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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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
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
Mental Health 308701 308701 0 0
Mental Health 308982 308982 0 0
Other mental health disorders

Study type
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
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

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)

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 20901 0
State/province [1] 20901 0

Funding & Sponsors
Funding source category [1] 300853 0
Name [1] 300853 0
Address [1] 300853 0
1 St John's Lane, London EC1M 4AR
Country [1] 300853 0
United Kingdom
Primary sponsor type
University of New South Wales
NSW 2052
Secondary sponsor category [1] 300405 0
Name [1] 300405 0
Address [1] 300405 0
Country [1] 300405 0

Ethics approval
Ethics application status
Ethics committee name [1] 301628 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 301628 0
UNSW Sydney
NSW 2052
Ethics committee country [1] 301628 0
Date submitted for ethics approval [1] 301628 0
Approval date [1] 301628 0
Ethics approval number [1] 301628 0

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

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
Phone 87586 0
+61 293853640
Fax 87586 0
+61 293853641
Email 87586 0
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
Phone 87587 0
+61 293853640
Fax 87587 0
+61 293853641
Email 87587 0
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
Phone 87588 0
+61 293853640
Fax 87588 0
+61 293853641
Email 87588 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
How or where can data be obtained?
It will be made available via Figshare
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary