Clinical trial NCT03679520: New Programme for Antenatal Preparation for Early Parenthood
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parents
Keywords: Prenatal education
Parents
Randomized controlled trial
Self Efficacy
Depression, postpartum
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2018-09-20
Enrollment: 71
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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 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:

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: The Parent Expectations Survey
timeFrame: 4 weeks postnatal
Secondary outcomes:
measure: The Parents' Postnatal Sense of Security Instrument
timeFrame: 4 weeks postnatal
measure: The Edinburgh Postnatal Depression Scale
timeFrame: 4 weeks postnatal
Other outcomes:
Locations:
city: Dalby
country: Sweden
facility: Barnmorskemottagningen Dalby
city: Höör
country: Sweden
facility: Barnmorskorna Mitt i Skåne
city: Knislinge
country: Sweden
facility: Barnmorskemottagningen Knislinge
city: Kävlinge
country: Sweden
facility: Barnmorskemottagningen Kävlinge
city: Malmö
country: Sweden
facility: Barnmorskemottagningen Capio Singelgatan
city: Malmö
country: Sweden
facility: Barnmorskemottagningen Capio Västra hamnen
city: Malmö
country: Sweden
facility: Barnmorskemottagningen Granen
Study officials:
affiliation: Lund University
name: Linda J Kvist, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Bandura, A. (1997). Self-efficacy: the exercise of control. New York: W. H. Freeman and Company.
citation: 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.
citation: 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.