Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000321347
Ethics application status
Approved
Date submitted
1/02/2017
Date registered
28/02/2017
Date last updated
21/01/2022
Date data sharing statement initially provided
21/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Parenting from the start: Evaluating a preventative intervention to improve outcomes for mothers and babies
Scientific title
Parenting from the start: Evaluating a preventative intervention to improve outcomes for mothers and babies
Secondary ID [1] 290783 0
None
Universal Trial Number (UTN)
U111111840331
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maternal sensitivity and responsiveness 301399 0
Infant attachment security 301407 0
Birth outcomes / interventions (including instrumental and surgical birth) 301422 0
Infant feeding / breastfeeding 301423 0
Infant sleep practices 301424 0
Social support / alloparenting 302214 0
Condition category
Condition code
Public Health 301141 301141 0 0
Health promotion/education
Reproductive Health and Childbirth 301819 301819 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Antenatal parenting intervention

During pregnancy, intervention group participants will receive an antenatal parenting intervention involving an evidence-based parenting workshop plus a gifted sling. The 8-hour Parenting From the Start Pregnancy Workshop examines the basic needs of infants (stable, loving, responsive care by sensitive, reflective caregivers) and may be offered in a single day or split over two sessions. The non-judgemental, participatory format will provide parents with ideas about how they can be responsive, and get them thinking about how best to meet their baby’s needs within the constraints of modern life. The goal is to provide expectant mothers and their whanau with evidence-based information to facilitate informed decision making. The workshop does not involve giving advice or telling people how to parent.

The workshop includes a number of videos, discussions, and hands-on activities within the Keynote presentation format. The parenting topics discussed include early brain development, pregnancy, birth, infant feeding, skin-to-skin time following vaginal or surgical birth, infant sleep, infant toileting options, alloparenting (shared care by multiple adults), and early care. Content is informed by research evidence, and situated within the context of the evolved developmental niche (Narvaez, Fuentes, McKenna, & Valentino, 2014; Narvaez, Panksepp, Schore, & Gleason, 2012; Narvaez, Gleason, et al., 2013; Narvaez, Wang, et al., 2013). Participants will be encouraged to reflect on our origins as mammals, Homo sapiens and hunter-gatherers, and how parenting has changed over the 10-15,000 years since humans developed permanent settlements and agriculture, and diversified into modern cultural groups. Many strands of research suggest the ongoing importance of stable, loving, sensitive, and responsive care if babies are to grow up happy and healthy, and it has been suggested that this is the early environment human infants have evolved to expect.

The present intervention also replicates and extends a previous experiment which found that gifting mothers of newborns a soft baby carrier (‘sling’) significantly reduced infant crying, increased maternal sensitivity as rated by blind observers, and doubled the rates of secure attachment 13 months later (Anisfeld, Casper, Nozyce, & Cunningham, 1990). Thus, our intervention participants will be gifted a sling during pregnancy (at the end of the workshop) and shown how to use it safely. The slings to be gifted are 100% cotton, NZ-designed Moby Wraps, which come in a range of colours and fit men and women of all shapes and sizes, and infants up to 16.5kgs (most children weigh less than this at age 2).

Workshops will be designed and presented by the lead researcher, Leith Anna Pugmire, a registered clinical psychologist who has completed specialist training relating to attachment. Leith is also a mother-of-three with personal experience of pregnancy, labour, birth, and breastfeeding. She speaks conversational Maori (and has a Diploma in Te Ara Reo Maori from Te Wananga o Aotearoa) as well as being fluent in English.

The culturally-appropriate nature of the workshop will be extended by the use of appropriate Maori (indigenous NZ) practices such as beginning with a mihi (greeting) and a short, non-religious karakia. Whakatauki (Maori proverbs) and kupu (words) will also be used. Participants in each workshop will be provided with and hot lunch and snacks, which will be preceded by a karakia kai (Maori blessing performed prior to eating), and the gathering will begin with time set aside for whakawhanaungatanga (relationship building). In keeping with our acknowledgement of Maori as tangata whenua (the indigenous people) of Aotearoa New Zealand, the workshop draws on traditional Maori parenting for examples of sensitive and responsive caregiving. The negative impacts of Pakeha (European) colonisation are explicitly acknowledged.

