NCT07766746

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Aug 2026

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

Study Progress11%
Aug 2026Dec 2026

First Submitted

Initial submission to the registry

July 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

July 15, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

Parenting SkillsParental Self-EfficacyDigital Mental HealthPilot StudyUsabilityChild and Adolescent Mental Health

Outcome Measures

Primary Outcomes (1)

  • Parenting to Reduce Adolescent Depression and Anxiety Scale Total Score

    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.

    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)

Secondary Outcomes (2)

  • 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)

Other Outcomes (4)

  • Post-Study System Usability Questionnaire

    4 weeks, directly after intervention (intervention group) 8 weeks, directly after intervention (waitlist control group)

  • Qualitative data from participants' interviews

    4 weeks, directly after intervention (intervention group) 8 weeks, directly after intervention (waitlist control group)

  • Qualitative data from experts' focus group

    Once, within 3 months after completion of the quantitative data collection

  • +1 more other outcomes

Study Arms (2)

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.

Device: App YOUCA (prototype)

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).

Interventions

Youngsters Upbringing Mental Health Counseling App (YOUCA) to provide parents and caregivers with accessible professional guidance. YOUCA aims to strengthen parenting skills, to empower parents by helping them with strategies to support their children, particularly in times of emotional difficulty and provide the opportunity to seek professional help.

Immediate Intervention Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hochschule Campus Wien

Vienna, 1100, Austria

Location

Related Publications (4)

  • Lewis, J. R. (2002). Psychometric Evaluation of the PSSUQ Using Data from Five Years of Usability Studies. International Journal of Human-Computer Interaction, 14(3-4), 463-488. https://doi.org/10.1080/10447318.2002.9669130

    BACKGROUND
  • Hamilton, V.E., Matthews, J.M. & Crawford, S.B. Development and Preliminary Validation of a Parenting Self-Regulation Scale: "Me as a Parent". J Child Fam Stud 24, 2853-2864 (2015). https://doi.org/10.1007/s10826-014-0089-z

    BACKGROUND
  • Cardamone-Breen MC, Jorm AF, Lawrence KA, Mackinnon AJ, Yap MBH. The Parenting to Reduce Adolescent Depression and Anxiety Scale: Assessing parental concordance with parenting guidelines for the prevention of adolescent depression and anxiety disorders. PeerJ. 2017 Sep 18;5:e3825. doi: 10.7717/peerj.3825. eCollection 2017.

    PMID: 28951815BACKGROUND
  • Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.

    PMID: 19996233BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Carina Hauser

    Hochschule Campus Wien

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A mixed-methods randomized waitlist-controlled pilot trial will enroll 25 parents of children with mental health difficulties. Participants will be randomized at baseline (T0) to either an immediate-access intervention group or a waitlist control group. Outcomes will be assessed at three time points: baseline (T0), follow-up 1 (T1), and follow-up 2 (T2). Parenting skills and parental self-efficacy will be measured before and after the intervention period, while usability and satisfaction will be assessed following app use. To complement quantitative findings, a usage diary through the intervention period and optional post-intervention interviews will be conducted with at least 10 participants, and a focus group with five psychosocial experts will be held to obtain additional feedback on the app.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

July 15, 2026

First Posted

August 14, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

The coded data from the quantitative survey will be made freely available to other researchers via the Open Science Framework (OSF).

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
With the publication of the results (anticipated 2027) via the Open Science Framework (OSF)
Access Criteria
Unrestricted access to coded data underlying the scientific publication in a common file format (.csv)

Locations