Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000261415
Ethics application status
Approved
Date submitted
22/02/2016
Date registered
25/02/2016
Date last updated
19/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of the SMS4dads text messaging program in reducing depression and anxiety in new fathers, a randomised controlled trial.
Scientific title
Efficacy of the SMS4dads text messaging program in reducing depression and anxiety in new fathers, a randomised controlled trial.
Secondary ID [1] 288589 0
Nil KNown
Universal Trial Number (UTN)
U1111-1179-9232
Trial acronym
not applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 297732 0
Anxiety 297750 0
Condition category
Condition code
Mental Health 297916 297916 0 0
Depression
Mental Health 297931 297931 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group fathers are sent supporting text messages 14 times per month from enrollment (any time from 16 weeks gestation to 3 months after their baby's birth) until the baby is 12 months old.

Messages address a father's relationship with his partner, his child and with himself with the aim of building strong father-child bonds, supporting strong parenting partnerships, and helping fathers to monitor and manage their mental health.

Fathers receive a text every 3 weeks asking them how well they are travelling. If their response is in the positive range they receive encouragement, If their response is tending to the negative they are forwarded information about support services, If their response is at the end of the negative range an escalation process is activated that either links them to online support or connects them with a phone counselor experienced in supporting fathers in the perinatal period - depending on the father's preference.

Mothers participation is limited to completion of the DASS 21 at entry to the study. Mothers do not receive any text messages.

Software - built into the system - monitors messages sent, links used, and responses to the mood tracker questions. The system reports these data automatically to the project managers.
Intervention code [1] 293986 0
Prevention
Comparator / control treatment
Control group fathers receive two generic health message per fortnight for 6 months, after which they will receive the same messages as those on the intervention arm, up until 12 months after the birth
Control group
Placebo

Outcomes
Primary outcome [1] 297434 0
A composite primary outcome will be assessed for depression, anxiety and distress as measured by the DASS 21.
Timepoint [1] 297434 0
At entry to the study, six months post entry
Secondary outcome [1] 321045 0
Depression assessed on sub scale of the DASS 21
Timepoint [1] 321045 0
Six months post entry
Secondary outcome [2] 321046 0
Anxiety sub scale of DASS 21
Timepoint [2] 321046 0
Six months post entry
Secondary outcome [3] 321077 0
Stress sub scale of DASS 21
Timepoint [3] 321077 0
Six months post entry
Secondary outcome [4] 321078 0
Parenting Sense of Confidence will be assessed using the Karitane Parenting Confidence Scale
Timepoint [4] 321078 0
Six months post entry

Eligibility
Key inclusion criteria
over 18 years of age and expecting a child with their partner. Must have a mobile phone that can receive text messages.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
< 18 years of age

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)
Allocation concealment by central computer generated randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation.
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
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Paired T test of total scores and subscale scores on psychometric surveys.

Sample size was based on the primary outcome of DASS-21 values in the intervention and control arms at 24 weeks, adjusting for baseline values. We assume an effect size of 0.5 Standard Deviation Units (Cohen’s d) among those ‘distressed’ fathers who report Moderate, Severe or Extremely Severe scores on the total DASS-21 (= 43). Aiming for power of 80%, significance level of 5%, 1:1 ratio of allocation to control and intervention, we estimate a sample size of 64 ‘distressed’ fathers will be required in each arm of the trial. Assuming 20% of the sample recruited will be distressed (based on Feasibility study data [45]) we will require 320 fathers in each arm giving a total sample of 640 fathers. Allowing 20% for attrition and loss to follow-up 800 fathers in total will be required to be recruited.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/05/2016
Actual
15/11/2016
Date of last participant enrolment
Anticipated
30/09/2017
Actual
Date of last data collection
Anticipated
30/06/2018
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292938 0
Charities/Societies/Foundations
Name [1] 292938 0
Defence Health Foundation
Country [1] 292938 0
Australia
Funding source category [2] 296774 0
Charities/Societies/Foundations
Name [2] 296774 0
beyondblue
Country [2] 296774 0
Australia
Primary sponsor type
University
Name
University of Newcastle, NSW, Australia
Address
University Drive
Callaghan
NSW
2308
Country
Australia
Secondary sponsor category [1] 291702 0
None
Name [1] 291702 0
Address [1] 291702 0
Country [1] 291702 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294443 0
HREC University of Newcastle
Ethics committee address [1] 294443 0
University Drive
Callaghan NSW
2308
Ethics committee country [1] 294443 0
Australia
Date submitted for ethics approval [1] 294443 0
29/02/2016
Approval date [1] 294443 0
16/06/2016
Ethics approval number [1] 294443 0
H-2016-0055
Ethics committee name [2] 297997 0
Australian Defence Human Research Ethics Committee
Ethics committee address [2] 297997 0
CP3-6-036, Campbell Park Offices, PO Box 7912, Canberra BC ACT 2610
Ethics committee country [2] 297997 0
Australia
Date submitted for ethics approval [2] 297997 0
15/08/2019
Approval date [2] 297997 0
16/08/2016
Ethics approval number [2] 297997 0
ADHREC/OUT/2016/R26707512

