ANZCTR - Registration

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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]

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

depression

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

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]

Self-reported symptoms of posttraumatic stress disorder (PTSD) - assessed using the Child Revised Impact of Event Scale-13

Timepoint [1]

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]

Self-reported symptoms of depression - assessed using the Mood and Feeling Questionnaire - Child Self-report

Timepoint [2]

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]

Quality of Life will be assessed using the Youth Quality of Life Short Form

Timepoint [1]

Assessments will be at baseline, post-Module 1, post-Module 2 and 3-month follow-up.

Secondary outcome [2]

Symptoms of anxiety will be assessed using the The Revised Children’s Manifest Anxiety Scale

Timepoint [2]

Assessments will be at baseline, post-Module 1, post-Module 2 and 3-month follow-up

Secondary outcome [3]

Psychiatric Difficulties will be assessed using the Strengths and Difficulties Questionnaire

Timepoint [3]

Assessments will be at baseline, post-Module 1, post-Module 2 and 3-month follow-up.

Secondary outcome [4]

Rumination will be assessed using the Childrens Responses Styles Questionnaire

Timepoint [4]

Assessments will be at baseline, post-Module 1, post-Module 2 and 3-month follow-up.

Secondary outcome [5]

Cognitive Avoidance will be assessed using the Cognitive Avoidance Questionnaire

Timepoint [5]

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?

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]

Iraq

State/province [1]

Kirkuk

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

ELRHA

Address [1]

Elrha
8 Cathedral Rd
Cardiff
CF11 9LJ
United Kingdom

Country [1]

United Kingdom

Primary sponsor type

University

Name

Monash University

Address

Wellington Rd
Clayton, Melbourne
Victoria, 3800 Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

none

Country [1]

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

National Institute for Human Rights

Address [1]

Iraq, Kirkuk, Baghdad Road, Al-amal Compound, Building No. 236

Country [1]

Iraq

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Monash University
Wellington Road
Clayton
Melbourne 3800
Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/09/2022

Ethics approval number [1]

Project ID: 35071

Summary

Brief summary

Adolescents in low- and middle-income countries (LMICs), such as Iraq, experience concerning levels of psychological distress, including posttraumatic stress disorder (PTSD), depression, and anxiety. These symptoms severely affect an adolescent’s life, including long-lasting cognitive, emotional, social and academic/vocational problems. Addressing psychological concerns in the critical developmental period of adolescence is imperative. However, very few adolescents in Iraq receive evidence-based interventions, due to high costs, limited mental health services and a shortage of skilled professionals. The needs of adolescents in LMICs (such as adolescents in Iraq) have not received sufficient attention in psychology/psychiatry research. In order to meet these identified needs, our MEmory Training for Recovery-Adolescent (METRA) research emerged; METRA is a low-intensity, accessible and scalable evidence-based intervention aimed to reduce psychological distress.

Our aim is to investigate the efficacy of METRA in improving psychological symptoms (posttraumatic stress disorder, depression) in adolescents living in Iraq.

We predict that METRA will improve symptoms of psychological distress (PTSD and depression) in adolescents living in Iraq and will be an acceptable and feasible intervention.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Laura Jobson

Address

Wellington Rd
Clayton
Monash University
Melbourne 3800
Victoria
Australia

Country

Australia

Phone

+61 399053945

Fax

Laura.Jobson@monash.edu

Contact person for public queries

Name

Daniel McAvoy

Address

Deakin University
Holland Ave, Burwood VIC 3125

Country

Australia

Phone

+61 3 92517077

Fax

daniel.mcavoy@deakin.edu.au

Contact person for scientific queries

Name

Laura Jobson

Address

Wellington Rd
Clayton
Monash University
Melbourne 3800
Victoria
Australia

Country

Australia

Phone

+61 399053945

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
17472	Study protocol				Open Science Framework (OSF)	384897-(Uploaded-18-11-2022-15-40-06)-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.

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