Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000684123
Ethics application status
Approved
Date submitted
30/04/2019
Date registered
7/05/2019
Date last updated
5/07/2024
Date data sharing statement initially provided
7/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing postnatal depression and anxiety in new mothers using telephone peer support: a randomised controlled trial.
Scientific title
Preventing postnatal depression and anxiety in new mothers using telephone peer support: a randomised controlled trial.
Secondary ID [1] 296143 0
NHMRC Project Grant no. 1141284.
Universal Trial Number (UTN)
Trial acronym
DAISY (Depression and AnxIety peer Support studY)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal depression 309730 0
Postnatal anxiety 312389 0
Condition category
Condition code
Mental Health 308539 308539 0 0
Depression
Mental Health 310942 310942 0 0
Anxiety
Reproductive Health and Childbirth 311210 311210 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Telephone peer support - Mothers allocated to the intervention group will receive proactive telephone-based support from a peer volunteer (mother-to-mother), in addition to all standard community services.
The trial coordinator will give mothers’ names and contact details to the volunteer coordinator. Peers will initiate early telephone support (within 48 to 72 hours of study recruitment if a woman recruited from a maternal and child health (MCH) centre or within one to two weeks after birth if a woman recruited in hospital after the birth), with a suggested schedule of contacts, but the duration and intensity of the intervention will be flexible based upon maternal desire and need. Telephone contact will proceed as per the set call schedule provided to peer volunteers until the mother is 6 months postpartum. The suggested schedule is telephone calls at weekly intervals for 8 weeks, then every 2 weeks until 6 months postpartum, with flexibility to meet women’s requirements; not all peer support relationships may need to continue for the entire period, and the number of calls may not be the key factor affecting outcomes. There is no restriction (i.e. minimum or maximum) on duration of each phone call. Other communication e.g. texts and emails can be used if both the new mother and peer desire.
Peer volunteers will provide appraisal support (helping women appraise their situation, make informed decisions) and emotional support by telephone, thus targeting key risk factors for depression and anxiety, i.e. social isolation and a lack of support. They will also provide information and suggestions about available existing clinical and support services. The goal is to support overcoming help-seeking barriers, not to provide mental health treatment i.e. this proactive approach will lead to more mothers recognising they have a concern or issue, and being referred for (or seeking) support in a timely manner. The focus will be to offer support and a listening ear, and provide women with details of existing local services as needed. If a volunteer considers that the mental health of a mother she is supporting is deteriorating she will consult with the volunteer coordinator (who will consult with the trial perinatal psychiatrist as needed) and refer the mother as appropriate.
Peer volunteers are mothers who are empathetic, want to support other mothers, and who have a history of (and have recovered from) postnatal depression and/or anxiety) (self-reported or diagnosed). It is important that peers have a lived experience of this condition, as this promotes empathy, trust, and help-seeking behaviours, and support provided by those who have experienced a similar health problem or stressor has a positive effect on psychological well-being. Recruitment of volunteers will be by advertisements in local newspapers, flyers in MCH Centres, word of mouth and social media.
Peer volunteers will undergo an initial 4-hour group training session with 2 follow-up group sessions, the first soon after they have supported their initial woman for 4 weeks. Training will be conducted by the DAISY research team in conjunction with PANDA perinatal Depression & Anxiety Australia educator. The focus of the training will be to develop skills required to provide effective telephone-based support and make appropriate referrals as necessary. Role playing will be a key strategy, and the importance of being non-judgemental, empathic, recognising boundaries and the need for self-care will be addressed. A detailed education package has been developed. A handbook, designed specifically for this study, will be given to peer volunteers, with topics such as how to develop a relationship; skills and techniques for effective telephone support; general perinatal mental health information; and referral pathways. Information on how to respond to a mother who may be experiencing a mental health crisis or who discloses intimate partner violence (IPV), something we expect may come up during support conversations, given its strong association with postnatal depression, will be discussed and prepared for. A module on responding to disclosure of IPV will be included in the training.
All peer volunteers agreeing to participate will be assigned an ID number, asked to complete a demographic form, and given activity logs. Activity logs will be used to assess intervention fidelity. Volunteers will be reimbursed $50/woman supported to cover the costs of telephone calls and incidentals. After the education, volunteers who seem unsuitable to provide peer support (as assessed by the volunteer coordinator and the chief investigator present at training, e.g. those with inadequate communication skills or who demonstrate evidence of unresolved depression or anxiety) will not continue to RCT participation, and where required, referrals will be made as needed to appropriate support services. Acceptance as a volunteer will be finalised only after initial training. Peers will sign a confidentiality agreement.
A paid volunteer coordinator will organise recruitment of peer volunteers (interview, screen for suitability); (2) help with peer volunteer training sessions; (3) match mothers with appropriate peer volunteer; (4) monitor intervention implementation; and (5) provide support to peer volunteers.
The volunteer coordinator will be available to provide support, assistance with any potential participant difficulties, and problem-solving strategies. Regular meetings between volunteers, coordinator and CIs will ensure the volunteers are well supported and taking self-care measures, and will facilitate intervention fidelity. Volunteers will be able to contact the volunteer coordinator and CIs by telephone at other times for information, advice or support.
Intervention code [1] 312472 0
Prevention
Intervention code [2] 314385 0
Behaviour
Comparator / control treatment
Usual care (comparison group). Mothers allocated to usual care will have access to all standard community postpartum services, including ongoing support from their local maternal and child health nurse (MCHN). Additional postpartum services available for mothers to actively seek assistance include general practitioners (GPs), midwives, paediatricians, psychologists, and the PANDA Perinatal Anxiety and Depression Australia helpline. All women scoring > 9 on the EPDS will be managed according to Victorian MCHN practice guidelines, e.g. being provided resources and referred for further mental health assessment.
Control group
Active

