Clinical trial NCT02803866: Training Parenting Self-efficacy in Parents of Hospitalized Preterm Neonates
Official title: Assessing Parenting Self-efficacy Before and After Applying a Specific Training Program for Parents (CAP-PREM: Preterm Capacitation) During Hospitalization of Preterm Neonates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parenting
Preterm Infants
Training Support
Keywords: Parenting Self-efficacy
Parent training program
Perceived self-efficacy tool
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 16
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of hospitalized preterm neonates

Brief summary: In a hospital environment, initial parenting of a family with a preterm neonate will be very different than expected. This unusual and stressful situation may determine the self-confidence perceived by mothers and fathers in caring their baby and therefore could shape future interaction with him/her as well as neurodevelopmental and behavioral development of preterm infants.

24/7 neonatal units allow parents stay with their baby whenever they want but this free access nor guarantee neither encourage parenting self-efficacy if it isn't hand in hand with a specific training program for parents.

Detailed description: Longitudinal, prospective, analytic cohort study of parents of preterm newborns who will receive a specific training program for caring their preterm newborns during hospitalization. Families will be recruited during the first 10 days of hospitalization. The PMP S-E (Perceived Maternal Parenting Self- Efficacy) tool developed by Barnes and Adamson-Macedo, will be used to measure self-efficacy in providing infant care by mother or both mother and father. The training program will be developed at bed side by nurses and neonatologist covering theoretical and practical sessions during the first 25 days of hospitalization.

Hypothesis principal: Parents of hospitalized preterm neonates will get better score after application of a specific training program (CAP-PREM).

Secondary hypothesis:

* There is a correlation between the level of stress and anxiety in parents at admission and discharge and the results of PMP S-E score after the CAP-PREM program
* To assess those selected demographic variables that can predict a better result in PMP S-E score after the CAP-PREM program

Eligibility criteria: Inclusion Criteria:

* Preterm infants between 25 and 32 weeks of gestation,
* parents stay at the unit for at least 8 hours/day during training program
* fluent Spanish.
* parents age \> 18 years
* No clinical instability, invasive mechanical ventilation, intraventricular hemorrhage \>II or necrotizing enterocolitis .
* no congenital malformation nor chromosomal abnormalities

Exclusion criteria :

* No possibility of survival beyond the first week of life
* Admission less than 4 weeks
* No collaboration / lack of parental compliance
* wish of parents to leave the study

Primary outcomes:
measure: Perceive parental self-efficacy before and after CAP-PREM program
timeFrame: 4 weeks
Secondary outcomes:
measure: Influence of parents' psychological state in acquiring self-efficacy
timeFrame: 4 weeks
measure: Explore which demographic data may predict the PMP S-E score
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Sylvia Caballero
Study officials:
affiliation: Gregorio Marañón Hospital
name: Sylvia Caballero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnes CR, Adamson-Macedo EN. Perceived Maternal Parenting Self-Efficacy (PMP S-E) tool: development and validation with mothers of hospitalized preterm neonates. J Adv Nurs. 2007 Dec;60(5):550-60. doi: 10.1111/j.1365-2648.2007.04445.x.