NCT05233345

Brief Summary

Cognitive and learning difficulties created by traumatic events related to difficulties and trauma experienced during the Syrian civil war and resettlement period in Turkey might have been complicated by the limitations of the COVID19 pandemic. Thus, it is of utmost importance to find out and implement effective and feasible ways of intervention to ameliorate adverse effects of the refugee experience and COVID19 pandemic on cognitive functions, well-being, quality of life, and occupational balance in these children. Thus, this research was designed a randomized controlled trial in which examining the effects of a customized online occupational training program encompassing various activities on the aforementioned aspects of refugee children resettled in Turkey. The present study was designed as a randomized controlled study, including pre-post testing. Occupational balance, well-being and health-related quality of life were evaluated via the Occupational Balance Questionnaire (OBQ11), Well Star Scale (WSS) and the Pediatric Quality of Life Inventory (PedsQL). The intervention group attended online occupational therapy classes. Online classes were carried out as 5 sessions per week, each session lasting 1 hour, for 3 weeks. Questionnaires performed at the outset of the study and following the training program. Overall, 52 refugee children were randomized into intervention and control groups, each including 26 children. The mean WSS, PedsQL and OBQ11 scores significantly improved in the intervention group than in the control group. This was the first study investigating the effects of a customized online training course on well-being, occupational balance and quality of life in Syrian refugee children, also affected unfavorably by COVID19 lockdown. The results showed significant improvements in all study scales that we used to quantify the alterations in the aforementioned traits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2020

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
Last Updated

February 10, 2022

Status Verified

February 1, 2022

Enrollment Period

18 days

First QC Date

January 30, 2022

Last Update Submit

February 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Occupational Balance Questionnaire (revised version, OBQ11)

    The total score is between 0-33. Minimum score is 0. Maximum score is 33. This questionnaire is used to assess the activity-role balance according to the level of contention and to define the variety of the activities and occupational balance based on the results of obtained data.

    3 weeks

Secondary Outcomes (2)

  • The Well-Star Scale

    3 weeks

  • Pediatric Quality of Life Inventory (PedsQL)

    3 weeks

Study Arms (2)

Experimental group: web based occupational therapy program

EXPERIMENTAL

Web-based occupational therapy classes were carried out as 5 sessions per week, each session lasting 1 hour, for 3 weeks. In total, 15 sessions were performed during the study period. Group activities were performed through the Zoom application by means of a video camera. Included painting and cake making together, sports activities to be performed simultaneously with the movements shown by the researcher, memory games, and games that can be played with the group, such as the categories game. Sports activities were performed in the last 15 minutes of group activities, 5 days a week, in order to increase the physical activity level of children whose physical activities decreased during the lockdown period at home. Also, all study participants continued taking classes from the EBA program as part of their routine education plan while taking occupational therapy program. EBA program is online classes given by government on local television.

Behavioral: Occupational Therapy

Control Group

NO INTERVENTION

There are no interventions except EBA which all study participants are already taking classes from as part of their routine education plan. EBA program is online classes given by government on local television. This program is out of our study.

Interventions

online occupational therapy sessions are based on the activity training

Experimental group: web based occupational therapy program

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • aged between 13-15 years
  • having experienced war at home country
  • being a current resident in Fatih province of Istanbul
  • being able to read and write (literate) in Turkish
  • living at home during the lockdown
  • attending online classes through the Ministry of National Education Online Education Platform (EBA)
  • willingness to participate in the study by both the child and their families.

You may not qualify if:

  • the presence of a known neurologic or developmental disorder or learning difficulty
  • already participating in an additional education or activity program apart from the EBA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sümeyye Belhan Çelik

Ankara, 06180, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Occupational Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Sümeyye Belhan Çelik, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single (Investigator)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This prospective studies that measure the effectiveness of occupational therapy intervention. Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment. Participants are recruited and randomly assigned to either the intervention or the comparator group. It is important to ensure that at the time of recruitment there is no knowledge of which group the participant will be allocated to; this is known as concealment. It is examined whether there is any difference in the results of the study intervention and also the intervention and control group are compared.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2022

First Posted

February 10, 2022

Study Start

December 13, 2020

Primary Completion

December 31, 2020

Study Completion

March 30, 2021

Last Updated

February 10, 2022

Record last verified: 2022-02

Locations