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Trial registered on ANZCTR
Registration number
ACTRN12619000285156
Ethics application status
Approved
Date submitted
19/02/2019
Date registered
25/02/2019
Date last updated
25/02/2019
Date data sharing statement initially provided
25/02/2019
Date results information initially provided
25/02/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Psychosocial Support intervention for Improving Oral Health and the related quality of life of War Affected Children: A quasi randomized controlled trial
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Scientific title
A Short-term Approach for promoting Oral Health of Internally Displaced Children with post-traumatic stress disorder (PTSD)
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Secondary ID [1]
297440
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
post-traumatic stress disorder
311624
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Oral health
311626
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Condition category
Condition code
Mental Health
310252
310252
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0
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Other mental health disorders
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Public Health
310253
310253
0
0
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Health promotion/education
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Oral and Gastrointestinal
310254
310254
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In the current study a short-term (6-week) integrative approach was designed. The aim was to promote oral health status in addition to mental health of war affected children. Targeted population was selected from 4 temporary accommodation centers (TACs) in four different cities in Damascus, Syria. Two TACs were randomly selected (using a simple coin toss technique) to obtain the intervention. The two other TACs had no intervention and served as controls. Therefore, children weren't randomly selected and the study followed a quasi-randomized trial design. Only children suffering from post-traumatic stress disorder and aged between 9-14 years were invited to participate. Post-traumatic stress disorder was diagnosed prior to the intervention using child post-traumatic stress disorder reaction index. Children were randomly assigned into two groups (intervention group and control group). Only children in the intervention group were enrolled in the program. The program included psychosocial support (PSS) integrated with an oral health education (OHE). The 12-session approach was carried out for 6 weeks. Children had attended 2 sessions weekly in terms of groups. The intervention group included 6 sub-groups, each sub-group had 18-20 children. For six weeks, the exact same session was conducted for two groups in the first three days of the week. In the following three days a new session was carried out including two groups daily. Every session took about 60-90 minutes. The program included 8 sessions of PSS and the last 4 sessions were integrated with OHE. A pediatric dentist (7 years of experience) held the oral health educational program, while two social workers (well-trained by a psychologist) conducted PSS part of the program. The same psychologist supervised the whole sessions and was always available in case any children had serious symptoms and needed urgent referral. Sessions had various integrated activities such as playing, drawing, and acting as well as relaxation methods. Educational materials about oral health included presentations, videos, illustration tools and storytelling. PSS focused in trauma healing, open discussions about social problems, friendly behavior and positive vision about the future. The educational program focused in oral and dental diseases and their consequences, prevention methods, treatment procedures and tools, stages of teething and dental appearance. Children were also informed about the importance of oral health to the whole body and how periodic checkups are necessary for their oral and dental health.
Oral health evaluation included Plaque index (PI) and gingival index (GI). Oral health related Quality of life was evaluated using child perception questionnaire from 11-14 years (CPQ11-14). The investigator (pediatric dentist) conducted the clinical examination and supervised the questionnaire completion. The same dentist also monitored children's adherence to the intervention using session attendance checklist. Study variables were evaluated at baseline and after 6 weeks (end of the program) for both groups.
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Intervention code [1]
313700
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Prevention
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Intervention code [2]
313701
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Rehabilitation
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Comparator / control treatment
Children in the control group served as a comparison group to screen the spontaneous improvement (if any) of study variables after 6 weeks without any intervention.
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Control group
Active
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Outcomes
Primary outcome [1]
319138
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Change in plaque accumulation using Plaque Index by Silness and Löe.
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Assessment method [1]
319138
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Timepoint [1]
319138
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Dental Plaque was assessed at baseline and within one week of the end of the program
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Primary outcome [2]
319139
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Change in gingival health using Gingival Index by Löe and Silness
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Assessment method [2]
319139
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Timepoint [2]
319139
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Gingival health was assessed at baseline and within one week of the end of the program
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Primary outcome [3]
319152
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change in mental health using post-traumatic stress disorder reaction index by Pynoos.
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Assessment method [3]
319152
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Timepoint [3]
319152
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post-traumatic stress disorder was assessed at baseline and within one week of the end of the program
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Secondary outcome [1]
367072
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change of oral health related quality of life was assessed using child perception questionnaire 11-14 years by Jokovic et al.
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Assessment method [1]
367072
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Timepoint [1]
367072
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Oral health related quality of life was assessed at baseline and within one week of the end of the program
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Eligibility
Key inclusion criteria
Children aged between 9-14 years.
