On-line Evidence-based Positive Parenting Program for Families With Adolescents Exhibiting Mental Health Problems (Bienestar)

Development of an On-line Evidence-based Positive Parenting Program for Families With Adolescents Exhibiting Mental Health Problems (Bienestar)

This project proposes the design, implementation, and evaluation of an online psycho-educational intervention program for families of adolescents with mental health problems.

Study Overview

• Status: Not yet recruiting
• Conditions: Wellbeing; Parenting
• Intervention / Treatment: Behavioral: Positive parenting on-line program

Detailed Description

Mental health problems in the child and adolescent population constitute a major challenge for society, not only because of their high prevalence but also because they undermine opportunities for the healthy development of young people, negatively impacting the wellbeing and progress of societies. Furthermore, these problems have important consequences on families of adolescents, who experience an increase in support needs, requiring effective and quality resources that allow them to adequately face the difficulties, while at the same time optimizing their parental skills to promote the development of their offspring.

Although nowadays there are more and more institutions that understand formal support to families as a social responsibility and that relies on psychoeducational programs to promote positive parenting as a beneficial strategy, the truth is that available resources aimed at covering the specific needs presented by families with adolescents with mental health problems are still scarce. Moreover, the recent emergence of the Covid-19 pandemic has resulted in even fewer evidence-based programs that are adapted to this new reality. A reality that imposes strict measures of social distance, and which generates new needs and difficulties for all families and, especially, for those who were previously in a situation of vulnerability.

In line with these approaches, and grounded in the conviction of the need to carry out applied research that is capable of transferring to society solutions derived from science and innovation, this project proposes the design, implementation, and evaluation of an online psycho-educational intervention program for families of adolescents with mental health problems.

The project presented, in line with the Spanish Law 14/2011 of 1 June on Science, Technology, and Innovation, is based on the recognition that tasks of generation, dissemination, and transference of scientific knowledge are inherent to research, as well as on the premise that the results derived from publicly funded projects should be transferred to society, contributing to the progress of citizens and meeting social challenges. In accordance with these considerations, this project aims to contribute to improving the quality of life of the families of adolescents with mental health problems by recognizing and meeting their needs, as well as optimizing parental and family skills. The achievement of this goal will involve obtaining evidence derived from empirical research that will return to society through the development and provision of an empirically validated psychoeducational intervention program aimed at promoting positive parenting in families of adolescents with mental health problems.

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucía Antolín-Suárez, PhD; Phone Number: +34954557720; Email: luciaantolin@us.es

Study Locations

• Spain
  • Seville, Spain, 41018
    • University of Seville
    • Contact: Lucía Antolín-Suárez, PhD
    • Principal Investigator: Lucía Antolín-Suárez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

The participants will be the caregivers (mothers or fathers) of adolescents with mental health problems of Spain. The caregiver and the target adolescent will act as respondents.

For the caregivers, the inclusion criteria are:

• Relationship with the identified patient (adolescent): Mother or father who fulfils the role of caregiver.
• They have some computer support (PC, tablet, mobile phone...) with which to carry out the program.
• Time availability to participate in the evaluation sessions.
• Motivation to participate in the program.

For the adolescents, the inclusion criteria are:

• Age between 10 and 19 years old.
• Experiencing any mental health problem.

All the inclusion criteria are requested to participate in the study.

Exclusion criteria:

Caregivers:

• Do not have an A2 Spanish language level.
• Show signs of addiction to toxic substances.

Target adolescents:

• Age less than 10 years or more than 19 years.
• Do not have an A2 Spanish language leve.

Any exclusion criteria will be considering for exclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control group
Experimental: Bienestar Program; On-line positive parenting program	Behavioral: Positive parenting on-line program; Positive parenting on-line program focused on parenting and personal competences relevant for parents with adolescents exhibiting mental health problems

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived parental role	Me as a Parent (Hamilton et al., 2015, translation Montesdeoca, 2019)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Parental adjustment	Global Health Questionnaire (Goldberg & Williams, 1988)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adolescent adjustment	The Kidscreen Questionnaire (European Kidscreen Group, 2006)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Adolescent adjustment	Strengths and Difficulties Questionnaire (Goodman, 2001; 2022)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Satisfaction with the adolescent's life	Satisfaction with Life Scale (Diener et al., 1985, validation Atienza et al., 2000)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Parenting styles	Parenting Styles and Dimensions Questionnaire (Robinson et al., 2001)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Parenting styles	Parenting Scale (Arnold et al., 1993)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Parental psychological control	Psychological Control Scale questionnaire (Barber et al., 1996)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Parental Stress	Parental Stress Scale (Berry & Jones; 1995, validation Oronoz et al., 2007)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Mindfulness in parenting	The Interpersonal Mindfulness in Parenting scale (Duncan, 2023; validation Martínez et al. 2023)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Psychological flexibility	Acceptance and Action Questionnaire-II (Bond et al., 2011; validation Ruiz et al., 2013)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Parental psychological flexibility	Parental Acceptance Questionnaire (Greene et al., 2015; validation Flujas-Contreras et al., 2020)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Basic Psychological Needs	Basic Psychological Need Satisfaction and Frustration Scale (Chen et al., 2015; translation Rodríguez-Meirinhos et al., 2020)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Proactive management of basic psychological needs	Need crafting questionnaire (Laporte et al., 2021; validation team, s.f.)	At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of usefulness of the program	Helpful Aspects of Therapy questionnaire adapted (Khor et al., 2021; Llewelyn et al., 1988; O'Halloran et al., 2016)	At posttest atthe completion of the program (up to 2 months)
Satisfaction with the program	Client Satisfaction Questionnaire (Larsen et al.,1979); validation Roberts & Attkisson, 1983)	At posttest atthe completion of the program (up to 2 months)
Assessment of program components	Parenting Online Satisfaction adapted (Suárez et al., 2018)	At posttest atthe completion of the program (up to 2 months)
Usability	System Usability Scale (Brooke, 1996; validation Hedlefs & Villegas, 2016)	At posttest atthe completion of the program (up to 2 months)
Usability	User Experience Questionnaire-S (Schrepp et al., 2017)	At posttest atthe completion of the program (up to 2 months)

Collaborators and Investigators

• Sponsor: Lucia Jimenez
• Investigators: Principal Investigator: Lucía Antolín-Suárez, PhD, University of Seville

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Mental Health; Effectiveness; Families; Positive Parenting; On-line Intervention; Evidence-based program; Random-control trial
• Other Study ID Numbers: PID2020-117363RA-I00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The datasets generated during and/or analysed during the current study not constrained by privacy or confidentiality restrictions will be stored in the publicly available repository of the University of Seville, IdUs: https://idus.us.es/.

Further requirements by the funder of the project as well as open-access based journals will be considered.

• IPD Sharing Time Frame: Intention to publish: 31/08/2026
• IPD Sharing Access Criteria: Publicly available repository of the University of Seville, IdUs: https://idus.us.es/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No