Programa PUEDES Infancia (PUEDES)

October 4, 2018 updated by: Cayetana Ruiz Zaldibar, University of Navarra

Programa Padres y Madres Unidos Educando en Estilos de Vida Saludables

The purpose of this study was to evaluate whether an intervention directed at promoting parental self-efficacy and skills, based on a positive parenting framework, improves parental competences and healthy practices in families with children aged 2 to 5 years old.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study has designed implemented and evaluated an intervention to promote parental competence and healthy practices in families with children aged 2 to 5 years old, addressing parental self-efficacy an skills. This research followed the first three stages of the Medical Research Council framework for complex interventions: the theoretical, modeling and exploratory trial phases. A randomized control trial with parents of children better 2 to 5 years old was conducted. The program consisted of two hour long four sessions. Parents were grouped in small groups (7-8 participants) and guided by a facilitator whose role was to provide a participative and trusting atmosphere to share opinions and experience in healthy lifestyles and parenting. Data collection was performed at three time points (pre-intervention, post-intervention and follow-up) to asses the preliminary efficacy, acceptability and feasibility of the program.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Universidad de Navarra

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be father or mother of at list one child between 2 to 5 years old
  • Be over 18 years old
  • Sign the informed consent

Exclusion Criteria:

  • Fathers or mothers that could have special necessities that could prevent the course of the sessions
  • Participants the could understand or speak spanish

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Participated in one introductory session, in the four sessions of PUEDES program during four weeks and in a closing session.
Behavioral: Intervention Group
PUEDES program included eight hours in groups and activities to practice at home.
Other Names:
  • PUEDES program group
No Intervention: Control Group
Participated in one introductory session and in a closing session.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline Parental Self-efficacy at post-intervention and three months. Tool to Measure Parental Self-efficacy (TOPSE) is a questionnaire developed to measure parental self-efficacy.
Time Frame: baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
Parenting self-efficacy (PSE) describes a parent's belief in their ability to perform the parenting role successfully. Tool to Measure Parental Self-efficacy (TOPSE) is specifically useful for the evaluation of parenting programs. TOPSE has 8 subscales about emotion and affection, play and enjoyment, empathy and understanding, control, discipline and boundaries, external pressures on parenting, acceptance of oneself and learning and knowledge.Regarding the validity and reliability of the scale varies between 0.80 and 0.89 per item, and of 0.94 as a whole (Kendall and Bloomfield, 2005).
baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
Change from baseline Parenting styles at post-intervention and three months. Parenting styles scale is a validated tool to measure the different types of parenting styles (democratic, authoritative, permissive or negligent).
Time Frame: baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
Parenting styles are the differences strategies that parents use in their child rearing. Parenting style scale called Escala de Evaluación de Estilos Educativos (4E), measures the different types of parenting styles (democratic, authoritative, permissive or negligent).It evaluates, through 20 items on a Likert scale the posture of parents in the traditional dimensions of educational styles: affection and communication, demands and control.The reliability coefficient of Cronbach's alpha of the scale is 0.73 (Sánchez-Sandoval, León and Román, 2012).
baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
Change from baseline Parenting Practice in health promotion at post-intervention and three months. Meals in our household is a parent-report questionnaire that measures six domains related to the families' mealtimes.
Time Frame: baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
They are difference practices that parents practice in there daily life that could promote healthy habits in their families.Questionnaire Meals in our household will be used to assess structure of family meals, problematic child mealtime behaviours, use of food as reward, parental concern about child diet, spousal stress related to child's mealtime behaviour, influence of child's food preferences on what other family members eat. The reliability coefficient of Cronbach's alpha is 0.77 (Anderson et al. 2012).
baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
Change from baseline Parenting Practice in health promotion at post-intervention and three months. Comprehensive Feeding Practice is a questionnaire focused on parents practice related to meals.
Time Frame: baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
Comprehensive Feeding Practice Questionnaire is reported by parents and assess the children involvement in meal planning and preparation and parental role model focused on if parents actively demonstrate healthy eating for the child.
baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parental satisfaction with the program. Questionnaire developed by researchers.
Time Frame: Post-intervention (5 weeks).
Parents from the intervention group will be asked about their parental satisfaction with the program. Their opinion about its need, and whether they will be able to recommend it to friends or family, using a Likert scale of 0 to 10 developed by researchers, where 0 is nothing and 10 is completely, also were questions of this questionnaire.
Post-intervention (5 weeks).
Positive parenting program evaluation. The Evaluation system of positive parenting programs is a scale developed to assess positive parenting programs.
Time Frame: Post-intervention (5 weeks).
The Evaluation system of positive parenting programs was designed to evaluate the interventions in positive parenting in Spain (Manzano et al., 2012). It is a tool that professional could use in the implementation, methodology and content of the program. The system has 17 indicators that refer to different aspects of intervention programs such as general assessment, objectives, materials, evaluation or ethical aspects. The results will be collected in a table that will show the scores of all the indicators, the total score of each thematic block and the final score obtained in the instrument. In this way it will be observed what parts of the program have more power and which should be improved.
Post-intervention (5 weeks).

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Navarra

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 17, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017.025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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