the Generalized Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006) score lower than 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makerere University

Kampala, Uganda

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kathleen Latimer

    Olympic Refuge Foundation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 18, 2024

Study Start

September 1, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations