Training Parenting Self-efficacy in Parents of Hospitalized Preterm Neonates

NCT ID: NCT02803866

Last Updated: 2016-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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

Conditions

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Parenting Preterm Infants Training Support

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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Parents of preterm newborns (25-32 weeks of gestation)

Parents (mother or mother+father) of preterm newborns admitted at the Gregorio Marañón Hospital from birth, recruited during the first 10 days of preterm newborn hospitalization and receiving the training program CAP-PREM

Training program CAP-PREM

Intervention Type BEHAVIORAL

1ºAfter recruitment parents will fill the PMP S-E tool and the psychological tests evaluating their stress and depression . 2º parents will receive the training program during 4 weeks. 3º: before hospital discharge parents will fill again the PMP S-E tool and the psychological test evaluating their depression and anxiety

Interventions

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Training program CAP-PREM

1ºAfter recruitment parents will fill the PMP S-E tool and the psychological tests evaluating their stress and depression . 2º parents will receive the training program during 4 weeks. 3º: before hospital discharge parents will fill again the PMP S-E tool and the psychological test evaluating their depression and anxiety

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Days

Maximum Eligible Age

15 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role lead

Responsible Party

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Manuel Sanchez Luna

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sylvia Caballero, PhD

Role: PRINCIPAL_INVESTIGATOR

Gregorio Marañón Hospital

Locations

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Sylvia Caballero

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Sylvia Caballero, PhD

Role: CONTACT

0034610670468

Sylvia Caballero, PhD

Role: CONTACT

00034915290018 ext. 70018

Facility Contacts

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Sylvia Caballero, PhD

Role: primary

0034610670468

References

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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.

Reference Type BACKGROUND
PMID: 17973719 (View on PubMed)

Other Identifiers

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CCF-Padres 01

Identifier Type: -

Identifier Source: org_study_id

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