Training Parenting Self-efficacy in Parents of Hospitalized Preterm Neonates (CAP-PREM)

June 14, 2016 updated by: Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon

Assessing Parenting Self-efficacy Before and After Applying a Specific Training Program for Parents (CAP-PREM: Preterm Capacitation) During Hospitalization of Preterm Neonates

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 2 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parents of hospitalized preterm neonates

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceive parental self-efficacy before and after CAP-PREM program
Time Frame: 4 weeks
Training parents for caring their preterm newborn from the first days of hospitalization will give them the opportunity to be active parents and improve their perceive parenting
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of parents' psychological state in acquiring self-efficacy
Time Frame: 4 weeks
The emotional situation of parents during their preterm neonate hospitalization may interfere with their perceived parenting sel-efficacy
4 weeks
Explore which demographic data may predict the PMP S-E score
Time Frame: 4 weeks
Gestational age, weeks of gestation,parity, first time of kangaroo care,
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Gregorio Marañon

Investigators

  • Principal Investigator: Sylvia Caballero, PhD, Gregorio Marañón Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ANTICIPATED)

July 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (ESTIMATE)

June 17, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCF-Padres 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preterm Infants

Clinical Trials on Training program CAP-PREM

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe