Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001029785
Ethics application status
Approved
Date submitted
7/07/2022
Date registered
22/07/2022
Date last updated
22/07/2022
Date data sharing statement initially provided
22/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
DadBooster: A Randomised Controlled Trial of an Online Depression Treatment for New Fathers
Scientific title
DadBooster: A Randomised Controlled Trial of the Efficacy of an Online Depression Treatment for New Fathers
Secondary ID [1] 307426 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 326775 0
Anxiety 326776 0
Condition category
Condition code
Mental Health 323996 323996 0 0
Depression
Mental Health 323997 323997 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
DadBooster Internet-based treatment: Participants allocated to the intervention will receive the DadBooster Internet-based treatment program. This is an interactive online cognitive-behavioural therapy program developed to treat paternal postnatal depression. It consists of 6 online sessions to be completed one per week (over 6-9 weeks). Each session takes approximately 30 minutes to work through. The program also includes additional content in the form of eight information articles that can be accessed at any time, at the participant's own discretion. The articles cover the following topics: the couple relationship, communication skills, sleep and caring for baby, sensing baby's needs, managing time, managing stress, getting support, and problem solving (each around 5-10 minutes to read). The program includes a Partner Support Website that participants can invite their partners to access. Partners can access this at their own discretion. The Partner Support Website contains information for partners on paternal postnatal depression and caring for oneself and baby. The information is presented in the form of text and images and can be read in 10-20 minutes. Participants allocated to the intervention will also receive regular SMS messages to encourage and motivate them to continue using the program (11 messages in total over 6 weeks, approximately 2 per week). A letter will be sent to each participant's GP informing the GP of their participation in the study and diagnosis. Website analytic tools and database flags will allow collection of program usage data in an unobtrusive manner, generating records of number and duration of visits to the program website and number of program sessions completed.
Intervention code [1] 323917 0
Treatment: Other
Comparator / control treatment
Waitlist control: A letter will be sent to each participant's GP informing the GP of their participation in the study and diagnosis. Support and/or referral to other services will then occur as necessary, as usually happens in circumstances in which specialised programs are not available. Participants allocated to the Waitlist control condition will receive the DadBooster Internet-based treatment program, as described above, after completing their 12-week follow-up questionnaires and assessment.
Control group
Active

Outcomes
Primary outcome [1] 331863 0
Mean depression score on the Depression Anxiety Stress Scales
Timepoint [1] 331863 0
12-weeks post-enrolment
Primary outcome [2] 331938 0
Diagnosed depressive episode on the SCID-5
Timepoint [2] 331938 0
12-weeks post-enrolment
Secondary outcome [1] 411396 0
Mean anxiety score on the Depression Anxiety Stress Scales
Timepoint [1] 411396 0
9-weeks and 12-weeks post-enrolment
Secondary outcome [2] 411397 0
Mean stress score on the Depression Anxiety Stress Scales
Timepoint [2] 411397 0
9-weeks and 12-weeks post-enrolment
Secondary outcome [3] 411398 0
Mean behavioural activation on the Behavioural Activation for Depression Scale
Timepoint [3] 411398 0
9-weeks and 12-weeks post-enrolment
Secondary outcome [4] 411399 0
Mean negative thoughts on the Automatic Thoughts Questionnaire
Timepoint [4] 411399 0
9-weeks and 12-weeks post-enrolment
Secondary outcome [5] 411400 0
Mean relationship quality on the Dyadic Adjustment Scale-7
Timepoint [5] 411400 0
9-weeks and 12-weeks post-enrolment
Secondary outcome [6] 411401 0
Mean parenting self-efficacy on the Parenting Sense of Competence Scale
Timepoint [6] 411401 0
9-weeks and 12-weeks post-enrolment
Secondary outcome [7] 411402 0
Mean depression on the Patient Health Questionnaire-9
Timepoint [7] 411402 0
2-weeks, 4-weeks, 9-weeks and 12-weeks post-enrolment

Eligibility
Key inclusion criteria
Diagnosis of current major or minor depressive episode; 6 weeks to 1 year postpartum; a Patient Health Questionnaire-9 score > 9; ability to understand English; familiarity with the Internet and e-mail; home Internet access; able/willing to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Current substance use disorder; bipolar disorder; psychotic disorder; current moderate to high risk of suicide; current treatment for depression (medication or psychotherapy); or symptoms of PTSD.

