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ParentingPUEDESNCT03698110

Programa PUEDES Infancia

A study testing Intervention Group in people with Parenting and Self Efficacy, run by University of Navarra at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Parenting, Self Efficacy, Life Style
What is being tested?
Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteSpain
Study dates
30 Mar 2017to 17 Nov 2017
Phase
Interventional
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Intervention Group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention GroupBehavioural

    Also called PUEDES program group

    PUEDES program included eight hours in groups and activities to practice at home.

Study groups in NCT03698110
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipated in one introductory session, in the four sessions of PUEDES program during four weeks and in a closing session.
Receives: Behavioral: Intervention Group
Control GroupNo interventionParticipated in one introductory session and in a closing session.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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).

    Measured: baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)

  2. 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).

    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).

    Measured: baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)

  3. 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.

    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).

    Measured: baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)

  4. 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.

    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.

    Measured: baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)

Secondary outcomes (2)

  1. Parental satisfaction with the program. Questionnaire developed by researchers.

    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.

    Measured: Post-intervention (5 weeks).

  2. Positive parenting program evaluation. The Evaluation system of positive parenting programs is a scale developed to assess positive parenting programs.

    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.

    Measured: Post-intervention (5 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2018
  2. Study start30 Mar 2017
  3. Primary completion1 Jun 2017
  4. Study completion17 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03698110
Sponsor's protocol ID
2017.025
Acronym
PUEDES
Status last verified
Oct 2018
First submitted
17 Nov 2017
Last updated
5 Oct 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kendall S, Bloomfield L. Developing and validating a tool to measure parenting self-efficacy. J Adv Nurs. 2005 Jul;51(2):174-81. doi: 10.1111/j.1365-2648.2005.03479.x.

    PubMed 15963189

  • Sánchez-Sandoval Y, León E, Román M. Adaptación familiar de niños y niñas adoptados internacionalmente. Anales de psicología 28(2): 558-566, 2012

  • Anderson SE, Must A, Curtin C, Bandini LG. Meals in Our Household: reliability and initial validation of a questionnaire to assess child mealtime behaviors and family mealtime environments. J Acad Nutr Diet. 2012 Feb;112(2):276-84. doi: 10.1016/j.jada.2011.08.035.

    PubMed 22741169

  • Musher-Eizenman D, Holub S. Comprehensive Feeding Practices Questionnaire: validation of a new measure of parental feeding practices. J Pediatr Psychol. 2007 Sep;32(8):960-72. doi: 10.1093/jpepsy/jsm037. Epub 2007 May 28.

    PubMed 17535817

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Group in people with Parenting and Self Efficacy, run by University of Navarra 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Oct 2018. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. 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 NCT03698110, which also lists 4 linked publications.

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 5 Oct 2018.

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