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临床试验/NCT07766746
NCT07766746尚未招募不适用

Usability and Preliminary Efficacy of the Youngsters Upbringing Mental Health Information and Counselling App (YOUCA) for Parents of Children With Mental Health Issues: Study Protocol for a Mixed-Methods Randomized Waitlist-Controlled Pilot Trial

Hochschule Campus Wien (University of Applied Sciences Campus Vienna)1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
Parenting to Reduce Adolescent Depression and Anxiety Scale Total Score

研究概览

简要总结

Parents play an important role in supporting their children's mental health but often feel unsure how to respond to emotional or mental health difficulties. To address this need, the PsyGes project developed the Youngsters Upbringing Mental Health Information and Counselling App (YOUCA), a smartphone app that provides parents with information, practical guidance, daily tips, communication strategies, a mental health glossary, and a directory of support services.

This study aims to evaluate the usability and potential effectiveness of YOUCA in improving parenting skills and parental self-efficacy (confidence in supporting a child). In this mixed-methods randomized waitlist-controlled pilot study, approximately 25 parents of children with mental health difficulties will participate. Participants will use the app over a four-week period and complete questionnaires before and after use. App usability and satisfaction will also be assessed. Interviews with parents and a focus group with psychosocial experts will provide additional feedback to support further app development and future larger-scale evaluation.

详细描述

Parents play a key role in supporting their children's mental health and emotional well-being. However, many parents feel uncertain about how to respond when their child is experiencing emotional or mental health difficulties. They may struggle to communicate effectively, lack confidence in their parenting abilities, experience concerns about stigma, or have difficulty identifying appropriate support services. To address these challenges, the project PsyGes developed the Youngsters Upbringing Mental Health Information and Counselling App (YOUCA), a smartphone application designed to provide parents and caregivers with accessible information, practical guidance, and support.

The YOUCA app aims to strengthen parenting skills, increase parents' confidence in supporting their children, and improve awareness of available support services. The app includes tailored daily tips, strategies for communicating with children and maintaining positive parent-child relationships, a searchable glossary of mental health terms, and a directory of support services.

The purpose of this study is to evaluate the usability and potential efficacy of the YOUCA app. Specifically, the study will examine how parents perceive the app's usability and usefulness and whether using the app for four weeks may improve parenting skills and parental self-efficacy. Parental self-efficacy refers to a parent's confidence in their ability to support and guide their child. The researchers expect that regular use of the app will help parents feel more capable and better equipped to manage challenges related to their children's mental health.

This study is a mixed-methods randomized waitlist-controlled pilot trial. Approximately 25 parents or caregivers of children with mental health difficulties will be recruited, with at least 20 participants expected to complete the study. Participants will be randomly assigned either to receive immediate access to the app or to a waitlist group that will receive access later. This allows researchers to compare outcomes between participants who have used the app and those who have not yet used it.

The study will take place over eight weeks and include three assessment points: before app use begins, after the first study period, and after the second study period. Participants will complete questionnaires measuring parenting skills and parental self-efficacy before and after using the app. The usability of and satisfaction with the app will also be assessed after app use. Additionally, participants are required to maintain a usage diary to document their interactions and experiences with the app during app use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (psychological) parents (Age > 18 years) of children/adolescents aged 10-17
  • AND previously/currently concerned about their child's mental health & therefore seeking information/support
  • AND willingness to comply with all study related procedures and provide informed consent
  • AND owning a smartphone and willing to use it for installing and testing the YOUCA App within the intervention phase
  • AND situated in the City of Vienna or surrounding areas

排除标准

  • Lack of consent capacity in parents or acute crisis of the participants. No external expert assessment is conducted. An acute crisis is defined as screened by PHQ-4 score rated from 9 to 12 (Kroenke et al. 2009).
  • Insufficient knowledge of German for questionnaire completion, app use and participation in the interview
  • Inclusion Criteria for Experts in Focus Group
  • Active work in the field of psychosocial and mental health in the last three years
  • AND working with children / adolescents between age 10 - 17 in the field of psychosocial and mental health
  • AND willing to test the app on a private smartphone
  • AND at least one year of work experience in respective fields
  • AND situated in the City of Vienna or surrounding areas

研究组 & 干预措施

Immediate Intervention Group

Experimental

Before using the app, participants will receive an initial at-home onboarding session to familiarize them with the application. Following this introduction, they are instructed to use the app independently for a duration of four weeks. During this period, participants are asked to use the app three to four times a week.

干预措施: App YOUCA (prototype) (Device)

Waitlist Control Group

No Intervention

Participants randomized to the waitlist control arm will not have access to the YOUCA app during the initial intervention period. They will complete study assessments at baseline (T0) and follow-up 1 (T1) at the same time points as participants in the intervention arm. Following completion of the waiting period, participants will receive access to the YOUCA app and complete a post-intervention follow-up assessment (T2).

结局指标

主要结局

Parenting to Reduce Adolescent Depression and Anxiety Scale Total Score

时间窗: Baseline (intervention group and waitlist control group) 4 weeks, directly after intervention (intervention group) 4 weeks, directly after waiting time (waitlist control group) 8 weeks, directly after intervention (waitlist control group)

The Parenting to Reduce Adolescent Depression and Anxiety Scale Scale: Mostly 4-point Likert scales across 79 items, assessing either the frequency of a behavior (Never to Often) or the likelihood of a reaction in hypothetical scenarios (Very unlikely to Very likely). Calculation/Assessment: Criterion-referenced scoring. Responses are dichotomized based on clinical guidelines: * 1 point: Concordant with guidelines. * 0 points: Non-concordant with guidelines. * Points are summed up to calculate the total or subscale scores. Unit of measurement: Points (0-79). A higher score indicates greater adherence to preventive parenting guidelines.

次要结局

  • Parenting to Reduce Adolescent Depression and Anxiety Scale Subscales(Baseline (intervention group and waitlist control group) 4 weeks, directly after intervention (intervention group) 4 weeks, directly after waiting time (waitlist control group) 8 weeks, directly after intervention (waitlist control group))
  • Me as a Parent Scale(Baseline (intervention group and waitlist control group) 4 weeks, directly after intervention (intervention group) 4 weeks, directly after waiting time (waitlist control group) 8 weeks, directly after intervention (waitlist control group))

研究者

发起方
Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carina Hauser

Senior Researcher

Hochschule Campus Wien (University of Applied Sciences Campus Vienna)

研究点 (1)

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