The mode of delivery is face-to-face, and the workshops will take place at a variety of community venues around the Manawatu region such as health hubs and wananga (Maori tertiary education institutions). Each workshop is intended to include approximately 10 pregnant women, plus their partners, support people, and/or family/whanau members, although the number of participants may need to be adjusted to fit the demand at each locality. The presenter is expected to be sensitive to the needs of the people in each group and flexible in her presentation style – providing extra explanation or hands-on demonstration as appropriate. Each woman / couple / family will ‘adopt’ a lifesize, weighted baby doll for the day, to enable them to physically ‘try out’ various parenting practices in a safe and supportive atmosphere. Participants will be encouraged to seek further evidence-based information, such as by reading the book The Science of Parenting: How today’s brain research can help you raise happy, emotionally balanced children (2016) by Margot Sunderland.

Intervention adherence / fidelity will be assessed. At the conclusion of each workshop, a checklist will be completed by the presenter to indicate whether key topics were covered, and key process issues adhered to. Participants will complete a Workshop Feedback Form at the end of the workshop, providing the presenter with information about what is working and/or not working so that the workshop can be adjusted as appropriate.
Intervention code [1] 297013 0
Behaviour
Intervention code [2] 297014 0
Treatment: Other
Intervention code [3] 297015 0
Prevention
Comparator / control treatment
Participants who are assigned to the control group will experience standard care during pregnancy. That is, they will access the usual range of maternity care that is offered in the Manawatu region of New Zealand – unchanged by their participation in this study. They will not attend the Parenting From the Start Pregnancy Workshop or be gifted a sling.

Control group participants will be invited to attend a parenting workshop at the end of the study, in a ‘waiting list control’ design. Because their babies will be at least a year old at this point, the workshop they attend will differ from the one offered to intervention group participants. The control group workshop will still cover early infant brain development and the importance of sensitive and responsive care, but will focus on parenting choices during the toddler years rather than on research relating to newborns.

In place of a sling, the control group will be gifted the book What Every Parent Needs to Know: Love, nurture and play with your child by Margot Sunderland. Previously published as The Science of Parenting: How today’s brain research can help you raise happy, emotionally balanced children (2016), the first edition of this book won First Prize in the British Medical Association Medical Book awards 2007 Popular Medicine section. This book is based on scientific research and is fully referenced, but includes large colour photographs and diagrams, a magazine-style layout, and clear, easy to follow writing. These features make it a stand-alone resource that we expect to be helpful to parents for many years.
Control group
Active

Outcomes
Primary outcome [1] 300906 0
Maternal sensitivity and responsiveness (separate and composite scores or classifications based on 3 measures, all involving expert ratings based on a 60-120 minute home observation). Two established observational measures will be used: the Maternal Behavior Q-Sort (MBQS-mini) and Ainsworth Sensitivity Scales, plus another observational / interview measure purpose-designed for this study: Observational Measure of Sensitivity and Responsiveness (OMOSAR). All measures will be completed by a trained research assistant.
Timepoint [1] 300906 0
At home visit 6-12 months post birth
Primary outcome [2] 300907 0
% of infants securely attached to their mother on the Strange Situation Procedure (SSP). The SSP will be scored by a trained research assistant who is ‘blind’ to group allocation.
Timepoint [2] 300907 0
At lab assessment 11 to 20 months post birth. Note: timing of lab assessment will be delayed for infants born prematurely
Secondary outcome [1] 331161 0
Parenting intentions as measured by maternal responses to likert scales on purpose-designed questionnaire: Parenting Intentions Questionnaire (PIQ).
Timepoint [1] 331161 0
Administered twice as a pre-test and post-test immediately before and after workshop (same day).
Secondary outcome [2] 331162 0
Workshop feedback as measured by maternal responses to likert scales on purpose-designed Workshop Feedback Form. The feedback form also invites qualitative responses (comments, feedback).
Timepoint [2] 331162 0
Immediately after the workshop (same day)
Secondary outcome [3] 331163 0
% of infants admitted to the newborn intensive care unit as measured by maternal report on purpose-designed questionnaire: Parenting Strategies Questionnaire (PSQ).
Timepoint [3] 331163 0
6-12 months post birth
Secondary outcome [4] 331164 0
% of mothers reporting particular birth interventions (e.g. medication, forceps, caesarian sections) as measured by maternal report on purpose-designed questionnaire: Parenting Strategies Questionnaire (PSQ).
Timepoint [4] 331164 0
6-12 months post birth
Secondary outcome [5] 331165 0
% of infants who are partially / fully / exclusively breastfed at various ages according to mother’s report on purpose-designed questionnaires: Parenting Strategies Questionnaire (PSQ) and Evolved Developmental Niche Scale (EDN Scale).
Timepoint [5] 331165 0
At home visit 6-12 months post birth (PSQ), and during lab assessment 11-20 months post birth (EDN Scale).
Secondary outcome [6] 331166 0
% of mothers with scores of 10 or greater on the Edinburgh Postnatal Depression Scale (EPDS). Mean depression score on EPDS. This screening test is OPTIONAL, so may not be completed by all participants.
Timepoint [6] 331166 0
At home visit 6-12 months post birth.
Secondary outcome [7] 331167 0
% of mothers employing particular parenting strategies as measured by maternal responses to purpose-designed questionnaire: Parenting Strategies Questionnaire (PIQ), which includes 60 multi-choice and likert-type items.
Timepoint [7] 331167 0
At home visit 6-12 months post birth.
Secondary outcome [8] 331168 0
Mean scores on the purpose-designed Evolved Developmental Niche Scale (EDN Scale), measuring evolved parenting practices.
Timepoint [8] 331168 0
At lab assessment 11-20 months post birth.
Secondary outcome [9] 332072 0
Mean scores on Maternal Behavior Q-Sort (MBQS-mini). This measure will be completed by a trained research assistant based on a 60-120 minute home observation.
Timepoint [9] 332072 0
At home visit 6-12 months post-birth
Secondary outcome [10] 332073 0
Mean scores on Ainsworth Sensitivity Scales. This measure will be completed by a trained research assistant based on a 60-120 minute home observation.
Timepoint [10] 332073 0
At home visit 6-12 months post-birth.
Secondary outcome [11] 332074 0
Mean scores on the Observational Measure of Sensitivity and Responsiveness (OMOSAR), which was developed for this study. This measure will be completed by a trained research assistant based on a 60-120 minute home observation.
Timepoint [11] 332074 0
At home visit 6-12 months post-birth

