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Trial registered on ANZCTR


Registration number
ACTRN12618000892213p
Ethics application status
Submitted, not yet approved
Date submitted
24/05/2018
Date registered
28/05/2018
Date last updated
1/09/2024
Date data sharing statement initially provided
1/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing and evaluating a parent-level intervention to address child mental health needs in humanitarian contexts
Scientific title
Developing and evaluating a parent-level intervention to address child mental health needs in humanitarian contexts
Secondary ID [1] 294912 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 307875 0
Condition category
Condition code
Mental Health 306923 306923 0 0
Anxiety
Mental Health 306924 306924 0 0
Depression
Mental Health 306925 306925 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A parent group consisting of six 2-hour sessions, once a week over six weeks. Providing psycho-education, psychological support and strategies to parents based on cognitive behavioural and attachment-based principles. Delivered by non-specialist staff (Community Mental Health Workers and Counsellors) working for Medecins sans Frontieres (MSF) in contexts of humanitarian crisis (Iraq, Syria and Democratic Republic of the Congo). Delivered face-to-face with groups of 8-12 parents / caregivers, at MSF run health clinics and community centres in each context. Adherence to the intervention will be monitored through recording parent attendance for each group session. Group Facilitators will participate in weekly supervision with the MSF Mental Health Activity Manager in each context to address any concerns regarding delivery of the intervention.
Intervention code [1] 301228 0
Treatment: Other
Intervention code [2] 301229 0
Behaviour
Comparator / control treatment
Waitlist control condition. The waitlist control condition will begin the group intervention after the intervention condition has completed the 6-week group intervention, and both conditions have completed outcome measures. This is a delay of 7 weeks.
Control group
Active

Outcomes
Primary outcome [1] 305908 0
Child mental health as assessed by change in scores on the Strengths and Difficulties Questionnaire - Parent Form (SDQ-P).
Timepoint [1] 305908 0
Pre-intervention (in the week prior to intervention commencing).
PRIMARY TIMEPOINT: Post-intervention (in the week following completion of the intervention).
12-week follow-up (12 weeks following the completion of the intervention).

Primary outcome [2] 305909 0
Child mental health as assessed by change in scores on the Child Revised Impact of Events Scales (CRIES-13).
Timepoint [2] 305909 0
Pre-intervention (in the week prior to intervention commencing).
PRIMARY TIMEPOINT: Post-intervention (in the week following completion of the intervention).
12-week follow-up (12 weeks following the completion of the intervention).
Primary outcome [3] 305910 0
Child wellbeing as assessed by change in scores on the Child Outcome Rating Scale (CORS) - child rated.
Timepoint [3] 305910 0
Pre-intervention (in the week prior to intervention commencing).
PRIMARY TIMEPOINT: Post-intervention (in the week following completion of the intervention).
12-week follow-up (12 weeks following the completion of the intervention).
Secondary outcome [1] 347068 0
ADDITIONAL PRIMARY OUTCOME: Child wellbeing as assessed by change in scores on the Child Outcome Rating Scale (CORS) - parent rated.
Timepoint [1] 347068 0
Pre-intervention (in the week prior to intervention commencing).
Session-by-session.
PRIMARY TIMEPOINT: Post-intervention (in the week following completion of the intervention).
12-week follow-up (12 weeks following the completion of the intervention).
Secondary outcome [2] 347069 0
Parent mental health as assessed by change in scores on the Self Reporting Questionnaire (SRQ-20).
Timepoint [2] 347069 0
Pre-intervention (in the week prior to intervention commencing).
Post-intervention (in the week following completion of the intervention).
12-week follow-up (12 weeks following the completion of the intervention).
Secondary outcome [3] 347071 0
Parent wellbeing as assessed by change in scores on the Outcome Rating Scale (ORS).
Timepoint [3] 347071 0
Pre-intervention (in the week prior to intervention commencing).
Session-by session.
Post-intervention (in the week following completion of the intervention).
12-week follow-up (12 weeks following the completion of the intervention).
Secondary outcome [4] 347072 0
Parental self-efficacy as assessed by change in scores on the Brief Parental Self-Efficacy Scale (BPSES).
Timepoint [4] 347072 0
Pre-intervention (in the week prior to intervention commencing).
Post-intervention (in the week following completion of the intervention).
12-week follow-up (12 weeks following the completion of the intervention).
Secondary outcome [5] 347074 0
Group Faciliatator experience of running the group assessed using a Group Facilitator Feedback Questionnaire developed for this research.
Timepoint [5] 347074 0
Post-intervention (in the week following completion of the intervention).
Secondary outcome [6] 347377 0
Group participant experience of the group, assessed using the Group Session Rating Scale (GSRS) and a Group Participant Feedback Questionnaire developed for this research.
Timepoint [6] 347377 0
GSRS: Session-by-session.
Group Feedback Questionnaire: Post-intervention (in the week following completion of the intervention).

Eligibility
Key inclusion criteria
Parents or primary caregivers of children aged 8-12 years.
Children aged 8-12 years.
Parents report concern regarding their child’s mental health or psychosocial functioning (this includes psychological, cognitive, emotional, behavioural and social concerns). (NB. There is no requirement for psychiatric diagnosis or clinical threshold on outcome measures to be met).
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents with severe mental illness (e.g., psychosis), severe emotional dysregulation (e.g., extreme aggression), current high risk of suicide, severe substance abuse, or other indicators that individual psychiatric/ psychological intervention is more appropriate as a primary intervention for the parent.
Parents who report their primary concern as related to developmental disabilities or neurological conditions (e.g., epilepsy), as these are not addressed by the intervention.

