NCT03698110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2017

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

November 17, 2017

Last Update Submit

October 4, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (2)

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

    Post-intervention (5 weeks).

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

    Post-intervention (5 weeks).

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participated in one introductory session, in the four sessions of PUEDES program during four weeks and in a closing session.

Behavioral: Intervention Group

Control Group

NO INTERVENTION

Participated in one introductory session and in a closing session.

Interventions

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

Also known as: PUEDES program group
Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (4)

  • 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.

    PMID: 15963189BACKGROUND
  • Sánchez-Sandoval Y, León E, Román M. Adaptación familiar de niños y niñas adoptados internacionalmente. Anales de psicología 28(2): 558-566, 2012

    BACKGROUND
  • 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.

    PMID: 22741169BACKGROUND
  • 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.

    PMID: 17535817BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD in Nursing Student

Study Record Dates

First Submitted

November 17, 2017

First Posted

October 5, 2018

Study Start

March 30, 2017

Primary Completion

June 1, 2017

Study Completion

November 17, 2017

Last Updated

October 5, 2018

Record last verified: 2018-10

Locations