ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Postnatal anxiety

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Reproductive Health and Childbirth

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]

Prevention

Intervention code [2]

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]

Clinically significant depressive symptomatology defined as an Edinburgh Postnatal Depression Scale score >12 at 6 months postpartum.

Timepoint [1]

in addition to 6 month, this will be collected online at 12 months postpartum.

Secondary outcome [1]

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]

in addition to 6 month, this will be collected online at 12 months postpartum.

Secondary outcome [2]

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]

6 months postpartum.

Secondary outcome [3]

Perception of partner support using the Postpartum Partner Support Scale.

Timepoint [3]

in addition to 6 month, this will be collected online at 12 months postpartum.

Secondary outcome [4]

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]

in addition to 6 month, this will be collected online at 12 months postpartum.

Secondary outcome [5]

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]

6 months postpartum.

Secondary outcome [6]

‘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]

6 months postpartum.

Secondary outcome [7]

Maternal perceptions of peer support using the Peer Support Evaluation Inventory (PSEI)

Timepoint [7]

6 months postpartum.

Secondary outcome [8]

Loneliness measured by UCLA Loneliness Scale (Version 3)

Timepoint [8]

in addition to 6 month, this will be collected online at 12 months postpartum.

Secondary outcome [9]

Peer volunteer perceptions using the Peer Volunteer Experience Questionnaire.

Timepoint [9]

At the end of the trial or when a peer volunteer discontinues.

Secondary outcome [10]

Infant feeding measured for ‘any’ and ‘only’ breast milk feeding in the last 24 hours and since birth, measured by maternal report.

Timepoint [10]

Secondary outcome [11]

Infant feeding measured for ‘any’ and ‘only’ breast milk feeding in the last 24 hours and since birth, measured by maternal report.

Timepoint [11]