Children diagnosed with post-traumatic stress disorder.
Children who are able to practice oral hygiene without any help from parents.
Children who approved with their parents/guardians to participate in the study.
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Minimum age
9
Years
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Maximum age
14
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Children who did not meet inclusion criteria.
Children who are taking antibiotics a week before clinical examination.
Children under dental treatment.
Children under another oral health educational program and psychosocial support.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The sample size calculation was based on previous study that evaluated the effectiveness of short-term group intervention for children affected by war and suffering from PTSD. A total of 40 patients in each group were necessary to reach 80% of statistical power for this interventional study. Therefore, a total sample size should include eighty subjects (N=80). To allow adjustment of other factors such as withdrawals and missing data, additional subjects (20 subjects) were added to each group. Therefore, the study included an intervention group (n=60) and a matching controls (n=60).
Data were analyzed by means of SPSS program (version 20). Kruskall-Wallis test was used to check the normality distribution of the data. To assess the mean differences and changes over time from baseline to the end of the program Wilcoxon signed rank test was used since data wasn't normally distributed. To determine the approach effectiveness differences between the intervention and the control group pre and post program, independent sample t-test was used. The P value for all tests was set at 0.05.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
5/05/2017
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Date of last participant enrolment
Anticipated
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Actual
20/05/2017
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Date of last data collection
Anticipated
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Actual
8/07/2017
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Sample size
Target
120
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Accrual to date
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Final
118
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Recruitment outside Australia
Country [1]
21288
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Syrian Arab Republic
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State/province [1]
21288
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Damascus city
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Funding & Sponsors
Funding source category [1]
302012
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University
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Name [1]
302012
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Damascus University
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Address [1]
302012
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Baramkeh Street
Damascus University Central administration, Damascus University
Damascus
Syria
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Country [1]
302012
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Syrian Arab Republic
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Primary sponsor type
University
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Name
Damascus University
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Address
Baramkeh Street
Damascus University Central administration, Damascus University
Damascus
Syria
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Country
Syrian Arab Republic
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Secondary sponsor category [1]
301795
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University
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Name [1]
301795
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Faculty of Dentistry, Damascus University
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Address [1]
301795
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Mazzeh Highway Street
Faculty of Dentistry, Damascus University
Damascus
Syria
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Country [1]
301795
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Syrian Arab Republic
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302688
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Ethical Committee of the Faculty of Dentistry in Damascus University, Syria.
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Ethics committee address [1]
302688
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Mazzeh Highway Street
Faculty of Dentistry, Damascus University
Damascus
Syria
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Ethics committee country [1]
302688
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Syrian Arab Republic
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Date submitted for ethics approval [1]
302688
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01/05/2016
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Approval date [1]
302688
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16/05/2016
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Ethics approval number [1]
302688
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2039
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Summary
Brief summary
The aim was to evaluate the effectiveness of short-term integrative psychosocial-oral support approach in improving oral health and oral health-related quality of life for displaced children suffering from post-traumatic stress disorder (PTSD). Children were assigned into two groups (intervention group and control group). Only children in the intervention group were enrolled in a 6-week program designed especially for this study. The program included 8 sessions of psychosocial support (PSS) integrated with 4 sessions of oral health education (OHE). It was hypothesized that the designed approach could improve both oral and mental health of displaced children.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
91062
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Dr Sulaf Hamid
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Address
91062
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Mazzeh Highway Street
Faculty of Dentistry, Damascus University
Damascus
Syria
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Country
91062
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Syrian Arab Republic
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Phone
91062
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+963 966802268
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Fax
91062
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Email
91062
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[email protected]
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Contact person for public queries
Name
91063
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Dr Sulaf Hamid
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Address
91063
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Mazzeh Highway Street
Faculty of Dentistry, Damascus University
Damascus
Syria
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Country
91063
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Syrian Arab Republic
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Phone
91063
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+963 966802268
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Fax
91063
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Email
91063
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[email protected]
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Contact person for scientific queries
Name
91064
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Dr Sulaf Hamid
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Address
91064
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Mazzeh Highway Street
Faculty of Dentistry, Damascus University
Damascus
Syria
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Country
91064
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Syrian Arab Republic
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Phone
91064
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+963 966802268
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Fax
91064
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Email
91064
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
A short-term approach for promoting oral health of internally displaced children with PTSD: the key is improving mental health-results from a quasi-randomized trial.
2021
https://dx.doi.org/10.1186/s12903-020-01385-z
N.B. These documents automatically identified may not have been verified by the study sponsor.
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