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ParentsNCT03679520

New Programme for Antenatal Preparation for Early Parenthood

A study testing New programme and Regular programme in people with Parents, run by Region Skane at 7 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Becoming a parent is a challenging stage in life, which provokes feelings of both excitement and insecurity; parents strive to develop confidence in their parenting role. Studies show that new parents often feel inadequately prepared for early parenthood which may have a negative impact on adjustment to life as a… Read more about this study

Who is it for?
Any age
Conditions the study is for
Parents
What is being tested?
New programme and Regular programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
7 sitesSweden
Study dates
3 Sep 2018to 31 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Expectant first-time parents
  • Intention to participate in group based antenatal parental preparation
  • Understand written and spoken Swedish

Who cannot join

  • -

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Sweden7 sites

  • Barnmorskemottagningen Dalby

    Dalby

  • Barnmorskorna Mitt i Skåne

    Höör

  • Barnmorskemottagningen Kävlinge

    Kävlinge

  • Barnmorskemottagningen Knislinge

    Knislinge

  • Barnmorskemottagningen Capio Singelgatan

    Malmö

  • Barnmorskemottagningen Capio Västra hamnen

    Malmö

  • Barnmorskemottagningen Granen

    Malmö

Other trials in Sweden

About this study

Official title: Antenatal Preparation for Early Parenthood: A Pilot Study of a Cluster Randomised Controlled Trial Evaluating a New Programme Based on First-time Parents' Preferences

Becoming a parent is a challenging stage in life, which provokes feelings of both excitement and insecurity; parents strive to develop confidence in their parenting role. Studies show that new parents often feel inadequately prepared for early parenthood which may have a negative impact on adjustment to life as a parent as well as health and wellbeing for the whole family.

The overall aim is to develop, pilot test and evaluate a new programme for antenatal preparation for the early parenthood period. The hypothesis is that expectant first-time parents who receive an intervention with a new programme for antenatal preparation for parenthood will show higher scores for parental self-efficacy in the early parenthood period than those who do not receive the intervention. The specific aims for the pilot study are:

Read more
  1. To assess the acceptability of the procedures for parents and providers (midwives)
  2. To estimate the likely rates of recruitment and retention of participants
  3. To estimate the effects on outcome measurements in order to calculate the appropriate sample size in a full scale randomized controlled trial (RCT).

Antenatal clinics will be randomised to either intervention group, and provide a new programme of antenatal parental preparation, or to control group and provide a regular programme of antenatal parental preparation. First-time expectant parents will be invited in early pregnancy by the midwives at the antenatal clinics to participate in the study by partaking in an evaluation of the different ways to provide antenatal parental preparation. Parents who agree to participate will receive postal questionnaires before the antenatal parental preparation start and approximately four weeks after giving birth.

Midwives working in antenatal clinics randomised to the intervention group will receive a one-day-education before providing the intervention antenatal parental preparation. These midwives will also receive questionnaires, after the education and after providing the antenatal parental preparation.

All midwives, in both control group and intervention group, providing antenatal parental preparation will be given a form with questions related to the content in the provided programme to fill in.

Read the detailed description

Development of the intervention; The development of the intervention was guided by the Medical Research Council's (MRC) framework for development and evaluation of complex interventions. The development phase involves identifying the evidence base, identifying or developing theory and modelling process and outcome. Based on reviews of literature and the results of previous studies in this project, the concept of self-efficacy in Social Cognitive Theory was identified as a suitable theory in the development and evaluation of the intervention.

Details of recruitment and randomisation of Antenatal clinics; Antenatal clinics (ANCs), which offer the most common model (regular) for antenatal parental preparation, as mapped out in a previous study, will be invited to participate in the pilot study which will compare the regular programme for antenatal parental preparation (control group) with a new programme for antenatal parental preparation (intervention group). Cluster randomisation of ANCs will be used to minimise contamination between the different programmes of antenatal preparation in the two groups. Randomisation will be stratified according to Care Need Index (CNI) which is based on socio-demographic variables of expectant mothers registered with the participating ANCs. A mean value of the CNIs of participating ANCs will be calculated, those below the mean value will form one strata and those above the mean value will form the other strata. Half of the ANCs will be randomised to the intervention group and half to the control group.

