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Trial registered on ANZCTR


Registration number
ACTRN12619000341123
Ethics application status
Approved
Date submitted
3/03/2019
Date registered
5/03/2019
Date last updated
16/09/2021
Date data sharing statement initially provided
5/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing Group Psychological Help for Young Adolescent Syrian Refugees in Jordan
Scientific title
Study of Effectiveness of Group Psychological Help for Young Adolescents Impaired by Distress in Communities Exposed to Adversity
Secondary ID [1] 297587 0
Nil
Universal Trial Number (UTN)
U1111-1229-5033
Trial acronym
EASE
Linked study record
ACTRN12618001917224 represents a pilot study to the current trial

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 311845 0
Depression 311864 0
Posttraumatic stress disorder 311866 0
Condition category
Condition code
Mental Health 310442 310442 0 0
Depression
Mental Health 310443 310443 0 0
Anxiety
Mental Health 310444 310444 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this 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 12-month follow-up assessment, resulting in participation duration of 60 weeks. Therapy is provided by local health workers. Treatment adherence is checked by supervisor observation and completing intervention checklist.
Intervention code [1] 313822 0
Behaviour
Intervention code [2] 313823 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 a 12-month follow-up assessment, resulting in participation duration of 60 weeks.
Control group
Active

Outcomes
Primary outcome [1] 319311 0
Psychological distress that is measured by the Pediatric Symptom Checklist, including the internalising, externalising, and attentional subscales.
Timepoint [1] 319311 0
Pretreatment (week 1), posttreatment (week 9), & 3-months (12 months as secondary timepoint)
Secondary outcome [1] 367702 0
Depression that is measured by the Patient Health Questionnaire-Adolescent.
Timepoint [1] 367702 0
Pretreatment (week 1), posttreatment (week 9), & 3-months (12 months as secondary timepoint)
Secondary outcome [2] 367705 0
Posttraumatic stress that is measured by The Children’s Impact of Events Scale
Timepoint [2] 367705 0
Pretreatment (week 1), posttreatment (week 9), & 3-months (12 months as secondary timepoint)
Secondary outcome [3] 367707 0
Well-being as measured by Short Warwick-Edinburgh Mental Wellbeing Scale
Timepoint [3] 367707 0
Pretreatment (week 1), posttreatment (week 9), & 3-months (12 months as secondary timepoint)
Secondary outcome [4] 367709 0
Caregiver psychological distress as measured by Kessler 6
Timepoint [4] 367709 0
Pretreatment (week 1), posttreatment (week 9), & 3-months (12 months as secondary timepoint)
Secondary outcome [5] 367711 0
Caregiver parenting skills as measured by the Alabama Parenting Scale
Timepoint [5] 367711 0
Pretreatment (week 1), posttreatment (week 9), & 3-months (12 months as secondary timepoint)
Secondary outcome [6] 367715 0
School attitude as measured by the Psychological Sense of School Membership
Timepoint [6] 367715 0
Pretreatment (week 1), posttreatment (week 9), & 3-months (12 months as secondary timepoint)
Secondary outcome [7] 367716 0
Caregiver report of child's psychological distress that are measured by the Pediatric Symptom Checklist - Caregiver Version
Timepoint [7] 367716 0
Pretreatment (week 1), posttreatment (week 9), & 3-months (12 months as secondary timepoint)
Secondary outcome [8] 367717 0
Functioning as measured by the Impairment of Daily Functioning Questionnaire
Timepoint [8] 367717 0
Pretreatment (week 1), posttreatment (week 9), & 3-months (12 months as secondary timepoint)

Eligibility
Key inclusion criteria

Inclusion criteria are (a) Syrian refugees, (b) Pediatric Symptom Checklist 17 score of 15, (c) can understand instructions, (d) has a caregiver who can provide informed consent.
Minimum age
10 Years
Maximum age
14 Years
Sex
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) to EASE or usual care on a 1 : 1.6 ratio.
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 trial and is 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
Completed
Date of first participant enrolment
Anticipated
26/08/2019
Actual
10/06/2019
Date of last participant enrolment
Anticipated
27/01/2020
Actual
6/02/2020
Date of last data collection
Anticipated
29/03/2021
Actual
15/04/2021
Sample size
Target
470
Accrual to date
Final
471
Recruitment outside Australia
Country [1] 21322 0
Jordan
State/province [1] 21322 0
Amman

Funding & Sponsors
Funding source category [1] 302138 0
Charities/Societies/Foundations
Name [1] 302138 0
Elhra
Country [1] 302138 0
United Kingdom
Primary sponsor type
University
Name
University of New South Wales
Address
Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 301973 0
None
Name [1] 301973 0
NA
Address [1] 301973 0
NA
Country [1] 301973 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302817 0
Al-Bashir Hospital Ethics Committee
Ethics committee address [1] 302817 0
Ethics committee country [1] 302817 0
Jordan
Date submitted for ethics approval [1] 302817 0
04/12/2018
Approval date [1] 302817 0
05/12/2018
Ethics approval number [1] 302817 0
10276

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

Contacts
Principal investigator
Name 91494 0
Prof Richard Bryant
Address 91494 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 91494 0
Australia
Phone 91494 0
+61293853640
Fax 91494 0
+61293853641
Email 91494 0
[email protected]
Contact person for public queries
Name 91495 0
Richard Bryant
Address 91495 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 91495 0
Australia
Phone 91495 0
+61293853640
Fax 91495 0
+61293853641
Email 91495 0
[email protected]
Contact person for scientific queries
Name 91496 0
Richard Bryant
Address 91496 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 91496 0
Australia
Phone 91496 0
+61293853640
Fax 91496 0
+61293853641
Email 91496 0
[email protected]

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 follow-up data.
When will data be available (start and end dates)?
Following publication of the study outcomes, and sharing of data with our consortium members. Data will be available after 2022, and there will be no end date for access.
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-analysis 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 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
EmbaseEffectiveness of a brief group behavioural intervention on psychological distress in young adolescent Syrian refugees: A randomised controlled trial.2022https://dx.doi.org/10.1371/journal.pmed.1004046
N.B. These documents automatically identified may not have been verified by the study sponsor.