Clinical trial NCT03698110: Programa PUEDES Infancia
Official title: Programa Padres y Madres Unidos Educando en Estilos de Vida Saludables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Self Efficacy
Life Style
Lead sponsor: University of Navarra
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
measure: 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).
timeFrame: baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
measure: 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.
timeFrame: baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
measure: 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.
timeFrame: baseline (before starting the program), post-intervention (5 weeks) and follow-up (3 months after the end of the program)
Secondary outcomes:
measure: Parental satisfaction with the program. Questionnaire developed by researchers.
timeFrame: Post-intervention (5 weeks).
measure: Positive parenting program evaluation. The Evaluation system of positive parenting programs is a scale developed to assess positive parenting programs.
timeFrame: Post-intervention (5 weeks).
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Universidad de Navarra
state: Navarra
Study officials:
References:
citation: 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.
citation: Sánchez-Sandoval Y, León E, Román M. Adaptación familiar de niños y niñas adoptados internacionalmente. Anales de psicología 28(2): 558-566, 2012
citation: 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.
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. doi: 10.1093/jpepsy/jsm037. Epub 2007 May 28.