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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
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
Scientific title
A Short-term Approach for promoting Oral Health of Internally Displaced Children with post-traumatic stress disorder (PTSD)
Secondary ID [1] 297440 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-traumatic stress disorder 311624 0
Oral health 311626 0
Condition category
Condition code
Mental Health 310252 310252 0 0
Other mental health disorders
Public Health 310253 310253 0 0
Health promotion/education
Oral and Gastrointestinal 310254 310254 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 313700 0
Prevention
Intervention code [2] 313701 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 319138 0
Change in plaque accumulation using Plaque Index by Silness and Löe.
Timepoint [1] 319138 0
Dental Plaque was assessed at baseline and within one week of the end of the program
Primary outcome [2] 319139 0
Change in gingival health using Gingival Index by Löe and Silness
Timepoint [2] 319139 0
Gingival health was assessed at baseline and within one week of the end of the program
Primary outcome [3] 319152 0
change in mental health using post-traumatic stress disorder reaction index by Pynoos.
Timepoint [3] 319152 0
post-traumatic stress disorder was assessed at baseline and within one week of the end of the program
Secondary outcome [1] 367072 0
change of oral health related quality of life was assessed using child perception questionnaire 11-14 years by Jokovic et al.
Timepoint [1] 367072 0
Oral health related quality of life was assessed at baseline and within one week of the end of the program

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.
Minimum age
9 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/05/2017
Date of last participant enrolment
Anticipated
Actual
20/05/2017
Date of last data collection
Anticipated
Actual
8/07/2017
Sample size
Target
120
Accrual to date
Final
118
Recruitment outside Australia
Country [1] 21288 0
Syrian Arab Republic
State/province [1] 21288 0
Damascus city

Funding & Sponsors
Funding source category [1] 302012 0
University
Name [1] 302012 0
Damascus University
Country [1] 302012 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Baramkeh Street
Damascus University Central administration, Damascus University
Damascus
Syria
Country
Syrian Arab Republic
Secondary sponsor category [1] 301795 0
University
Name [1] 301795 0
Faculty of Dentistry, Damascus University
Address [1] 301795 0
Mazzeh Highway Street
Faculty of Dentistry, Damascus University
Damascus
Syria
Country [1] 301795 0
Syrian Arab Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302688 0
Ethical Committee of the Faculty of Dentistry in Damascus University, Syria.
Ethics committee address [1] 302688 0
Ethics committee country [1] 302688 0
Syrian Arab Republic
Date submitted for ethics approval [1] 302688 0
01/05/2016
Approval date [1] 302688 0
16/05/2016
Ethics approval number [1] 302688 0
2039

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91062 0
Dr Sulaf Hamid
Address 91062 0
Mazzeh Highway Street
Faculty of Dentistry, Damascus University
Damascus
Syria
Country 91062 0
Syrian Arab Republic
Phone 91062 0
+963 966802268
Fax 91062 0
Email 91062 0
sulaf-rose@hotmail.com
Contact person for public queries
Name 91063 0
Sulaf Hamid
Address 91063 0
Mazzeh Highway Street
Faculty of Dentistry, Damascus University
Damascus
Syria
Country 91063 0
Syrian Arab Republic
Phone 91063 0
+963 966802268
Fax 91063 0
Email 91063 0
sulaf-rose@hotmail.com
Contact person for scientific queries
Name 91064 0
Sulaf Hamid
Address 91064 0
Mazzeh Highway Street
Faculty of Dentistry, Damascus University
Damascus
Syria
Country 91064 0
Syrian Arab Republic
Phone 91064 0
+963 966802268
Fax 91064 0
Email 91064 0
sulaf-rose@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseA 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.2021https://dx.doi.org/10.1186/s12903-020-01385-z
N.B. These documents automatically identified may not have been verified by the study sponsor.