Clinical trial NCT02736136: An Early Intervention to Increase Maternal Self-efficacy After Preterm Birth
Official title: An Early Intervention to Increase Maternal Self-efficacy After Preterm Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Stress
Anxiety
Depression
Keywords: maternal parenting self-efficacy
parental stress
maternal sensitivity
mother-infant bond
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the effects of an early intervention (joint observation and video feedback) on maternal parenting self-efficacy following a premature birth. Mothers who have given birth to a very premature baby will be randomly allocated to either the early intervention or usual care whilst the infant is still hospitalized. Participants will be followed up at one month and six months. It is predicted that participants who received the early intervention will report higher maternal parenting self-efficacy than those who are not.


Eligibility criteria: Inclusion Criteria:

* Mothers of very preterm infants born between 28 and 32 weeks of gestation
* Infant aged up to 8 weeks

Exclusion Criteria:

* Do not speak French sufficiently well to participate in assessments
* Have established intellectual disability or psychotic illness
* Infant too instable regarding hemodynamic or respiratory functioning (severe brady apnea, more than 30% oxygen)

Primary outcomes:
measure: Perceived Maternal Parenting Self-Efficacy tool
timeFrame: 1 month
Secondary outcomes:
measure: Posttraumatic Diagnostic Scale
timeFrame: 1 month, 6 months
measure: Parental Stressor Scale: Neonatal Intensive Care Unit
timeFrame: 1 month, 6 months
measure: Parental Stress Index - Short form
timeFrame: 1 month, 6 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 1 month, 6 months
measure: Edinburgh Postnatal Depression Scale
timeFrame: 1 month, 6 months
measure: Mother-to-Infant Bonding Scale
timeFrame: 1 month, 6 months
measure: Infant Behaviour Questionnaire - Revised very short form
timeFrame: 1 month, 6 months
measure: Emotional Availability Scale
timeFrame: 6 months
measure: Perceived Maternal Parental Self-Efficacy tool
timeFrame: 6 months
measure: CARE-Index
timeFrame: 6 months
Other outcomes:
measure: Satisfaction with intervention questionnaire
timeFrame: 1 month
Locations:
city: Lausanne
country: Switzerland
facility: Neonatology Service, University Hospital Lausanne
state: Vaud
Study officials:
affiliation: Clinical and Research Psychologist
name: Antje Horsch, DClinPsych
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lovey O, Bickle-Graz M, Morisod Harari M, Horsch A, Schneider J; JOIN Research Consortium. The Joint Observation in Neonatology and Neurodevelopmental Outcome of Preterm Infants at Six Months Corrected Age: Secondary Outcome Data from a Randomised Controlled Trial. Children (Basel). 2022 Sep 13;9(9):1380. doi: 10.3390/children9091380.
citation: Schneider J, Borghini A, Morisod Harari M, Faure N, Tenthorey C, Le Berre A, Tolsa JF, Horsch A; JOIN Research Consortium. Joint observation in NICU (JOIN): study protocol of a clinical randomised controlled trial examining an early intervention during preterm care. BMJ Open. 2019 Mar 30;9(3):e026484. doi: 10.1136/bmjopen-2018-026484.