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)
Allocation completed by the holder of the allocation schedule who is 'off-site' and not involved in the recruitment or determination of a potential participant's eligibility status. Randomisation will be stratified by location - Iraq, Syria, and the Democratic Republic of the Congo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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
The sample size of the study is constrained by the number of participants per group (8-12), and the number of groups that would be able to run concurrently in each site based on staff availability (1-3 groups). It is estimated that 400 participants will be recruited over a 12 month period.
Allowing for an attrition rate of 10% results in 360 participants completing follow-up. Assuming a design effect of 1.2 to account for clustering in the study design, the estimated 360 participants results in an effective sample size of 300 (150 intervention, 150 control). Assuming 5% significance level and 80% power, detectable differences and standardised effect sizes were calculated for each primary outcome measure: SDQ-P, CORS, and CRIES-13 . These calculations were based on mean and standard deviation scores for each outcome measure as observed in previous research with populations as similar as possible to the population of the current research. On all primary outcome measures this study is powered to detect a standardised effect size of 0.32 or greater.

Descriptive statistics will be used to summarise each of the outcome measures by group, time point and geographic location.
For each outcome, generalized linear mixed models with random effect (participant-id on which randomisation is based) and categorical fixed effects group (intervention vs. control), time point (pre-intervention, post-intervention, follow-up) and group*time interaction will be used to assess the impact of intervention. Models will allow for clustering by geographic locations and will be adjusted for relevant confounding factors.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Given the complexities of conducting research in these humanitarian settings there were multiple delays due to challenges faced by the operational partner. These cumulative delays reached a stage where it was no longer feasible to commence the RCT as originally proposed.
Date of first participant enrolment
Anticipated
10/09/2018
Actual
Date of last participant enrolment
Anticipated
15/09/2019
Actual
Date of last data collection
Anticipated
24/01/2020
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 10498 0
Iraq
State/province [1] 10498 0
Kirkuk Governorate
Country [2] 10499 0
Iraq
State/province [2] 10499 0
Diyala Governorate
Country [3] 10500 0
Syrian Arab Republic
State/province [3] 10500 0
Ar-Raqqah Governorate
Country [4] 10501 0
Syrian Arab Republic
State/province [4] 10501 0
Aleppo Governorate
Country [5] 10502 0
Congo, The Democratic Republic Of The
State/province [5] 10502 0
North Kivu

Funding & Sponsors
Funding source category [1] 299494 0
Charities/Societies/Foundations
Name [1] 299494 0
Médecins sans Frontières
Country [1] 299494 0
Netherlands
Funding source category [2] 299563 0
University
Name [2] 299563 0
The Australian National University
Country [2] 299563 0
Australia
Primary sponsor type
University
Name
The Australian National University
Address
Contact Name: Sally Carter
Research School of Population Health
The Australian National University
Canberra ACT 2600 Australia
Country
Australia
Secondary sponsor category [1] 298797 0
Charities/Societies/Foundations
Name [1] 298797 0
Médecins sans Frontières
Address [1] 298797 0
Contact Name: Eleanor Hitchman
Médecins sans Frontières – Operational Centre Amsterdam
Naritaweg 10, 1043 BX, Amsterdam
The Netherlands
Country [1] 298797 0
Netherlands

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300398 0
Médecins sans Frontières Ethics Review Board
Ethics committee address [1] 300398 0
Ethics committee country [1] 300398 0
Switzerland
Date submitted for ethics approval [1] 300398 0
16/05/2018
Approval date [1] 300398 0
Ethics approval number [1] 300398 0
Ethics committee name [2] 300460 0
The Australian National University Human Research Ethics Committee
Ethics committee address [2] 300460 0
Ethics committee country [2] 300460 0
Australia
Date submitted for ethics approval [2] 300460 0
18/05/2018
Approval date [2] 300460 0
Ethics approval number [2] 300460 0

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

Contacts
Principal investigator
Name 83530 0
Ms Sally Carter
Address 83530 0
Research School of Population Health
College of Health & Medicine
The Australian National University
Bldg 62, Mills Road, Acton, ACT, 2601, Australia
Country 83530 0
Australia
Phone 83530 0
+61 2 6125 6984
Fax 83530 0
Email 83530 0
[email protected]
Contact person for public queries
Name 83531 0
Sally Carter
Address 83531 0
Research School of Population Health
College of Health & Medicine
The Australian National University
Bldg 62, Mills Road, Acton, ACT, 2601, Australia
Country 83531 0
Australia
Phone 83531 0
+61 2 6125 6984
Fax 83531 0
Email 83531 0
[email protected]
Contact person for scientific queries
Name 83532 0
Sally Carter
Address 83532 0
Research School of Population Health
College of Health & Medicine
The Australian National University
Bldg 62, Mills Road, Acton, ACT, 2601, Australia
Country 83532 0
Australia
Phone 83532 0
+61 2 6125 6984
Fax 83532 0
Email 83532 0
[email protected]

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.