DigiPuR: Digitally Supported Psychotherapy and Reintegration

NCT04986228 | Completed

• 1 other identifier: 53-5400.1-005/09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study "DigiPuR" (Digitally Supported Psychotherapy and Reintegration) examines the effectiveness of a new, digital aftercare program for children and adolescents after a psychiatric hospitalization in the intervention group compared to regular aftercare in the control group. Thereby, the randomized controlled trial with a naturalistic parallel group study design provides longitudinal data on the reintegration phase with a pre-post follow-up assessment and a daily ambulatory assessment from the point of view of patients, parents, and teachers. The aim of the new aftercare program is to facilitate reintegration after an inpatient hospital stay for children and adolescents as well as their attachment figures, to reduce readmissions and, if necessary, to ensure a good transition to outpatient structures. For this purpose, regular video calls without travel time between the children and adolescents as well as their attachment figures such as parents and teachers and, if necessary, external support systems are conducted with the clinic. Beyond these appointments, a smartphone-based secure messenger will allow all participants to communicate directly with the therapist. It is expected that the aftercare program in the intervention group will lead to improvements in health-related quality of life and treatment satisfaction, as well as reduce symptom severity and readmissions.

Conditions

Mental Disorder in Childhood

Keywords

Aftercare; E-Mental Health; Mental disorders; Triad; Adolescent; Child; Discharge; Readmission; Relapse prevention; Ambulatory assessment; Patient reported outcomes

Outcome Measures

Primary Outcomes (10)

• Change in symptom severity (patient report)

  Symptom severity as assessed by patients is measured using the Diagnostic System for Mental Disorders according to ICD-10 and DSM-5 for Children and Adolescents - III Screening questionnaire (DISYPS-III SCREEN; Döpfner \& Görtz-Dorten, 2017) at the time of admission and discharge of inpatient child and adolescent psychiatric treatment, and at 8, 24, and 37 weeks after discharge. Possible values range from 49 to 174 with higher scores indicating a worse outcome.

  Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)

• Change in symptom severity (parent report)

  Symptom severity as assessed by parents is measured using the Diagnostic System for Mental Disorders according to ICD-10 and DSM-5 for Children and Adolescents - III Screening questionnaire (DISYPS-III SCREEN; Döpfner \& Görtz-Dorten, 2017) at the time of admission and discharge of inpatient child and adolescent psychiatric treatment, and at 8, 24, and 37 weeks after discharge. Possible values range from 49 to 174 with higher scores indicating a worse outcome.

  Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)

• Change in symptom severity (teacher report)

  Symptom severity as assessed by teachers is measured using the Diagnostic System for Mental Disorders according to ICD-10 and DSM-5 for Children and Adolescents - III Screening questionnaire (DISYPS-III SCREEN; Döpfner \& Görtz-Dorten, 2017) at the time of admission and discharge of inpatient child and adolescent psychiatric treatment, and at 8, 24, and 37 weeks after discharge. Possible values range from 49 to 174 with higher scores indicating a worse outcome.

  Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)

• Change in Patients' Health-related quality of life

  Health-related quality of life as assessed by patients is measured using the Health Related Quality of Life Questionnaire for Children and Young People and their Parents (KIDSCREEN-27; KIDSCREEN Group Europe, 2006) at the time of admission and discharge of inpatient child and adolescent psychiatric treatment, and at 8, 24, and 37 weeks after discharge. Possible values range from 27 to 135 with higher scores indicating a better outcome.

  Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)

• Change in Parents' Health-related quality of life

  Health-related quality of life as assessed by parents is measured using the Health Related Quality of Life Questionnaire for Children and Young People and their Parents (KIDSCREEN-27; KIDSCREEN Group Europe, 2006) at the time of admission and discharge of inpatient child and adolescent psychiatric treatment, and at 8, 24, and 37 weeks after discharge. Possible values range from 27 to 135 with higher scores indicating a better outcome.

  Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)

• Patients' Satisfaction with treatment

  Satisfaction with treatment as assessed by patients is measured using questionnaire versions based on the Questionnaire for the assessment of treatment (FBB; Mattejat \& Remschmidt, 1999) at 8 weeks after discharge. Possible values range from 0 to 76 with higher scores indicating a better outcome.

  Post (8 weeks after discharge)

• Parents' Satisfaction with treatment

  Satisfaction with treatment as assessed by parents is measured using questionnaire versions based on the Questionnaire for the assessment of treatment (FBB; Mattejat \& Remschmidt, 1999) at 8 weeks after discharge. Possible values range from 0 to 84 with higher scores indicating a better outcome.

  Post (8 weeks after discharge)

• Therapists' Satisfaction with treatment

  Satisfaction with treatment as assessed by therapists is measured using questionnaire versions based on the Questionnaire for the assessment of treatment (FBB; Mattejat \& Remschmidt, 1999) at 8 weeks after discharge. Possible values range from 0 to 72 with higher scores indicating a better outcome.

