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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]

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

Anxiety

Condition category

Condition code

Mental Health

Depression

Mental Health

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]

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]

A composite primary outcome will be assessed for depression, anxiety and distress as measured by the DASS 21.

Timepoint [1]

At entry to the study, six months post entry

Secondary outcome [1]

Depression assessed on sub scale of the DASS 21

Timepoint [1]

Six months post entry

Secondary outcome [2]

Anxiety sub scale of DASS 21

Timepoint [2]

Six months post entry

Secondary outcome [3]

Stress sub scale of DASS 21

Timepoint [3]

Six months post entry

Secondary outcome [4]

Parenting Sense of Confidence will be assessed using the Karitane Parenting Confidence Scale

Timepoint [4]

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]

Charities/Societies/Foundations

Name [1]

Defence Health Foundation

Address [1]

4/380 St Kilda Road, Melbourne, Vic, 3004

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

beyondblue

Address [2]

290 Burwood Rd Hawthorn 3122

Country [2]

Australia

Primary sponsor type

University

Name

University of Newcastle, NSW, Australia

Address

University Drive
Callaghan
NSW
2308

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HREC University of Newcastle

Ethics committee address [1]

University Drive
Callaghan NSW
2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/02/2016

Approval date [1]

16/06/2016

Ethics approval number [1]

H-2016-0055

Ethics committee name [2]

Australian Defence Human Research Ethics Committee

Ethics committee address [2]

CP3-6-036, Campbell Park Offices, PO Box 7912, Canberra BC ACT 2610

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

15/08/2019

Approval date [2]

16/08/2016

Ethics approval number [2]

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]

/AnzctrAttachments/370085-University of Newcastle HREC BC04 Expedited Approval.pdf (Ethics approval)

Attachments [2]

/AnzctrAttachments/370085-ADHREC 160816 - Protocol 823-16 - Ethical Approval.pdf (Ethics approval)

Contacts

Principal investigator

Name

A/Prof Richard Fletcher

Address

Family Action Centre
University of Newcastle
University Drive
Callaghan
NSW, 2308

Country

Australia

Phone

+61 2 49216401

Fax

[email protected]

Contact person for public queries

Name

Chris May

Address

Family Action Centre
University of Newcastle
University Drive
Callaghan
NSW, 2308

Country

Australia

Phone

+61 2 49217224

Fax

[email protected]

Contact person for scientific queries

Name

Richard Fletcher

Address

Family Action Centre
University of Newcastle
University Drive
Callaghan
NSW, 2308

Country

Australia

Phone

+61 2 49216401

Fax

[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

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Documents added automatically

No additional documents have been identified.

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