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Trial registered on ANZCTR


Registration number
ACTRN12622001413718
Ethics application status
Approved
Date submitted
29/10/2022
Date registered
4/11/2022
Date last updated
17/04/2024
Date data sharing statement initially provided
4/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
MEmory Training for Recovery- Adolescent (METRA): A brief intervention targeting psychological distress in Iraqi adolescents
Scientific title
Randomised Clinical Trial to evaluate efficacy, feasibility and appropriateness of MEmory Training for Recovery- Adolescent (METRA) among war-affected adolescents in Iraq
Secondary ID [1] 308283 0
R2HC 2019 ELRHA funding (44708).
Universal Trial Number (UTN)
Trial acronym
METRA Trial
Linked study record
The current study is a follow-up study to registration record ACTRN12621001160820.

Health condition
Health condition(s) or problem(s) studied:
posttraumatic stress disorder 328065 0
depression 328066 0
Condition category
Condition code
Mental Health 325125 325125 0 0
Anxiety
Mental Health 325126 325126 0 0
Depression

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] 324734 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] 332942 0
Self-reported symptoms of posttraumatic stress disorder (PTSD) - assessed using the Child Revised Impact of Event Scale-13
Timepoint [1] 332942 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] 332943 0
Self-reported symptoms of depression - assessed using the Mood and Feeling Questionnaire - Child Self-report
Timepoint [2] 332943 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] 415251 0
Quality of Life will be assessed using the Youth Quality of Life Short Form
Timepoint [1] 415251 0
Assessments will be at baseline, post-Module 1, post-Module 2 and 3-month follow-up.
Secondary outcome [2] 415252 0
Symptoms of anxiety will be assessed using the The Revised Children’s Manifest Anxiety Scale
Timepoint [2] 415252 0
Assessments will be at baseline, post-Module 1, post-Module 2 and 3-month follow-up
Secondary outcome [3] 415253 0
Psychiatric Difficulties will be assessed using the Strengths and Difficulties Questionnaire
Timepoint [3] 415253 0
Assessments will be at baseline, post-Module 1, post-Module 2 and 3-month follow-up.
Secondary outcome [4] 415254 0
Rumination will be assessed using the Childrens Responses Styles Questionnaire
Timepoint [4] 415254 0
Assessments will be at baseline, post-Module 1, post-Module 2 and 3-month follow-up.
Secondary outcome [5] 415255 0
Cognitive Avoidance will be assessed using the Cognitive Avoidance Questionnaire
Timepoint [5] 415255 0
Assessments will be at baseline, post-Module 1, post-Module 2 and 3-month follow-up.

Eligibility
Key inclusion criteria
Iraqi 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 greater or equal to 25 on the Child Revised Impact of Event Scale-13 and/or >12 on the Mood and Feeling Questionnaire.
Minimum age
10 Years
Maximum age
19 Years
Sex
Both males and 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
16/05/2023
Actual
1/07/2023
Date of last participant enrolment
Anticipated
31/08/2023
Actual
1/11/2023
Date of last data collection
Anticipated
29/12/2023
Actual
30/01/2024
Sample size
Target
100
Accrual to date
Final
132
Recruitment outside Australia
Country [1] 25089 0
Iraq
State/province [1] 25089 0
Kirkuk

Funding & Sponsors
Funding source category [1] 312532 0
Charities/Societies/Foundations
Name [1] 312532 0
ELRHA
Country [1] 312532 0
United Kingdom
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd
Clayton, Melbourne
Victoria, 3800 Australia
Country
Australia
Secondary sponsor category [1] 314133 0
None
Name [1] 314133 0
none
Address [1] 314133 0
none
Country [1] 314133 0
Other collaborator category [1] 282468 0
Charities/Societies/Foundations
Name [1] 282468 0
National Institute for Human Rights
Address [1] 282468 0
Iraq, Kirkuk, Baghdad Road, Al-amal Compound, Building No. 236
Country [1] 282468 0
Iraq

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311865 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 311865 0
Ethics committee country [1] 311865 0
Australia
Date submitted for ethics approval [1] 311865 0
Approval date [1] 311865 0
13/09/2022
Ethics approval number [1] 311865 0
Project ID: 35071

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

Contacts
Principal investigator
Name 122646 0
A/Prof Laura Jobson
Address 122646 0
Wellington Rd Clayton Monash University Melbourne 3800 Victoria Australia
Country 122646 0
Australia
Phone 122646 0
+61 399053945
Fax 122646 0
Email 122646 0
[email protected]
Contact person for public queries
Name 122647 0
Daniel McAvoy
Address 122647 0
Deakin University Holland Ave, Burwood VIC 3125
Country 122647 0
Australia
Phone 122647 0
+61 3 92517077
Fax 122647 0
Email 122647 0
[email protected]
Contact person for scientific queries
Name 122648 0
Laura Jobson
Address 122648 0
Wellington Rd Clayton Monash University Melbourne 3800 Victoria Australia
Country 122648 0
Australia
Phone 122648 0
+61 399053945
Fax 122648 0
Email 122648 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• All researchers

Conditions for requesting access:
• -

What individual participant data might be shared?
• Anonymised participant baseline and outcome data

What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
At the end of the trial

To:
December 2024
No end date

Where can requests to access individual participant data be made, or data be obtained directly?
• By contacting the researchers. Email: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17472Study protocol    Open Science Framework (OSF) Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.