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 concealment will be ensured by a central, computer-automated administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An automated permuted block (block sizes of 2, 4, and 6) allocation schedule has been pregenerated by a computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the outcome measure of depression symptom severity, data from a previous trial of cognitive-behavioural therapy for postnatal depression (Milgrom et al 2005) provided relevant estimates of variability in baseline scores. Per power calculations below, we aim for a total sample size of N = 50 to achieve sufficient power to detect a clinically important difference in the primary measure of depressive symptom severity. A sample size of n = 50 gives 80% power to detect a large effect size of d = 0.8, at alpha = 0.05 in an analysis of variance. As such, the required n=15.7(8.09/6.5)2 = 24.3, which rounds to 25 per group. Continuous outcomes (e.g., symptom severity) will be analysed with random-effects regression models, accommodating time independent and dependent covariates, fixed and random factors, and incomplete data. Consistent with CONSORT standards, all analyses of our primary outcomes will adhere to intention-to-treat principles and will involve planned contrasts of intervention vs. control. We will explore baseline and clinical characteristics associated with depression outcomes, acceptability, program adherence.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311701 0
Charities/Societies/Foundations
Name [1] 311701 0
Ian Potter Foundation
Country [1] 311701 0
Australia
Funding source category [2] 311737 0
Charities/Societies/Foundations
Name [2] 311737 0
Perpetual Philanthropy
Country [2] 311737 0
Australia
Funding source category [3] 311738 0
Charities/Societies/Foundations
Name [3] 311738 0
Men of Malvern
Country [3] 311738 0
Australia
Funding source category [4] 311739 0
Charities/Societies/Foundations
Name [4] 311739 0
Baker Foundation
Country [4] 311739 0
Australia
Primary sponsor type
Individual
Name
Professor Jeannette Milgrom
Address
Parent-Infant Research Institute
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights Victoria 3081
Country
Australia
Secondary sponsor category [1] 313157 0
None
Name [1] 313157 0
Address [1] 313157 0
Country [1] 313157 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311153 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 311153 0
Ethics committee country [1] 311153 0
Australia
Date submitted for ethics approval [1] 311153 0
Approval date [1] 311153 0
31/08/2021
Ethics approval number [1] 311153 0
HREC/73980/Austin-2021

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

Contacts
Principal investigator
Name 120130 0
Prof Jeannette Milgrom
Address 120130 0
Parent-Infant Research Institute
Heidelberg Repatriation Hospital,
Centaur Building, Level 1
300 Waterdale Road, (PO Box 5444) Heidelberg West, Vic 3081
Country 120130 0
Australia
Phone 120130 0
+61 3 9496 4009
Fax 120130 0
Email 120130 0
[email protected]
Contact person for public queries
Name 120131 0
Charlene Holt
Address 120131 0
Parent-Infant Research Institute
Heidelberg Repatriation Hospital,
Centaur Building, Level 1
300 Waterdale Road, (PO Box 5444) Heidelberg West, Vic 3081
Country 120131 0
Australia
Phone 120131 0
+61 3 9496 4496
Fax 120131 0
Email 120131 0
[email protected]
Contact person for scientific queries
Name 120132 0
Alan Gemmill
Address 120132 0
Parent-Infant Research Institute
Heidelberg Repatriation Hospital,
Centaur Building, Level 1
300 Waterdale Road, (PO Box 5444) Heidelberg West, Vic 3081
Country 120132 0
Australia
Phone 120132 0
+61 3 9496 4496
Fax 120132 0
Email 120132 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?
Individual participant data underlying published results
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal determined on a case-by-case basis at the discretion of Principal Investigator
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator: [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.