Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001160820
Ethics application status
Approved
Date submitted
22/07/2021
Date registered
27/08/2021
Date last updated
17/04/2024
Date data sharing statement initially provided
27/08/2021
Date results provided
17/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
MEmory Training for Recovery- Adolescent (METRA): A brief intervention targeting psychological distress among adolescents in Afghanistan
Scientific title
Randomised Clinical Trial to evaluate efficacy, feasibility and appropriateness of MEmory Training for Recovery- Adolescent (METRA) among refugee and war-affected adolescents in Afghanistan
Secondary ID [1] 303362 0
R2HC 2019 ELRHA funding (44708).
Universal Trial Number (UTN)
Trial acronym
METRA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
posttraumatic stress disorder 320625 0
depression 320626 0
Condition category
Condition code
Mental Health 318480 318480 0 0
Anxiety
Mental Health 320706 320706 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
METRA: Module 1: Memory specificity training is a manualized training delivered over five 60-minute face-to-face sessions (3-5 times per week based on local security situations) to groups of 6-8 adolescents. It is delivered by a group facilitator. Session 1 provides psycho-education about mental health and memory. Participants practice recalling memories in response to positive and neutral cues, with support from the group facilitator. Session 2 follows the same format with further practice focusing on recalling memories in response to positive and neutral cues. In Session 3, practice in response to negative cues is introduced. Session 4 involves further exercises. Session 5 includes further practice and a summary. Module 1 focuses on everyday remembering.
Module 2: Writing for Recovery is a written exposure training that involves 5 face-to-face sessions (delivered 3-5 times per week based on local security situations). It is delivered by the same group facilitator that delivered Module 1 and is delivered immediately following Module 1 (i.e., week following last session of Module 1). In the first session, the purpose of Module 2 is outlined. Then the facilitator simply reads the instructions and the participant completes the writing task; writing about their trauma including thoughts and feelings. After 30 minutes, the facilitator instructs the participants to stop writing. This writing task is repeated in the following four sessions. Each session takes 45-60 minutes.

Adherence will be monitored using session attendance checklists.
Intervention code [1] 319672 0
Treatment: Other
Comparator / control treatment
Treatment as usual (TAU): Local NGOs will provide the course of intervention that they deem appropriate (e.g., counselling, skills training). No specific instructions will be given as to what TAU should entail, except not including elements specific to METRA. TAU will be documented ensuring understanding of the duration, frequency and type of treatment administered.
Control group
Active

Outcomes
Primary outcome [1] 326438 0
Self-reported symptoms of posttraumatic stress disorder (PTSD) - assessed using the Child Revised Impact of Event Scale-13
Timepoint [1] 326438 0
The primary time point is post-Module 2. Assessments will be at baseline, post-Module 1, post-Module 2 (primary timepoint) and 3-month follow-up.
Primary outcome [2] 326439 0
Self-reported symptoms of depression - assessed using the Mood and Feeling Questionnaire - Child Self-report
Timepoint [2] 326439 0
The primary time point is post-Module 2. Assessments will be at baseline, post-Module 1, post-Module 2 (primary timepoint) and 3-month follow-up.
Secondary outcome [1] 391489 0
Symptoms of anxiety will be assessed using the The Revised Children’s Manifest Anxiety Scale
Timepoint [1] 391489 0
The primary time point is post-Module 2. Assessments will be at baseline, post-Module 1, post-Module 2 (primary timepoint) and 3-month follow-up.
Secondary outcome [2] 391491 0
Internalising/externalising symptoms will be assessed using the Strengths and Difficulties Questionnaire
Timepoint [2] 391491 0
The primary time point is post-Module 2. Assessments will be at baseline, post-Module 1, post-Module 2 (primary timepoint) and 3-month follow-up.

Eligibility
Key inclusion criteria
Afghan adolescents aged 10-19 years with elevated psychological distress. This age range aligns with our pilot work and definitions of ‘adolescent’. As in our pilot studies, elevated psychological distress is defined as >30 on the Persian Child Revised Impact of Event Scale-13 and/or >25 on the Persian Mood and Feeling Questionnaire.
Minimum age
10 Years
Maximum age
19 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria: a) high levels of suicidality, b) unmanaged psychosis/manic episodes in past month, and c) presence of head trauma/organic brain damage.

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)
We will use consecutively numbered sealed opaque envelopes to conceal the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following baseline assessment, sequential participants will be randomized to METRA or TAU.
We will use simple randomisation created by computer software. This will be developed by the team biostatistician.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/09/2021
Actual
30/11/2021
Date of last participant enrolment
Anticipated
1/01/2024
Actual
30/12/2021
Date of last data collection
Anticipated
31/10/2024
Actual
30/03/2022
Sample size
Target
100
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 23434 0
Afghanistan
State/province [1] 23434 0
Kabul

Funding & Sponsors
Funding source category [1] 307777 0
Charities/Societies/Foundations
Name [1] 307777 0
ELRHA
Country [1] 307777 0
United Kingdom
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton, Melbourne 3800 Australia
Country
Australia
Secondary sponsor category [1] 308483 0
Other Collaborative groups
Name [1] 308483 0
Behrawan Research and Psychological Services Organization
Address [1] 308483 0
Dehbori, Shahid Intersection
Kabul
Afghanistan
Country [1] 308483 0
Afghanistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307796 0
Research Committee of the Ministry of Higher Education, Afghanistan.
Ethics committee address [1] 307796 0
Ethics committee country [1] 307796 0
Afghanistan
Date submitted for ethics approval [1] 307796 0
02/08/2021
Approval date [1] 307796 0
28/11/2021
Ethics approval number [1] 307796 0

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

Contacts
Principal investigator
Name 108526 0
A/Prof Laura Jobson
Address 108526 0
Wellington Rd
Clayton
Monash University
Melbourne 3800
Victoria
Australia
Country 108526 0
Australia
Phone 108526 0
+61 3 99053945
Fax 108526 0
Email 108526 0
Laura.Jobson@monash.edu
Contact person for public queries
Name 108527 0
Daniel McAvoy
Address 108527 0
Deakin University
Holland Ave, Burwood VIC 3125
Country 108527 0
Australia
Phone 108527 0
+61 3 92517077
Fax 108527 0
Email 108527 0
daniel.mcavoy@deakin.edu.au
Contact person for scientific queries
Name 108528 0
Laura Jobson
Address 108528 0
Monash University
Wellington Rd
Clayton
Melbourne 3800
Victoria
Country 108528 0
Australia
Phone 108528 0
+61 3 99053945
Fax 108528 0
Email 108528 0
Laura.Jobson@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised participant baseline and outcome data
When will data be available (start and end dates)?
At the end of the trial - December 2024
No end date
Available to whom?
All researchers
Available for what types of analyses?
Any purpose
How or where can data be obtained?
By contacting the researchers. Email: Laura.Jobson@monash.edu


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10451Other  Laura.Jobson@monash.edu Treatment Manual



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of the Memory Training for Recovery-Adolescent Intervention vs Treatment as Usual on Psychiatric Symptoms among Adolescent Girls in Afghanistan: A Randomized Clinical Trial.2023https://dx.doi.org/10.1001/jamanetworkopen.2023.6086
Dimensions AIExamining MEmory Training for Recovery-Adolescent among Afghan adolescent boys: a pilot randomised controlled trial2023https://doi.org/10.1080/20008066.2023.2251780
N.B. These documents automatically identified may not have been verified by the study sponsor.