Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000402640p
Ethics application status
Submitted, not yet approved
Date submitted
2/12/2021
Date registered
19/04/2023
Date last updated
19/04/2023
Date data sharing statement initially provided
19/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of Livelihood and Psychosocial Training on Livelihood Outcomes
Scientific title
Randomised Controlled Trial of a Combined Psychosocial and Livelihood Program versus a Livelihood Program on Livelihood Outcomes in Iraq
Secondary ID [1] 307734 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor livelihood 324499 0
Anxiety 324500 0
Depression 324501 0
Condition category
Condition code
Mental Health 321983 321983 0 0
Anxiety
Mental Health 321984 321984 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial. Arm 1: Livelihood Program/Problem Management Plus. Arm 2: Livelihood Program. The Livelihood Program/Problem Management Plus involves training farmers individually in Iraq in farming and business practices. The training will involve provision of farming aid in terms of produce and technical training for a period of 1 year, followed by training in budgeting and utilising markets for 1 year. This livelihood training will be delivered to small groups of 3-5 farmers on 4 occasions, with each lasting 5-hour sessions. Adherence will be assessed by monitoring participants' attendance at the Livelihood sessions. Prior to the farming training, farmers will receive will receive Problem Management Plus, which involves 5 x 120-minute weekly group sessions teach the following stress coping strategies: anxiety reduction, problem solving, behavioral activation, and accessing social support. This will occur will in a face-to-face format, using educational sessions that teach cognitive behavioural strategies, using flipcharts and group discussions in groups of 8-10 farmers. The duration of the study for any participant will conclude after a 48-month follow-up assessment, resulting in participation duration of 214 weeks. Adherence will be assessed by monitoring participants' attendance at the Problem Management Plus sessions via a checklist maintained by the group facilitator.
Intervention code [1] 322312 0
Behaviour
Intervention code [2] 324212 0
Treatment: Other
Comparator / control treatment
The control condition will involve providing farmers with the Livelihood Program but not the Problem Management Plus sessions. The Livelihood Program involves training farmers individually in Iraq in farming and business practices. The training will involve provision of farming aid in terms of produce and technical training for a period of 1 year, followed by training in budgeting and utilising markets for 1 year. This livelihood training will be delivered to small groups of 3-5 farmers on 4 occasions, with each lasting 5-hour sessions. This livelihood training will be delivered across 6 group sessions that involve small group class teaching. The duration of the study for any participant will conclude after a 48-month follow-up assessment, resulting in participation duration of 214 weeks. Adherence will be assessed by monitoring participants' attendance at the Livelihood sessions.
Control group
Active

Outcomes
Primary outcome [1] 329739 0
Livelihood gains as measured by a composite measure of economic outcomes that includes annual yield of produce and annual income.
Timepoint [1] 329739 0
Pretreatment (week 0), week 52, week 104, week 156, and week 208 (primary timepoint) post-intervention commencement .
Secondary outcome [1] 403754 0
Anxiety and depression as measured by the Hospital and Anxiety Depression Scale.
Timepoint [1] 403754 0
Pretreatment (week 0), week 52, week 104, week 156, and week 208 post-intervention commencement .
Secondary outcome [2] 403755 0
Social integration as measured by the Practitioner Assessment of Network Type.
Timepoint [2] 403755 0
Pretreatment (week 0), week 52, week 104, week 156, and week 208 post-intervention commencement .
Secondary outcome [3] 403756 0
Disciplinary parenting as measured by the Alabama Parenting Questionnaire discipline subscale.
Timepoint [3] 403756 0
Pretreatment (week 0), week 52, week 104, week 156, and week 208 post-intervention commencement .

Eligibility
Key inclusion criteria
• Adults aged 18 years or above
• Residents in Iraq
• Farmers agreeing to receive farming training
• Arabic speaking
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Severe cognitive impairment
• Severe suicidal intent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be adults receiving farming training in Iraq. Participants 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)
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
Not applicable.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will focus primarily on intent-to-treat analysis. Using SPSS version 27, hierarchical linear mixed models (HLM) will be used to study differential effects of each condition because this method effectively handles missing data by calculating estimates of trajectories. For the follow-up analyses between the two conditions, analyses will focus on linear time effects, conditions, and interactions. Fixed effects parameters will be tested with the Wald test (t-test, p <.05, two-sided) and 95% confidence intervals. Cohen’s (d) effect size was calculated for all analyses. The primary outcome measure will be the composite livelihood outcome. The primary outcome timepoint will be the 208 week assessment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2023
Actual
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
720
Accrual to date
Final
Recruitment outside Australia
Country [1] 24367 0
Iraq
State/province [1] 24367 0
Mosul

Funding & Sponsors
Funding source category [1] 310267 0
Government body
Name [1] 310267 0
Australian NGO Cooperation Program
Country [1] 310267 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
World Vision Australia
Address
1 Vision Drive,
Burwood East,
VIC 3151
Country
Australia
Secondary sponsor category [1] 311367 0
None
Name [1] 311367 0
Address [1] 311367 0
Country [1] 311367 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309938 0
University of Mosul Ethics Committee
Ethics committee address [1] 309938 0
Ethics committee country [1] 309938 0
Iraq
Date submitted for ethics approval [1] 309938 0
07/03/2022
Approval date [1] 309938 0
Ethics approval number [1] 309938 0

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

Contacts
Principal investigator
Name 115910 0
Prof Richard Bryant
Address 115910 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 115910 0
Australia
Phone 115910 0
+61405375874
Fax 115910 0
Email 115910 0
[email protected]
Contact person for public queries
Name 115911 0
Richard Bryant
Address 115911 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 115911 0
Australia
Phone 115911 0
+61405375874
Fax 115911 0
Email 115911 0
[email protected]
Contact person for scientific queries
Name 115912 0
Richard Bryant
Address 115912 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 115912 0
Australia
Phone 115912 0
+61405375874
Fax 115912 0
Email 115912 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?
De-identified data of published results will be made available, as well as related data dictionaries
When will data be available (start and end dates)?
Data will be available following publication of the study outcomes. There is no end date for when this data will be available.
Available to whom?
Researchers wishing to conduct re-analyses of the data.
Available for what types of analyses?
Meta-analyses or re-analyses of subgroups
How or where can data be obtained?
By emailing the Principal Investigator (email: [email protected]).


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.