Summary
Brief summary
The perinatal period is a risky time for the mental health of fathers and this has important
implications for them and their families. Fathers who experience psychological distress in the perinatal period are often isolated, unsupported, and uninformed about the need to seek help and how to go about it.

Following previous research demonstrating that message content, and the processes used to operate SMS4dads are acceptable to fathers during their transition to parenthood, this
multi-centre randomised controlled trial (RCT) aims to test the efficacy of SMS4dads. In this
study the investigators will assess, using validated scales, the influence that SMS4dads has on key indicators of how well a father is coping with the transition to parenthood. These indicators include paternal depression, anxiety and distress, a sense of co-parenting quality, perceptions of parenting confidence, and reported alcohol consumption. Fathers will complete surveys at entry to the study, after 6 months and at 12 months after their child is born.

Participants will be randomised into either an intervention arm (where they will receive
messages and links, identical to those used in the previous phases of this research from 16 weeks pregnant to 12 months after birth) or to a control – wait list – arm, where they receive generic health messages for six months before being switched to recive intervention messages.. The intervention messages will provide fathers with information, motivation and practical advice on his relationships with his child, his partner and himself. Fathers, in the intervention arm will also be asked to keep track of their mood during the study by submitting information to SMS4dads on how well they are travelling. When fathers submit this information they will receive texts, of encouragement or support, which have been tailored to the response options. If this information indicates that a father is experiencing high levels of psychological distress an escalation system will be activated linking him to perinatal services offering telephone based counseling and support. The aim of this component of the project is to offer appropriate services to those in need but to also test whether fathers who report high levels of distress take the opportunity to access these services.

Mothers will also be invited to participate if their partner is enrolled. The project will assess
maternal distress at one time point (entry) to determine interactions between the intervention and levels of maternal depression, anxiety, and distress.
Trial website
https://www.sms4dads.com/

Note that this is the current website for SMS4dads from which a feasibility trial has been running. This website will be replicated (in most part) for the present proposal.
Trial related presentations / publications
Public notes
Attachments [1] 1305 1305 0 0
/AnzctrAttachments/370085-University of Newcastle HREC BC04 Expedited Approval.pdf (Ethics approval)
Attachments [2] 1306 1306 0 0
/AnzctrAttachments/370085-ADHREC 160816 - Protocol 823-16 - Ethical Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 63398 0
A/Prof Richard Fletcher
Address 63398 0
Family Action Centre
University of Newcastle
University Drive
Callaghan
NSW, 2308
Country 63398 0
Australia
Phone 63398 0
+61 2 49216401
Fax 63398 0
Email 63398 0
[email protected]
Contact person for public queries
Name 63399 0
Dr Chris May
Address 63399 0
Family Action Centre
University of Newcastle
University Drive
Callaghan
NSW, 2308
Country 63399 0
Australia
Phone 63399 0
+61 2 49217224
Fax 63399 0
Email 63399 0
[email protected]
Contact person for scientific queries
Name 63400 0
A/Prof Richard Fletcher
Address 63400 0
Family Action Centre
University of Newcastle
University Drive
Callaghan
NSW, 2308
Country 63400 0
Australia
Phone 63400 0
+61 2 49216401
Fax 63400 0
Email 63400 0
[email protected]

No information has been provided regarding IPD availability


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.