NCT06865573

Brief Summary

The goal of this longitudinal mixed-methods study is to investigate caregiver strain, family processes and health outcomes after youth psychiatric inpatient treatment. Caregivers of youth who received inpatient treatment for mental health problems will complete a survey at three timepoints (baseline, 3- and 6- month followup) reporting on youth outcomes, caregiver well-being, and family processes. Qualitative interviews on caregivers' challenges, needs, and resources around the return to home care are conducted with a subsample (target n = 10) of participants. The main research questions (RQs) are: RQ 1: Do family processes contribute to youth mental health outcomes after discharge from inpatient treatment? RQ 1a: What family-level risk factors predict youth readmission to inpatient treatment? RQ 1b: Do family processes predict youth mental health trajectories over time? RQ 2: Is there a reciprocal relationship between youth mental health problems and caregiver burden? RQ 2a: Do family processes mediate the association between caregiver burden and youth mental health problems? RQ 3: How do caregivers experience their children's return to home care? RQ 3a: What challenges and needs do caregivers report? RQ 3b: What types of follow-up services do families receive and/or have access to? RQ 3c: How do caregivers cope with ongoing difficulties in the post-discharge period?

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

March 5, 2025

Last Update Submit

March 12, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Inpatient readmission

    Occurrence (and admission date) of inpatient mental health treatment after discharge

    Within 6 months

  • Youth mental health

    Caregiver-reported youth internalizing and externalizing problems (assessed using the Pediatric Symptom Checklist)

    Change from baseline (T0) to 3-month (T1) and 6-month (T2) follow-up

Secondary Outcomes (1)

  • Youth health-related quality of life

    Change from baseline (T0) to 3-month (T1) and 6-month (T2) follow-up

Study Arms (1)

caregivers

primary caregivers of youth who received inpatient psychiatric treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary caregivers (parents or guardians regardless of the biological relationship to the child) of children and adolescents who received inpatient psychiatric treatment

You may qualify if:

  • years or older
  • primary caregiver of a child or adolescent aged 7-21 years of any gender who received inpatient treatment in a psychiatric institution in Germany, Austria, or Switzerland (min. 24 h stay) within the past month (regardless of the diagnosis or the reason for the treatment, respectively)
  • lived with the child or adolescent in the same household since discharge

You may not qualify if:

  • another caregiver of the same child has already participated in the study
  • insufficient knowledge of German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Martina Zemp, Professor

    University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amos-Silvio E Friedrich

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 10, 2025

Study Start

May 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

March 17, 2025

Record last verified: 2025-03