NCT06450496

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 13, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

May 13, 2024

Last Update Submit

June 3, 2024

Conditions

ParentingWellbeing

Keywords

EffectivenessPositive ParentingFamiliesAdolescentsMental HealthOn-line InterventionEvidence-based programRandom-control trial

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Adolescent adjustment

    At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up

  • Adolescent adjustment

    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

    At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up

  • Parenting styles

    At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up

  • Parenting styles

    At pretest, at posttest at the completion of the program (up to 2 months) and 4-to-6 months follow-up

  • +7 more secondary outcomes

Other Outcomes (5)

  • Perception of usefulness of the program

    At posttest atthe completion of the program (up to 2 months)

  • Satisfaction with the program

    At posttest atthe completion of the program (up to 2 months)

  • Assessment of program components

    At posttest atthe completion of the program (up to 2 months)

  • +2 more other outcomes

Study Arms (2)

Bienestar Program

EXPERIMENTAL

On-line positive parenting program

Behavioral: Positive parenting on-line program

Control

NO INTERVENTION

Control group

Interventions

Positive parenting on-line programBEHAVIORAL

Positive parenting on-line program focused on parenting and personal competences relevant for parents with adolescents exhibiting mental health problems

Bienestar Program

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Seville

Seville, 41018, Spain

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Lucía Antolín-Suárez, PhD

    University of Seville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucía Antolín-Suárez, PhD

CONTACT

+34954557720luciaantolin@us.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 13, 2024

First Posted

June 10, 2024

Study Start

June 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

June 10, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

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.

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

Locations

ES(1)