Outcomes
Primary outcome [1] 307519 0
Clinically significant depressive symptomatology defined as an Edinburgh Postnatal Depression Scale score >12 at 6 months postpartum.
Timepoint [1] 307519 0
in addition to 6 month, this will be collected online at 12 months postpartum.
Secondary outcome [1] 352178 0
Emotional states of anxiety and stress measured using the Depression Anxiety Stress Scales-21 (DASS-21) (only sub-scales of anxiety and stress).
Timepoint [1] 352178 0
in addition to 6 month, this will be collected online at 12 months postpartum.
Secondary outcome [2] 352179 0
health related quality of life, measured by the EuroQol 5D-3L (EQ-5D-3L), It will be used in the cost-effectiveness evaluation.
in addition to 6 month, this will be collected online at 12 months postpartum.
Timepoint [2] 352179 0
6 months postpartum.
Secondary outcome [3] 352181 0
Perception of partner support using the Postpartum Partner Support Scale.
Timepoint [3] 352181 0
in addition to 6 month, this will be collected online at 12 months postpartum.
Secondary outcome [4] 352182 0
self-rated parenting will be measured by:
(a) a single item global rating of the parent’s perception of themselves as being a ‘good’ parent, ranging from ‘1’ being a ‘Not very good’ parent to ‘5’ being a ‘Very good’ parent.
Timepoint [4] 352182 0
in addition to 6 month, this will be collected online at 12 months postpartum.
Secondary outcome [5] 352183 0
Child health and development measured by maternal report at 6 months on:
a) any child health problems and hospital visits/admissions since birth.
Timepoint [5] 352183 0
6 months postpartum.
Secondary outcome [6] 352184 0
‘Health costs’ as a composite outcome - will be measured by self-report using study-specific resource use questions adapted from the Patient Cost Questionnaire. Data will include use of Medicare-rebated (e.g. prescriptions, GP consultations, psychiatric consultations, psychological counselling) and non-Medicare-rebated health service use (e.g. routine and additional visits with MCHNs, hospital admissions, ambulance use, and complementary health care) since birth.
Resources used in intervention delivery including hours of volunteer input and consultations with the trial psychiatrist, will be recorded by project staff and peer activity logs. Resource and service use will be costed using existing unit costs (e.g. Medicare fee schedule).
An economic cost for volunteer time will be imputed based on average wage rates. Training costs will be treated as a capital item with the total cost annuitized over time.
Timepoint [6] 352184 0
6 months postpartum.
Secondary outcome [7] 352352 0
Maternal perceptions of peer support using the Peer Support Evaluation Inventory (PSEI)
Timepoint [7] 352352 0
6 months postpartum.
Secondary outcome [8] 369295 0
Loneliness measured by UCLA Loneliness Scale (Version 3)
Timepoint [8] 369295 0
in addition to 6 month, this will be collected online at 12 months postpartum.
Secondary outcome [9] 369823 0
Peer volunteer perceptions using the Peer Volunteer Experience Questionnaire.
Timepoint [9] 369823 0
At the end of the trial or when a peer volunteer discontinues.
Secondary outcome [10] 437160 0
Infant feeding measured for ‘any’ and ‘only’ breast milk feeding in the last 24 hours and since birth, measured by maternal report.
Timepoint [10] 437160 0
Secondary outcome [11] 437161 0
Infant feeding measured for ‘any’ and ‘only’ breast milk feeding in the last 24 hours and since birth, measured by maternal report.
Timepoint [11] 437161 0
6 months and 12 months postpartum
Secondary outcome [12] 437162 0
Self-rated parenting:
(b) parents’ confidence, measured using four items (scoring from 1 to 10) which are summed and averaged to give a total score ranging from 1-10.
Timepoint [12] 437162 0
6 months and 12 months postpartum
Secondary outcome [13] 437163 0
Self-rated parenting:
(b) parents’ confidence, measured using four items (scoring from 1 to 10) which are summed and averaged to give a total score ranging from 1-10.
Timepoint [13] 437163 0
6 months and 12 months postpartum
Secondary outcome [14] 437164 0
Self-rated parenting:
(c) parental warmth, measured using six items (scoring from 1 to 5), assessing parents’ expression of warmth, affection and enjoyment with the child.
Timepoint [14] 437164 0
6 months and 12 months postpartum
Secondary outcome [15] 437165 0
Self-rated parenting:
(c) parental warmth, measured using six items (scoring from 1 to 5), assessing parents’ expression of warmth, affection and enjoyment with the child.
Timepoint [15] 437165 0
6 months and 12 months postpartum
Secondary outcome [16] 437166 0
Self-rated parenting:
(d) parental irritability, measured using five items (scoring from 1 to 5) about frequency of parental anger and irritability toward the child.
Timepoint [16] 437166 0
6 months and 12 months postpartum
Secondary outcome [17] 437167 0
Self-rated parenting:
(d) parental irritability, measured using five items (scoring from 1 to 5) about frequency of parental anger and irritability toward the child.
Timepoint [17] 437167 0
6 months and 12 months postpartum
Secondary outcome [18] 437168 0
Child health and development measured by maternal report at 6 months on:
(b) infant temperament, using four items relating to settling the baby (e.g., soothing), and baby behaviour (e.g., crying), with scores being averaged across four items.
Timepoint [18] 437168 0
6 months and 12 months postpartum
Secondary outcome [19] 437169 0
Child health and development measured by maternal report at 6 months on:
(b) infant temperament, using four items relating to settling the baby (e.g., soothing), and baby behaviour (e.g., crying), with scores being averaged across four items.
Timepoint [19] 437169 0
6 months postpartum

