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Trial registered on ANZCTR


Registration number
ACTRN12624001453572p
Ethics application status
Not yet submitted
Date submitted
28/11/2024
Date registered
16/12/2024
Date last updated
16/12/2024
Date data sharing statement initially provided
16/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
MEmory Training for Recovery- Adolescent Plus (METRA+): A brief intervention targeting psychosocial distress among Afghan adolescents living in Pakistan
Scientific title
Pilot study evaluating the efficacy, feasibility and appropriateness of MEmory Training for Recovery- Adolescent Plus (METRA+) among Afghan adolescents with a refugee background living in Pakistan
Secondary ID [1] 313491 0
none
Universal Trial Number (UTN)
Trial acronym
METRA+
Linked study record
ACTRN12622001413718.
This is a follow-up study. The aim of this study is to further METRA investigated in the study (ACTRN12622001413718) by adding sessions targeting social functioning - METRA+

Health condition
Health condition(s) or problem(s) studied:
posttraumatic stress disorder 335900 0
depression 335901 0
Condition category
Condition code
Mental Health 332494 332494 0 0
Anxiety
Mental Health 332495 332495 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.
Module 3: Social skills training. Will include three social skills training sessions. This is based on "Nonviolent Communication" training to address trauma. This program has been previously implemented this program for students and faculty at Kabul University. We would use this three-session protocol for Afghan adolescents in Pakistan. The goal of these sessions is to foster appropriate communication through compassion and empathy for oneself and others. Module 3 will focus on four components – observations, feelings, needs, and requests – though empathic connection. With a focus on peer and family/parent relationships

METRA+ will be delivered consecutively - the three modules will be delivered over a 2-3 week period (with no breaks between the modules, with the exception of weekends)
METRA+ will be delivered daily, with each session being 60 minutes, over a 2-3 week period. Module 1 is five sessions delivered in Week 1. Module 2 is five sessions and will be delivered in Week 2, Module 3 will be delivered for the beginning of Week 3. There will be weekend breaks between Modules. The total duration of METRA+ will be about 2.5 weeks.
We will assess monitor adherence to the intervention by monitoring session attendance and drop out.
Intervention code [1] 330065 0
Treatment: Other
Comparator / control treatment
As a pilot study this study will not include a comparator/control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340022 0
Self-reported symptoms of posttraumatic stress disorder (PTSD)
Timepoint [1] 340022 0
The primary time point is post-METRA+. Assessments will be at baseline, post-completion of METRA+ (primary timepoint) and 3-month follow-up.
Primary outcome [2] 340023 0
Self-reported symptoms of depression
Timepoint [2] 340023 0
The primary time point is post-METRA+. Assessments will be at baseline, post-completion of METRA+ (primary timepoint) and 3-month follow-up.
Secondary outcome [1] 442358 0
Social Skills
Timepoint [1] 442358 0
Assessments will be at baseline, post-completion of METRA+ and 3-month follow-up.
Secondary outcome [2] 442359 0
Symptoms of anxiety
Timepoint [2] 442359 0
Assessments will be at baseline, post-completion of METRA+ and 3-month follow-up.
Secondary outcome [3] 442360 0
Psychiatric Difficulties
Timepoint [3] 442360 0
Assessments will be at baseline, post-completion of METRA+ and 3-month follow-up.
Secondary outcome [4] 442745 0
Social Competence with Peers
Timepoint [4] 442745 0
Assessments will be at baseline, post-completion of METRA+ and 3-month follow-up.
Secondary outcome [5] 442746 0
Nonviolent Communication Behaviors
Timepoint [5] 442746 0
Assessments will be at baseline, post-completion of METRA+ and 3-month follow-up.

Eligibility
Key inclusion criteria
Afghan adolescents with a refugee background living in Pakistan 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2025
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26759 0
Pakistan
State/province [1] 26759 0

Funding & Sponsors
Funding source category [1] 317927 0
Charities/Societies/Foundations
Name [1] 317927 0
Mental Research Institute
Country [1] 317927 0
United States of America
Primary sponsor type
University
Name
Bard College
Address
Country
United States of America
Secondary sponsor category [1] 320275 0
University
Name [1] 320275 0
Monash University
Address [1] 320275 0
Country [1] 320275 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316612 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 316612 0
Ethics committee country [1] 316612 0
Australia
Date submitted for ethics approval [1] 316612 0
20/12/2024
Approval date [1] 316612 0
Ethics approval number [1] 316612 0

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

Contacts
Principal investigator
Name 138418 0
A/Prof Laura Jobson
Address 138418 0
Wellington Rd Clayton Monash University Melbourne 3800 Victoria
Country 138418 0
Australia
Phone 138418 0
+61 3 99053945
Fax 138418 0
Email 138418 0
Laura.Jobson@monash.edu
Contact person for public queries
Name 138419 0
Laura Jobson
Address 138419 0
Wellington Rd Clayton Monash University Melbourne 3800 Victoria
Country 138419 0
Australia
Phone 138419 0
+61 3 99053945
Fax 138419 0
Email 138419 0
Laura.Jobson@monash.edu
Contact person for scientific queries
Name 138420 0
Laura Jobson
Address 138420 0
Wellington Rd Clayton Monash University Melbourne 3800 Victoria
Country 138420 0
Australia
Phone 138420 0
+61 3 99053945
Fax 138420 0
Email 138420 0
Laura.Jobson@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.