Eligibility
Key inclusion criteria
This research will be conducted in the Manawatu region of Aotearoa New Zealand. Participants will be expectant mothers who enter the study during pregnancy and are happy for their baby to participate alongside them after birth. Additional criteria for participation include being able to read and write well in English (in order to complete the questionnaires), a permanent resident living within 60 minutes drive of Palmerston North (or staying there at least part-time), able to remain involved in the study until their baby is 12-18 months old, and anticipating a normal pregnancy and birth. The Screening Questionnaire outlines the inclusion/ exclusion criteria.

People who report serious or chronic health conditions on the Screening Questionnaire will be allowed to enter the study on a case-by-case basis if the research team decides the condition will not seriously interfere with their ability to benefit from the parenting intervention being trialed.
Minimum age
10 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People will not be able to take part if they are expecting a multiple birth (e.g. twins), are planning to adopt or foster a baby, or have serious health conditions likely to affect their pregnancy, birth, and/or parenting choices (in the view of the research team). Fathers and other partners or family members will be able to attend the workshop, but will not be able to enrol in the study.

The Screening Questionnaire includes follow-up questions asking for a description of the health condition affecting the mother and/or baby. The purpose of these questions is to gain sufficient information to make a judgement about the appropriateness of study participation. People will not be able to participate if they have serious mental or physical health issues or addictions that are likely to limit their ability to make use of the information and resources presented in the workshop.

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)
Yes. Potential participants will be given an Information Sheet once they have completed a Screening Questionnaire and met study criteria. Each Information Sheet will be placed in a sealed opaque envelope and numbered by a research assistant, and the envelopes will be handed out in pre-arranged random order by the lead researcher as people express interest in entering the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Yes. Potential participants will be given an Information Sheet once they have completed a Screening Questionnaire and met study criteria. Each Information Sheet will be placed in a sealed opaque envelope and numbered by a research assistant, and the envelopes will be handed out in pre-arranged random order by the lead researcher as people express interest in entering the study. This ‘allocation concealment’ prevents bias from influencing the recruitment process.

Simple randomisation. There will be four versions of the Information Sheet (A, B, C, & D), which will be given out in (pre-arranged) random order: Two for the intervention group (B & D) and two for the control group (A & C). Versions A & B are aimed at first-time mothers. Versions C & D are for women expecting a second or subsequent baby. Randomisation will be accomplished using two lists of random numbers generated by www.randomizer.org, with even numbers indicating assignment to an intervention group (Groups B or D) and odd numbers indicating assignment to a control group (Groups A or C). Separate randomisations for first-time mothers and those expecting a subsequent baby ensure nearly equal numbers from each group will end up in the intervention and control conditions. The randomisation website will be set to generate numbers in sets of 10 (i.e. 5 people out of every 10 will be assigned to the intervention group, and the other 5 to the control group), so that groups remain relatively equal in size even with small numbers of participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is the first study of its kind. We are aiming to recruit up to 200 mother-infant dyads (approximately 100 per group). A sample of even one quarter this size (50 dyads) is likely to produce useful findings in telling us what strategies local parents are utilising during their first year, but may not provide sufficient power for significance testing. The only prior study utilising a gifted sling intervention obtained significant results with a sample of 49 low-SES mothers (Anisfeld et al., 1990).