Details of preparations to provide the new programme intervention; A full-day education will be provided for midwives at the ANCs randomised to the intervention group which will include group leadership skills to facilitate peer learning among parents, evidence-based websites, framework for co-parenting and details regarding the new programme. The education to the midwives will be followed up with personal phone contact 1-2 months after the education, by the educator, in order to give opportunities for questions and clarifications in order to provide the intervention programme.

Conditions
Parents
Being tested
New programme, Regular programme
Keywords
Prenatal education, Parents, Randomized controlled trial, Self Efficacy, Depression, postpartum
Medical subject headings
Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • New programmeOther

    Time for topics related to the time after birth and in reversed chronological order to give an early and joint focus on parenthood for both parents. Involving new parents to share their experiences of early parenthood with expectant parents. Introducing and using evidence-based websites in the sessions A breastfeeding preparation that gives tools to meet common challenges in the initial phase of breastfeeding. Based on principles for adult learning.

    Sessions

    1. Introduction, life-change of becoming a parent and co-parenting
    2. Early parenthood
    3. Breastfeeding, caring for the baby and early parenthood
    4. and 5 Labour, birth and postnatal care

  • Regular programmeOther

    Antenatal parental preparation "as usual". As no guidelines exist the number of sessions may vary between 2 and 3 sessions and smaller variations in content may also occur.

    Sessions

    1. (or 1 and 2) Labour, birth and postnatal care
    2. or 3 Breastfeeding, caring for the baby and early parenthood
Study groups in NCT03679520
Study groupRoleWhat they receive
New programmeExperimentalA new programme of antenatal parental preparation provided by midwives to groups with 8-16 individuals. It will include 5 sessions á 2 hours and start in gestational week 25.
Receives: Other: New programme
Regular programmeActive comparatorA regular programme of antenatal parental preparation provided by midwives to groups of 8-16 individuals and encompassing between 5 and 7 hours of antenatal parental preparation.
Receives: Other: Regular programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Parent Expectations Survey

    The Parent Expectation Survey (PES) will be used to assess parental self-efficacy. PES exists in two versions, one for prenatal use and one for postnatal use. Both versions contain 25 items with statements related to their perceived parental skills, the phrasing of the statements in the prenatal version is prefaced with "I will…" and in the postnatal version "I can…" otherwise the statements are identical. The statements are answered on 11-point Likert-type scales ranging from 0 (Cannot do) to 10 (Certain can do). Total score range 0-250. Higher scores indicate higher parental self-efficacy. Statistical comparison will be made to assess the change of parental self-efficacy (total score) across time, from baseline to postnatal follow-up, and groups.

    Measured: 4 weeks postnatal

Secondary outcomes (2)

  1. The Parents' Postnatal Sense of Security Instrument

    The Parents Postnatal Sense of Security (PPSS) will be used to assess parental sense of security during the early postnatal period. PPSS exists in two versions, one for mothers and one for partners. Mothers' version contain 18 items within 4 dimensions, partners' version 13 items within 4 dimensions, answered on 4-point Likert-type scales (1-4)

    Mothers' version: total score range 18-72. Dimensions: a sense of the midwives'/nurses' empowering behaviour 6-24; a sense of general well-being 5-20; a sense of affinity within the family 4-16; and a sense that breast feeding was manageable 3-12.

    Partners': total score range 13-52. Dimensions: a sense of the midwives/nurses' empowering behaviour 5-20; a sense of the mother's general well-being including breastfeeding 3-12; a sense of general well-being 3-12; and a sense of affinity within in the family 2-8.

