Programa PUEDES Infancia

Parenting Clinical Trial

— PUEDES  

Official title:

Programa Padres y Madres Unidos Educando en Estilos de Vida Saludables

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698110
• Other study ID #: 2017.025
• Status: Completed
• Phase: N/A
• Start date: March 30, 2017
• Est. completion date: November 17, 2017

Study information

• Verified date: October 2018
• Source: University of Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 17, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Life Style
• Parenting
• Self Efficacy

Intervention

Behavioral:
• Intervention Group
PUEDES program included eight hours in groups and activities to practice at home.

Locations

Country	Name	City	State
Spain	Universidad de Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
University of Navarra

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

Kendall S, Bloomfield L. Developing and validating a tool to measure parenting self-efficacy. J Adv Nurs. 2005 Jul;51(2):174-81. — View Citation

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. Epub 2007 May 28. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
Primary	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).	baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
Primary	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).	baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
Primary	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.	baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
Secondary	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.	Post-intervention (5 weeks).
Secondary	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.	Post-intervention (5 weeks).