Eligibility
Key inclusion criteria
Mothers with (1) a live birth, where neither mother or baby is extremely unwell; (2) any of the following risk factors: history of mental health issues (diagnosed or self-reported) previous to pregnancy or during pregnancy; scored greater than 9 and less or equal to 20 on the EPDS in pregnancy, or if scored < 9, but responded 1 to the EPDs self-harm question in pregnancy; obvious signs of anxiety/agitation at recruitment; social isolation; single mother; previous Sudden Infant Death Syndrome (SIDS); previous Fetal death in utero (FDIU); previous stillborn infant; (3) an ability to speak and understand English; and (4) accessible by telephone.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Infant not expected to be (or was not) discharged home at time of recruitment; (2) current use of anti-depressant, anti-anxiety or anti-psychotic medication; (3) women with major/serious mental health condition (e.g. bipolar, psychosis, schizophrenia, personality disorder); (4) women who respond 2 or above to the EPDS self-harm question; (5) severe alcohol or illicit drug use; (6) current experience of family violence; or (7) multiple birth.

Prior self-reported mental illness (e.g. prior postnatal depression or anxiety) will not be an exclusion criterion if the woman is stable.

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Women will be randomly allocated to the intervention or control group, with stratification by a) recruitment site; b) parity; and c) self-reported previous history of depression, including postnatal depression. A secure, password-protected, computerised randomisation schedule will be designed and administered by an independent service, accessed by phone or internet by recruiting staff. The randomisation ratio will be 1:1 peer support to usual care, with block sizes of 4 or 6 distributed randomly. Blocks will be pre-assigned to strata.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Victorian population-based data show that 17% of women had probable depression at 6 months postpartum. Our sample will be women screened as at increased risk of depression and thus is likely to have higher than population levels of depression at 6 months. We estimate that 25% of women in the control group will have probable depression (score >12 on the EPDS) at 6 months postpartum. To detect a decrease of 8% (i.e. to the population rate of 17%), with 80% power, and a two tailed a of 0.05, a sample of 862 is required. Allowing 15% loss to follow-up 1014 (or approximately 507/group) women need to be enrolled. To take into account the potential clustering effect of peer volunteers, we estimated an intra-cluster correlation (ICC) of 0.03, based on our recently completed cluster RCT in the same population, to inflate the sample size to allow for this adjustment in the outcome analysis. The variance inflation factor (IF =1+(m-1)*ICC [where m = average cluster size]) was calculated as 1.045 (1+(2.5-1)*0.03). Thus the final required sample size is 1060 (1014*1.045) (or approximately 530/group), which also allows detection of clinically meaningful differences in all secondary outcomes.