    Higher scores indicate higher sense of security. Statistical comparisons will be made at dimension levels and the total score level

    Measured: 4 weeks postnatal

  2. The Edinburgh Postnatal Depression Scale

    The Edinburgh Postnatal Depression Scale (EPDS) will be used to assess risk of postnatal depression. EPDS is a 10-item self-report scale specifically designed to screen for postnatal depression in community samples. Each item is scored on a four-point scale (score 0-3), the total score range is 0-30. The risk for postnatal depression increases as scores increase. Statistical comparisons will be made at the total score level.

    Measured: 4 weeks postnatal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2018
  2. Study start3 Sep 2018
  3. Primary completion31 Oct 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Antenatal clinics randomised to control group provide antenatal parental preparation as usual (regular programme) to expectant parents and antenatal clinics randomised to intervention group provide a new programme of antenatal parental preparation to expectant parents.
Masking
Single blind
Who is masked
Participant
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03679520
Sponsor's protocol ID
2017/746
Status last verified
Nov 2019
First submitted
3 Sep 2018
Last updated
13 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reece SM. The parent expectations survey: a measure of perceived self-efficacy. Clin Nurs Res. 1992 Nov;1(4):336-46. doi: 10.1177/105477389200100404.

    PubMed 1483137

  • Persson EK, Fridlund B, Dykes AK. Parents' postnatal sense of security (PPSS): development of the PPSS instrument. Scand J Caring Sci. 2007 Mar;21(1):118-25. doi: 10.1111/j.1471-6712.2007.00442.x.

    PubMed 17428223

  • Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

    PubMed 3651732

  • MRC (2006). Developing and evaluating complex interventions: new guidance. Medical Research Council. Available [2018-08-28] at https://www.mrc.ac.uk/documents/pdf/complex-interventions-guidance/

  • Entsieh AA, Hallstrom IK. First-time parents' prenatal needs for early parenthood preparation-A systematic review and meta-synthesis of qualitative literature. Midwifery. 2016 Aug;39:1-11. doi: 10.1016/j.midw.2016.04.006. Epub 2016 Apr 28.

    PubMed 27321714

  • Palsson P, Persson EK, Ekelin M, Kristensson Hallstrom I, Kvist LJ. First-time fathers experiences of their prenatal preparation in relation to challenges met in the early parenthood period: Implications for early parenthood preparation. Midwifery. 2017 Jul;50:86-92. doi: 10.1016/j.midw.2017.03.021. Epub 2017 Mar 31.

    PubMed 28399472

  • Palsson P, Kvist LJ, Ekelin M, Hallstrom IK, Persson EK. "I Didn't Know What to Ask About": First-Time Mothers' Conceptions of Prenatal Preparation for the Early Parenthood Period. J Perinat Educ. 2018 Jun;27(3):163-174. doi: 10.1891/1058-1243.27.3.163.

    PubMed 30364409

  • Feinberg ME. Coparenting and the transition to parenthood: a framework for prevention. Clin Child Fam Psychol Rev. 2002 Sep;5(3):173-95. doi: 10.1023/a:1019695015110.

    PubMed 12240706

  • Bandura, A. (1997). Self-efficacy: the exercise of control. New York: W. H. Freeman and Company.

  • Barimani M, Vikstrom A, Rosander M, Forslund Frykedal K, Berlin A. Facilitating and inhibiting factors in transition to parenthood - ways in which health professionals can support parents. Scand J Caring Sci. 2017 Sep;31(3):537-546. doi: 10.1111/scs.12367. Epub 2017 Jan 31.

    PubMed 28144992

  • Svensson J, Barclay L, Cooke M. Randomised-controlled trial of two antenatal education programmes. Midwifery. 2009 Apr;25(2):114-25. doi: 10.1016/j.midw.2006.12.012. Epub 2007 Apr 24.

    PubMed 17459542

Questions about this trial

What is this clinical trial studying?

A study testing New programme and Regular programme in people with Parents, run by Region Skane at 7 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Parent Expectations Survey (time frame: 4 weeks postnatal). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03679520, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.

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