We intend to use a combination of descriptive statistics to describe the tools and strategies parents in our region are using and significance testing (e.g. t tests) to compare the intervention and control groups on each measure. We also plan to use linear regression to assess the predictive validity of our maternal sensitivity measures.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Time constraints associated with PhD candidature
Date of first participant enrolment
Anticipated
1/03/2017
Actual
1/03/2017
Date of last participant enrolment
Anticipated
31/08/2017
Actual
28/01/2018
Date of last data collection
Anticipated
31/07/2019
Actual
24/01/2020
Sample size
Target
200
Accrual to date
Final
57
Recruitment outside Australia
Country [1] 8522 0
New Zealand
State/province [1] 8522 0
Manawatu

Funding & Sponsors
Funding source category [1] 295478 0
University
Name [1] 295478 0
Massey University
Country [1] 295478 0
New Zealand
Funding source category [2] 295481 0
Charities/Societies/Foundations
Name [2] 295481 0
Te Hahi Tuhauwiri / Aotearoa New Zealand Religious Society of Friends (Quakers)
Country [2] 295481 0
New Zealand
Funding source category [3] 295483 0
Charities/Societies/Foundations
Name [3] 295483 0
Jaycee Trust
Country [3] 295483 0
New Zealand
Funding source category [4] 310607 0
Charities/Societies/Foundations
Name [4] 310607 0
Pakiaka Tupuora - Parenting From the Start Trust
Country [4] 310607 0
New Zealand
Primary sponsor type
Individual
Name
Leith Anna Pugmire
Address
School of Psychology
Massey University Manawatu Campus
Private Bag 11 222
Palmerston North 4442
New Zealand
Country
New Zealand
Secondary sponsor category [1] 294302 0
Individual
Name [1] 294302 0
Dr Shane Harvey (Primary PhD Supervisor)
Address [1] 294302 0
Psychology Clinic
Massey University Manawatu Campus
Private Bag 11 222
Palmerston North 4442
New Zealand
Country [1] 294302 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296811 0
Southern Health & Disability Ethics Committee (HDEC)
Ethics committee address [1] 296811 0
Ethics committee country [1] 296811 0
New Zealand
Date submitted for ethics approval [1] 296811 0
09/11/2016
Approval date [1] 296811 0
02/12/2016
Ethics approval number [1] 296811 0
16/STH/186

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1411 1411 0 0
/AnzctrAttachments/372053-Screening Questionnaire (1).pdf (Other)
Attachments [2] 1413 1413 0 0
/AnzctrAttachments/372053-Advertising Poster (v3.2).pdf (Other)

Contacts
Principal investigator
Name 71270 0
Ms Leith Anna Pugmire
Address 71270 0
School of Psychology
Massey University Manawatu Campus
Private Bag 11 222
Palmerston North 4442
New Zealand
Country 71270 0
New Zealand
Phone 71270 0
+64212548812
Fax 71270 0
NA
Email 71270 0
l.pugmire@netmail.co.nz
Contact person for public queries
Name 71271 0
Leith Anna Pugmire
Address 71271 0
School of Psychology
Massey University Manawatu Campus
Private Bag 11 222
Palmerston North 4442
New Zealand
Country 71271 0
New Zealand
Phone 71271 0
+64212548812
Fax 71271 0
NA
Email 71271 0
l.pugmire@netmail.co.nz
Contact person for scientific queries
Name 71272 0
Leith Anna Pugmire
Address 71272 0
School of Psychology
Massey University Manawatu Campus
Private Bag 11 222
Palmerston North 4442
New Zealand
Country 71272 0
New Zealand
Phone 71272 0
+64212548812
Fax 71272 0
NA
Email 71272 0
l.pugmire@netmail.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethical approval to share this data with anyone outside the research team


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14753Study protocol  l.pugmire@netmail.co.nz
14754Ethical approval    372053-(Uploaded-03-08-2021-13-25-32)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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