ParentingCAP-PREMNCT02803866
Training Parenting Self-efficacy in Parents of Hospitalized Preterm Neonates
An observational study of Parenting and Preterm Infants, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 10 to 15 days
- Conditions the study is for
- Parenting, Preterm Infants, Training Support
- What is being tested?
- Training program CAP-PREM
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Dec 2016
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 days
- All sexes
- No healthy volunteers
- Child
Study population: Parents of hospitalized preterm neonates
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Sylvia Caballero
Madrid, Madrid, 28007
Sylvia Caballero, PhD, 0034610670468, sylvia.caballero@salud.madrid.org
About this study
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
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.
Read the 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
- Conditions
- Parenting, Preterm Infants, Training Support
- Being tested
- Training program CAP-PREM
- Keywords
- Parenting Self-efficacy, Parent training program, Perceived self-efficacy tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training program CAP-PREMBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Training program CAP-PREM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (2)
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
Measured: 4 weeks
Explore which demographic data may predict the PMP S-E score
Gestational age, weeks of gestation,parity, first time of kangaroo care,
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon
- Investigators
- Sylvia Caballero, PhD, Principal investigator, Gregorio Marañón Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803866
- Sponsor's protocol ID
- CCF-Padres 01
- Acronym
- CAP-PREM
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 17973719
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02803866
- Acronym / sponsor ID
- CAP-PREM / CCF-Padres 01
- Conditions
- Parenting, Preterm Infants, Training Support
- Keywords
- Parenting Self-efficacy, Parent training program, Perceived self-efficacy tool
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents of preterm newborns (25-32 weeks of gestation) | – | Behavioral: Training program CAP-PREMParents (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 |
Who may qualify
- Ages
- 10 to 15 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Parents of hospitalized preterm neonates
Key inclusion criteria (6 listed)
- 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 .
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training program CAP-PREM1ºAfter 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 | Behavioural | Parents of preterm newborns (25-32 weeks of gestation) |
Primary outcome
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
2 secondary outcomes
Influence of parents' psychological state in acquiring self-efficacy
Time frame: 4 weeks
Explore which demographic data may predict the PMP S-E score
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Background: PubMed 17973719Barnes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia Caballero, PhD principal investigator
Gregorio Marañón Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parenting and Preterm Infants, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvia Caballero, PhD (0034610670468, sylvia.caballero@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceive parental self-efficacy before and after CAP-PREM program (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02803866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.