Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000307202
Ethics application status
Approved
Date submitted
22/02/2018
Date registered
1/03/2018
Date last updated
15/05/2020
Date data sharing statement initially provided
15/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Psychosocial intervention for mental health
Scientific title
Psychosocial intervention to improve mental health, social support, and help-seeking behaviours among abused pregnant women: A mixed method study from Nepal
Secondary ID [1] 294134 0
Nil
Universal Trial Number (UTN)
U1111-1209-7236
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 306753 0
Condition category
Condition code
Public Health 305841 305841 0 0
Health promotion/education
Mental Health 305898 305898 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of
a. A counselling and education session lasting about 30-40 minutes in the ANC clinic. This one time counselling session will be conducted individually. The session will adhere to the key skills of effective counselling and follow the guidelines provided by the WHO for working with women subjected to DV (WHO 2013, 2014). The researcher is a trained counselor and has previous experience of working with victims of DV. All of the counselling session will be delivered by the same person which will contribute to intervention fidelity. The intervention delivery guide has been prepared and it includes instructions for conducting the intervention and sample scripts to facilitate discussion. This is believed to ensure consistency in the intervention delivery. . This guide is not prescriptive, rather indicative and attempts will be made to conduct the session in a natural conversational style responding to the woman’s individual needs. All topics may not be covered in same depth with every single woman as different women may have different needs, however the student researcher will ensure that the key points outlined in intervention delivery guide are covered.
b. An information booklet has been prepared for this study after critical analysis of existing literature. The content of the booklet has been adapted from "A clinical handbook" by WHO for working with victims of domestic violence and a guide of "Problem management Plus" which deals with promoting mental health of those in adversity including domestic violence. An information booklet will consist of information about stressful life events, stress and problems managing technique, safety planning, social support, and contact details of emergency and support services.
c. Telephone support: Women will be provided with an access to contact the researcher during the study (till child is 6 weeks old) if they need assistance in managing their daily stressors or any advice and support. There is no maximum or minimum number of telephone support sessions. Women can call any time and/or frequency depending on their individual needs
Intervention code [1] 300420 0
Prevention
Intervention code [2] 300421 0
Rehabilitation
Intervention code [3] 300422 0
Behaviour
Comparator / control treatment
Participants allocated to the standard care group will receive regular ANC care according to the hospital protocol. In addition they will be provided with a booklet containing general information about pregnancy and a contact list of locally available support services. At the end of the study, the women in the control group can have access to the booklet provided to the women in the intervention group by contacting the ANC staff.
Control group
Active

Outcomes
Primary outcome [1] 304895 0
Mental health measured using Hospital Anxiety and Depression scale validated in Nepali. It consist of 14 items and each item is scored in a four-point Likert scale.
Timepoint [1] 304895 0
One month after the intervention commencement
Secondary outcome [1] 343552 0
Mean self efficacy score measured using Generalized Self Efficacy Scale consisting of 10 items. Each item will be scored on a four point likert scale.
Timepoint [1] 343552 0
Baseline, 4 weeks after the intervention commencement, 6 weeks postpartum
Secondary outcome [2] 343553 0
Perceived social support measured using 5 item Medical Outcomes Study Social Support Scale where each item will be scored on a 5-point Likert scale.
Timepoint [2] 343553 0
Baseline, 4 weeks after the intervention commencement, 6 weeks postpartum
Secondary outcome [3] 343554 0
Use of safety behaviors will be assessed using checklist that is adapted from McFarlane et al., 2002 and it has been modified to meet the local context.
Timepoint [3] 343554 0
Baseline, 4 weeks after the intervention commencement, 6 weeks postpartum
Secondary outcome [4] 343555 0
Help seeking behaviors assessed using self constructed questionnaire asking the participants whether they have used community resources related to domestic violence in past 3 months or not.
Timepoint [4] 343555 0
Baseline, 4 weeks after the intervention commencement, 6 weeks postpartum

Eligibility
Key inclusion criteria
Women will be included in the study if they i) are aged 18 years or older; ii) are 24-34 weeks pregnant; iii) have an identified history of ever experiencing DV in their life using the Abuse Assessment Screening (AAS) tool (at least one affirmative response in AAS); iv) can read and understand Nepali language; and v) have access to a telephone.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women will be excluded from the study if they i) are at risk of ending their life; ii) are displaying severe mental health disorders (psychotic disorders and substance dependence); iii) have severe cognitive impairment (severe intellectual disability or dementia); or iv) have hearing impairment.

