Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000275864
Ethics application status
Approved
Date submitted
1/02/2021
Date registered
11/03/2021
Date last updated
2/05/2022
Date data sharing statement initially provided
11/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Harnessing Social Media and mHealth to manage adjustment to parenthood in fathers
Scientific title
Harnessing Social Media and mHealth to Predict, Monitor, and Intelligently Manage Depression, Anxiety and Stress in Paternal Perinatal Adjustment
Secondary ID [1] 303310 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal mental health 320533 0
Paternal postnatal depression 320985 0
Paternal postnatal anxiety 320986 0
Condition category
Condition code
Mental Health 318388 318388 0 0
Depression
Mental Health 318389 318389 0 0
Anxiety
Reproductive Health and Childbirth 318792 318792 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered via a smartphone app. The intervention is designed to address core paternal postpartum depression, anxiety, and stress symptoms and maintaining factors. There will be 4 modules to this intervention completed over 4 weeks, and participants will be asked to complete these modules in order. The content covering each module is as follows:
(1) a values clarification and goal setting module;
(2) a mindfulness meditation module, containing relaxation techniques to help manage mood;
(3) a cognitive restructuring module, assisting participants to increase positive thoughts, and manage negative thoughts; and
(4) a behavioural activation module, encouraging participants to increase their engagement in pleasant activities, e.g., activity planning, behaviour tracking.

Participants will be encouraged to commence each new module after around 7 days, although they will be instructed that they can go at a pace that suits them. Each module will take approximately 30mins to complete, and participants will be encouraged to implement the strategies prescribed in each module on a daily basis.

Each module will contain various audio recordings of a professional describing and guiding the intervention content and what is required; various quizzes to facilitate learning; text boxes for participants to read; and writing spaces for participants to record their thoughts, feelings and behaviors to certain exercises.

The app also contains additional resources, including a self-monitoring tool for daily mood monitoring (with feedback graphs) and psychoeducation materials designed specifically for this study educating participants on precipitating and perpetuating factors for paternal perinatal depression, anxiety and stress.

App-based notifications will be provided on a daily basis to enhance adherence to the intervention. Adherence to the intervention will be monitored through app usage analytics.
Intervention code [1] 319614 0
Prevention
Intervention code [2] 319897 0
Treatment: Devices
Comparator / control treatment
Wait-list control (participants will have access to the smartphone app after the intervention phase).

The wait-list will last 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 326368 0
Postnatal depression assessed using the Edinburgh Postnatal Depression Scale (EDPS)
Timepoint [1] 326368 0
Baseline, post-test (4 weeks post-baseline)
Primary outcome [2] 326369 0
DASS-21 Anxiety scores
Timepoint [2] 326369 0
Baseline, post-test (4 weeks post-baseline)
Primary outcome [3] 326370 0
DASS-21 Stress score
Timepoint [3] 326370 0
Baseline, post-test (4 weeks post-baseline)
Secondary outcome [1] 391221 0
Parenting Sense of Competence Scale
Timepoint [1] 391221 0
Baseline, post-test (4 weeks post-baseline)
Secondary outcome [2] 391222 0
Paternal Postnatal Attachment Scale
Timepoint [2] 391222 0
Baseline, post-test (4 weeks post-baseline)
Secondary outcome [3] 391224 0
Linguistic dimensions (e.g. language and grammar) assessed using the Linguistic Inquiry and Word Count (LIWC) from social media data
Timepoint [3] 391224 0
Baseline, post-test (4 weeks post-baseline)

Eligibility
Key inclusion criteria
(1) aged 18 or over;
(2) identify as a father;
(3) have an infant aged under 12 months of age;
(4) be a user and contributor to the social media platform Reddit;
(5) have sufficient English literacy;
(6) have access to an Android or iOS smartphone or tablet for the duration of the study; and
(7) be moderately symptomatic for depression, anxiety, or stress (EPDS, DASS)
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2021
Actual
24/03/2021
Date of last participant enrolment
Anticipated
30/11/2021
Actual
15/08/2021
Date of last data collection
Anticipated
31/01/2022
Actual
13/11/2021
Sample size
Target
150
Accrual to date
Final
166
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24743 0
New Zealand
State/province [1] 24743 0
All states/provinces
Country [2] 24744 0
United States of America
State/province [2] 24744 0
All states/provinces
Country [3] 24745 0
Canada
State/province [3] 24745 0
All states/provinces
Country [4] 24746 0
United Kingdom
State/province [4] 24746 0
All states/provinces

Funding & Sponsors
Funding source category [1] 307724 0
University
Name [1] 307724 0
Deakin University
Country [1] 307724 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 308423 0
None
Name [1] 308423 0
N/A
Address [1] 308423 0
N/A
Country [1] 308423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307751 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 307751 0
221 Burwood Hwy Burwood VIC 3125
Ethics committee country [1] 307751 0
Australia
Date submitted for ethics approval [1] 307751 0
21/05/2020
Approval date [1] 307751 0
15/07/2020
Ethics approval number [1] 307751 0
2020-151

Summary
Brief summary
Fathers' perinatal mental health is a major public health issue, but few fathers seek or are offered mental health support. Emerging evidence suggests that fathers prefer informal, digital methods of perinatal support, but currently few tools exist for them to access.

This research project aims to evaluate an app-based mindfulness-CBT intervention for fathers mental health using an RCT design. A secondary, exploratory aim is to investigate the usefulness of social media data for identifying fathers in-need of support.

The hypothesis is: Participants allocated to the smartphone intervention will experience significantly greater reductions in mental health symptoms, parenting self-efficacy, and infant bonding at post-test (4 weeks from baseline) relative to participants allocated to the wait-list control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108374 0
Dr Samantha Teague
Address 108374 0
James Cook University, 1 James Cook Drive Townsville QLD 4811
Country 108374 0
Australia
Phone 108374 0
+61 3 924 68440
Fax 108374 0
Email 108374 0
[email protected]
Contact person for public queries
Name 108375 0
Samantha Teague
Address 108375 0
James Cook University, 1 James Cook Drive Townsville Qld 4811
Country 108375 0
Australia
Phone 108375 0
+61 3 924 68440
Fax 108375 0
Email 108375 0
[email protected]
Contact person for scientific queries
Name 108376 0
Samantha Teague
Address 108376 0
James Cook University, 1 James Cook Drive Townsville Qld 4811
Country 108376 0
Australia
Phone 108376 0
+61 3 924 68440
Fax 108376 0
Email 108376 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.