Training Parenting Self-efficacy in Parents of Hospitalized Preterm Neonates

Parenting Clinical Trial

— CAP-PREM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02803866
• Other study ID #: CCF-Padres 01
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2016
• Last updated: June 14, 2016
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Hospital General Universitario Gregorio Marañon
• Contact: Sylvia Caballero, PhD
• Phone: 0034610670468
• Email: sylvia.caballero[@]salud.madrid.org
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Days

Eligibility

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 Design

Observational Model: Family-Based, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parenting
• Premature Birth
• Preterm Infants
• Training Support

Intervention

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

Locations

Country	Name	City	State
Spain	Sylvia Caballero	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceive parental self-efficacy before and after CAP-PREM program	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	No
Secondary	Influence of parents' psychological state in acquiring self-efficacy	The emotional situation of parents during their preterm neonate hospitalization may interfere with their perceived parenting sel-efficacy	4 weeks	No
Secondary	Explore which demographic data may predict the PMP S-E score	Gestational age, weeks of gestation,parity, first time of kangaroo care,	4 weeks	No