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)
Sealed opaque envelopes will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequence number using block sizes of 2 and 4 will be developed from MS Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
G*Power was used to calculate sample size for the trial. Since, no studies were found to be similar to the proposed study, the study will follow Cohen’s recommendation on effect size, as well as take into consideration physical and financial constraints, to estimate the number of participants required for the given study. Assuming power of 80%, with alpha level 0.05, two-tailed, and medium effect size (0.5) for differences between two independent means; a total of 128 subjects are required. The sample size has been inflated by 10% as expected attrition rate. As a result, the final estimate for overall sample is 140, 70 in each group. Continuous data will be compared across the groups using independent t-test while categorical data will be analysed using chi-square test at each time points. ANCOVA will be used to assess the impact of intervention on primary outcome with adjustment of covariates such as baseline measurement and group allocation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2018
Actual
6/06/2018
Date of last participant enrolment
Anticipated
31/08/2018
Actual
27/08/2018
Date of last data collection
Anticipated
31/01/2019
Actual
28/01/2019
Sample size
Target
140
Accrual to date
Final
140
Recruitment outside Australia
Country [1] 9615 0
Nepal
State/province [1] 9615 0

Funding & Sponsors
Funding source category [1] 298768 0
University
Name [1] 298768 0
Griffith University
Country [1] 298768 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Logan Campus, Griffith University, Meadowbrook, QLD 4131, Australia
Country
Australia
Secondary sponsor category [1] 297953 0
None
Name [1] 297953 0
Address [1] 297953 0
Country [1] 297953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299709 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 299709 0
Ethics committee country [1] 299709 0
Australia
Date submitted for ethics approval [1] 299709 0
15/02/2018
Approval date [1] 299709 0
07/06/2018
Ethics approval number [1] 299709 0
Ethics committee name [2] 300648 0
Nepal Health Research Council
Ethics committee address [2] 300648 0
Ethics committee country [2] 300648 0
Nepal
Date submitted for ethics approval [2] 300648 0
23/02/2018
Approval date [2] 300648 0
13/03/2018
Ethics approval number [2] 300648 0
73/2018
Ethics committee name [3] 300649 0
BP Koirala Institute of Health Sciences
Ethics committee address [3] 300649 0
Ethics committee country [3] 300649 0
Nepal
Date submitted for ethics approval [3] 300649 0
03/04/2018
Approval date [3] 300649 0
01/06/2018
Ethics approval number [3] 300649 0
IRC/1250/018

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

Contacts
Principal investigator
Name 81358 0
Mrs Diksha Sapkota
Address 81358 0
Logan campus Griffith University
68 University Drive
MEADOWBROOK QLD 4131
Country 81358 0
Australia
Phone 81358 0
+61733821037
Fax 81358 0
Email 81358 0
[email protected]
Contact person for public queries
Name 81359 0
Diksha Sapkota
Address 81359 0
Logan campus Griffith University
68 University Drive
MEADOWBROOK QLD 4131
Country 81359 0
Australia
Phone 81359 0
+61733821037
Fax 81359 0
Email 81359 0
[email protected]
Contact person for scientific queries
Name 81360 0
Diksha Sapkota
Address 81360 0
Logan campus Griffith University
68 University Drive
MEADOWBROOK QLD 4131
Country 81360 0
Australia
Phone 81360 0
+61733821037
Fax 81360 0
Email 81360 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
Participants' details have been de-identified and considering the sensitive nature of the topic and ethical obligations, only the summary measures will be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7961Study protocolSapkota, D., Baird, K., Saito, A., Rijal, P., Pokharel, R., & Anderson, D. (2019). Counselling-based psychosocial intervention to improve the mental health of abused pregnant women: a protocol for randomised controlled feasibility trial in a tertiary hospital in eastern Nepal. BMJ Open, 9(4).  



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.