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Trial registered on ANZCTR


Registration number
ACTRN12618001917224
Ethics application status
Approved
Date submitted
26/10/2018
Date registered
26/11/2018
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study of Testing Group Psychological Help for Young Adolescent Syrian Refugees in Jordan
Scientific title
Pilot Study of Effectiveness of Group Psychological Help for Young Adolescents Impaired by Distress in Communities Exposed to Adversity
Secondary ID [1] 296259 0
Nil
Universal Trial Number (UTN)
Trial acronym
EASE Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 309923 0
Depression 309924 0
Posttraumatic stress disorder 309927 0
Condition category
Condition code
Mental Health 308700 308700 0 0
Depression
Mental Health 308701 308701 0 0
Anxiety
Mental Health 308982 308982 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this pilot trial. Arm 1: Early Adolescent Skills for Emotions. Arm 2: Enhanced Treatment as Usual. Therapy is group-administered once-weekly for 90 minutes over 7 weeks for young adolescents. In addition, there are 3 fortnightly 90-minute group sessions that are administered separately for caregivers and occur during the course of the adolescents' program. Early Adolescent Skills for Emotions includes skills in psychoeducation, problem solving, arousal management, behavioural activation, and relapse prevention. The caregiver sessions involve psychoeducation, active listening, quality time, praise, caregiver self-care and relapse prevention. The duration of the study for any participant will conclude after a post-intervention assessment, resulting in participation duration of 9 weeks. Therapy is provided by local health workers.
Intervention code [1] 312590 0
Behaviour
Intervention code [2] 312591 0
Treatment: Other
Comparator / control treatment
Enhanced Treatment as Usual comprises normal treatment provided by local counselors. Enhanced Treatment as Usual involves referral to local psychosocial services, as well as provision of basic education about common psychological problems. The duration of the study for any participant will conclude after an assessment 9 weeks after the baseline assessment, resulting in participation duration of 9 weeks..
Control group
Active

Outcomes
Primary outcome [1] 307677 0
Psychological distress that are measured by the Pediatric Symptom Checklist
Timepoint [1] 307677 0
Pretreatment (week 1), and posttreatment (week 9)
Secondary outcome [1] 352555 0
Depression that is measured by the Patient Health Questionnaire-Adolescent.
Timepoint [1] 352555 0
Pretreatment (week 1), and posttreatment (week 9)
Secondary outcome [2] 352556 0
Posttraumatic stress that is measured by The Children’s Impact of Events Scale
Timepoint [2] 352556 0
Pretreatment (week 1), and posttreatment (week 9)
Secondary outcome [3] 352579 0
Well-being as measured by Short Warwick-Edinburgh Mental Wellbeing Scale
Timepoint [3] 352579 0
Pretreatment (week 1), and posttreatment (week 9)
Secondary outcome [4] 352580 0
Caregiver psychological distress as measured by Kessler 6
Timepoint [4] 352580 0
Pretreatment (week 1), and posttreatment (week 9)
Secondary outcome [5] 352581 0
•Caregiver parenting skills as measured by the Alabama Parenting Scale
Timepoint [5] 352581 0
Pretreatment (week 1), and posttreatment (week 9)

Eligibility
Key inclusion criteria
Inclusion criteria are (a) Syrian refugees, (b) Child Psychosocial Distress Screener score of >5, (c) can understand instructions, (d) has a caregiver who can provide informed consent.
Minimum age
10 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include (a) unaccompanied minors, (b) children or caregivers that are at risk for harming self and/or others, (c) children or caregivers that unable to understand explanations instructions, (d) imminent risk of child abuse and requires urgent child protection, or (e) married

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be young adolescent Syrian refugees indicating moderate distress. Participants wishing to participate will be randomly allocated according to a random numbers system administered by an individual who independent of the study and who works at a site that is independent from the trial centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This study represents a pilot trial and is not intended to be powered to detect significant differences between treatment arms. Analyses of the relative efficacy of the EASE program will be evaluated using linear mixed models analysis. The Level 1 model will represent within-patient change over time, and the Level 2 model will predict variation in within-patient
change over time and encompass between-patient variables (treatment condition). Primary outcome will comprise the PSC.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20901 0
Jordan
State/province [1] 20901 0
Amman

Funding & Sponsors
Funding source category [1] 300853 0
Charities/Societies/Foundations
Name [1] 300853 0
Elhra
Address [1] 300853 0
1 St John's Lane, London EC1M 4AR
Country [1] 300853 0
United Kingdom
Primary sponsor type
University
Name
University of New South Wales
Address
Sydney
NSW 2052
Country
Australia
Secondary sponsor category [1] 300405 0
None
Name [1] 300405 0
Address [1] 300405 0
Country [1] 300405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301628 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 301628 0
UNSW Sydney
Sydney
NSW 2052
Ethics committee country [1] 301628 0
Australia
Date submitted for ethics approval [1] 301628 0
05/06/2017
Approval date [1] 301628 0
27/07/2017
Ethics approval number [1] 301628 0
HC17520

Summary
Brief summary
The rationale of the study is to evaluate the efficacy of a low intensity intervention to reduce mental health problems in young adolescent refugees. This study compares the relative efficacy of (a) Early Adolescent Skills for Emotions, and (b) Enhanced Treatment as Usual. It is hypothesised that Early Adolescent Skills for Emotions will lead to greater symptom reduction than Enhanced Treatment as Usual.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87586 0
Prof Richard Bryant
Address 87586 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 87586 0
Australia
Phone 87586 0
+61 293853640
Fax 87586 0
+61 293853641
Email 87586 0
r.bryant@unsw.edu.au
Contact person for public queries
Name 87587 0
Prof Richard Bryant
Address 87587 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 87587 0
Australia
Phone 87587 0
+61 293853640
Fax 87587 0
+61 293853641
Email 87587 0
r.bryant@unsw.edu.au
Contact person for scientific queries
Name 87588 0
Prof Richard Bryant
Address 87588 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 87588 0
Australia
Phone 87588 0
+61 293853640
Fax 87588 0
+61 293853641
Email 87588 0
r.bryant@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Baseline and posttreatment data.
When will data be available (start and end dates)?
Following publication of the study outcomes, and sharing of data with our consortium members. Date unknown.
Available to whom?
Initially to STRENGTHS collaborators, and then it will be available for open access.
Available for what types of analyses?
Individual person data meta-anlaysis of treatment outcomes
By what mechanism will data be made available?
It will be made available via Figshare
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable