ParentingBienestarNCT06450496
On-line Evidence-based Positive Parenting Program for Families With Adolescents Exhibiting Mental Health Problems
A study testing Positive parenting on-line program in people with Parenting and Wellbeing, run by Lucia Jimenez at 1 site in Spain.
Trial summary
This project proposes the design, implementation, and evaluation of an online psycho-educational intervention program for families of adolescents with mental health problems. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Positive parenting on-line program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2024to Jan 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Seville
Seville, 41018
Lucía Antolín-Suárez, PhD
Lucía Antolín-Suárez
About this study
Official title: 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.
Read the 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.
- Being tested
- Positive parenting on-line program
- Keywords
- Effectiveness, Positive Parenting, Families, Adolescents, Mental Health, On-line Intervention, Evidence-based program, Random-control trial
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive parenting on-line programBehavioural
Positive parenting on-line program focused on parenting and personal competences relevant for parents with adolescents exhibiting mental health problems
| Study group | Role | What they receive |
|---|---|---|
| Bienestar Program | Experimental | On-line positive parenting program Receives: Behavioral: Positive parenting on-line program |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived parental role
Me as a Parent (Hamilton et al., 2015, translation Montesdeoca, 2019)
Measured: 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)
Measured: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Secondary outcomes (12)
Adolescent adjustment
The Kidscreen Questionnaire (European Kidscreen Group, 2006)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.)
Measured: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lucia Jimenez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucia Jimenez, University of Seville
- Investigators
- Lucía Antolín-Suárez, PhD, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450496
- Sponsor's protocol ID
- PID2020-117363RA-I00
- Acronym
- Bienestar
- Status last verified
- Jun 2024
- First submitted
- 13 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an On-line Evidence-based Positive Parenting Program for Families With Adolescents Exhibiting Mental Health Problems (Bienestar)
- ClinicalTrials.gov ID
- NCT06450496
- Acronym / sponsor ID
- Bienestar / PID2020-117363RA-I00
- Keywords
- Effectiveness, Positive Parenting, Families, Adolescents, Mental Health, On-line Intervention, Evidence-based program, Random-control trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Lucia JimenezUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project proposes the design, implementation, and evaluation of an online psycho-educational intervention program for families of adolescents with mental health problems.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bienestar Program | Experimental | Behavioral: Positive parenting on-line programOn-line positive parenting program |
| Control | No intervention | –Control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Do not have an A2 Spanish language level.
- Show signs of addiction to toxic substances.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive parenting on-line programPositive parenting on-line program focused on parenting and personal competences relevant for parents with adolescents exhibiting mental health problems | Behavioural | Bienestar Program |
Primary outcome
Perceived parental role
Time frame: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Me as a Parent (Hamilton et al., 2015, translation Montesdeoca, 2019)
Parental adjustment
Time frame: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Global Health Questionnaire (Goldberg \& Williams, 1988)
12 secondary outcomes
Adolescent adjustment
Time frame: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Adolescent adjustment
Time frame: 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
Time frame: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Parenting styles
Time frame: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Parenting styles
Time frame: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Parental psychological control
Time frame: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Parental Stress
Time frame: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Mindfulness in parenting
Time frame: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Psychological flexibility
Time frame: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Parental psychological flexibility
Time frame: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Basic Psychological Needs
Time frame: 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
Time frame: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Parenting
Active, not recruiting
Chicago Parent Program for Foster and Kinship Caregivers
Behavior Problem, Parenting
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Recruiting
Online Feeding Education for Fathers of Children With Feeding Problems
Feeding Problems, Parent Training
Recruiting
Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
Active, not recruiting
CHOICES3: Sickle Cell Disease Parenting CHOICES
Sickle Cell Disease, Sickle Cell Trait
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucía Antolín-Suárez, PhD principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive parenting on-line program in people with Parenting and Wellbeing, run by Lucia Jimenez 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 0 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucía Antolín-Suárez, PhD (+34954557720, luciaantolin@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived parental role (time frame: At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2024.