Data will be collected to meet the CONSORT guidelines. We will first check the baseline comparability of the groups, then the intervention group will be compared with the control group for all trial hypotheses using intention-to-treat analyses. The proportion of women scoring > 12 on the EPDS at 6 months will be compared for the primary outcome. Relative risks (RR) and 95% confidence intervals will be estimated. Regression analyses will adjust for the potential clustering, all stratification variables, and for any differences in the key demographic characteristics at baseline. For other outcomes, comparison of means will be undertaken using t-tests where data are normally distributed, or medians compared using Mann-Whitney U tests used if not. For binary variables RR and 95% CIs will be calculated. STATA will be used for data analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/05/2019
Actual
24/05/2019
Date of last participant enrolment
Anticipated
30/06/2023
Actual
28/06/2024
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
1060
Accrual to date
Final
1078
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16657 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 16658 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 30253 0
3052 - Parkville
Recruitment postcode(s) [2] 30254 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 300727 0
Government body
Name [1] 300727 0
National Health and Medical Research Centre
Country [1] 300727 0
Australia
Funding source category [2] 300743 0
University
Name [2] 300743 0
La Trobe University
Country [2] 300743 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University, Melbourne Campus
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 302553 0
None
Name [1] 302553 0
Address [1] 302553 0
Country [1] 302553 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301509 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 301509 0
Ethics committee country [1] 301509 0
Australia
Date submitted for ethics approval [1] 301509 0
11/07/2018
Approval date [1] 301509 0
06/12/2018
Ethics approval number [1] 301509 0
HEC18337
Ethics committee name [2] 301522 0
Department of Education and Training
Ethics committee address [2] 301522 0
Ethics committee country [2] 301522 0
Australia
Date submitted for ethics approval [2] 301522 0
30/07/2018
Approval date [2] 301522 0
29/08/2018
Ethics approval number [2] 301522 0
Ethics committee name [3] 315643 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [3] 315643 0
Ethics committee country [3] 315643 0
Australia
Date submitted for ethics approval [3] 315643 0
29/08/2019
Approval date [3] 315643 0
22/10/2019
Ethics approval number [3] 315643 0
HREC-A 166/19
Ethics committee name [4] 315644 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [4] 315644 0
Ethics committee country [4] 315644 0
Australia
Date submitted for ethics approval [4] 315644 0
06/11/2019
Approval date [4] 315644 0
02/12/2019
Ethics approval number [4] 315644 0
19/35 (SSA 19/18)
Ethics committee name [5] 315645 0
Northern Health
Ethics committee address [5] 315645 0
Ethics committee country [5] 315645 0
Australia
Date submitted for ethics approval [5] 315645 0
03/07/2020
Approval date [5] 315645 0
04/08/2020
Ethics approval number [5] 315645 0
SSA/56592

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

Contacts
Principal investigator
Name 87242 0
Prof Della Forster
Address 87242 0
La Trobe University, Melbourne Campus
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country 87242 0
Australia
Phone 87242 0
+61 3 9479 8783
Fax 87242 0
Email 87242 0
d.forster@latrobe.edu.au
Contact person for public queries
Name 87243 0
Della Forster
Address 87243 0
La Trobe University, Melbourne Campus
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country 87243 0
Australia
Phone 87243 0
+61 3 9479 8783
Fax 87243 0
Email 87243 0
d.forster@latrobe.edu.au
Contact person for scientific queries
Name 87244 0
Della Forster
Address 87244 0
La Trobe University, Melbourne Campus
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country 87244 0
Australia
Phone 87244 0
+61 3 9479 8783
Fax 87244 0
Email 87244 0
d.forster@latrobe.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7924Study protocolCitation will be provided when the protocol paper is published.https://www.latrobe.edu.au/jlc/research/mother-and-infant-health/daisyt.shafiei@latrobe.edu.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.