  Post (8 weeks after discharge)

• Teachers' Satisfaction with treatment

  Satisfaction with treatment as assessed by teachers is measured using questionnaire versions based on the Questionnaire for the assessment of treatment (FBB; Mattejat \& Remschmidt, 1999) at 8 weeks after discharge. Possible values range from 0 to 56 with higher scores indicating a better outcome.

  Post (8 weeks after discharge)

• Difference and change in percentage of readmissions

  The percentage of readmissions is obtained by analyzing internal hospital controlling data. The change of these percentages over time is considered and compared across the study groups.

  Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)

Secondary Outcomes (17)

• Change in patients' Stress Vulnerability

  Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)

• Change in patients' Stress Coping Strategies

  Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)

• Change in patients' school related self-efficacy

  Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)

• Change in patients' social self-efficacy

  Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)

• Change in parents' social self-efficacy

  Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)

Other Outcomes (17)

• Change in well-being (patients' Ambulatory Assessment)

  Daily 2 weeks before discharge until 8 weeks after

• Change in affect (patients' Ambulatory Assessment)

  Daily 2 weeks before discharge until 8 weeks after

• Change in sleep quality (patients' Ambulatory Assessment)

  Daily 2 weeks before discharge until 8 weeks after

Study Arms (2)

Digital aftercare

EXPERIMENTAL

The group with the new digital aftercare is compared with the active control group with regular aftercare.

Other: Digital aftercare

Treatment-as-usual (TAU)

ACTIVE COMPARATOR

The group with regular aftercare (TAU) serves as an active control group.

Other: TAU

Interventions

Digital aftercare OTHER

The intervention group will receive a digital aftercare service, consisting of video calls and an app, for a period of up to eight weeks after discharge. These enable an uncomplicated and yet intensive exchange with the clinic from the comfort of the participants' own homes. To enable to optimally plan the treatment and assess its success, all participants complete questionnaires on multiple time points about different topics.

Digital aftercare

TAU OTHER

The control group will receive the regular follow-up consultations in the clinic (treatment-as-usual, TAU). This includes at least one consultation with the case-leading therapist from the previous inpatient stay about 6 weeks after discharge. The assessment consisting of questionnaires at multiple time points about different topics is the same as in the intervention group.

Treatment-as-usual (TAU)

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents who received partial or full inpatient treatment in the Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy at the University Hospital Tuebingen, Germany (diagnosis irrelevant) and a relevant primary attachment figure (parent or caregiver from a residential group)
• Optionally teachers from the child's or adolescent's home school
• Participation in the study by a caregiver from a residential group and/or teachers from the home school always requires the written consent of the child or adolescent and his or her legal guardians
• Sufficient German language skills

You may not qualify if:

• Children and adolescents or the attending attachment figure who do not speak or understand the German language
• In case of acute psychological strain during the course of the study, an emergency presentation will take place at the responsible hospital. In case of an inpatient stay of less than two weeks, the study participation is continued, in case of more than two weeks, discontinued.

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Universität Tübingen: collaborator

Study Sites (1)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (20)

• Abidin RR. Parenting Stress Index: A measure of the parent-child system. Zalaquett CP, Wood RJ, editors. Lanham Maryland, USA: Scarecrow Education; 1997.

  BACKGROUND

• Blömeke S, Kaiser G, Lehmann R. TEDS-M 2008. Professionelle Kompetenz und Lerngelegenheiten angehender Primarstufenlehrkräfte im internationalen Vergleich. Münster, Germany: Waxmann; 2010.

  BACKGROUND

• Brooke J. SUS - a quick and dirty usability scale. In: Jordan PW, Thomas B, Weerdmeester, BA, McClelland IL, editors. Usability Evaluation in Industry. London, UK: Taylor & Francis; 1996. p. 189-94.

  BACKGROUND

• Daniszewski TD. Teachers' mental health literacy and capacity towards student mental health. Electronic Thesis and Dissertation Repository. 2013:1165. https://ir.lib.uwo.ca/etd/1165

  BACKGROUND

• Döpfner M, Görtz-Dorten A. Diagnostik-System für psychische Störungen nach ICD-10 und DSM-5 für Kinder und Jugendliche - III (DISYPS-III). Göttingen, Germany: Hogrefe; 2017.

  BACKGROUND

• Franke GH. Brief-Symptom-Checklist (BSCL). Göttingen, Germany: Hogrefe; 2017.

  BACKGROUND

• Hatcher AK. Measuring mental health literacy in education. Electronic Thesis and Dissertation Repository. 2018:5313. https://ir.lib.uwo.ca/etd/5313

  BACKGROUND

• Konen T, Dirk J, Leonhardt A, Schmiedek F. The interplay between sleep behavior and affect in elementary school children's daily life. J Exp Child Psychol. 2016 Oct;150:1-15. doi: 10.1016/j.jecp.2016.04.003. Epub 2016 May 25.

  PMID: 27236036 BACKGROUND

• Kunter M, Baumert J, Leutner D, Terhart E, Seidel T, Dicke T, et al. Dokumentation der Erhebungsinstrumente der Projektphasen des BilWiss-Forschungsprogramms von 2009 bis 2016. Frankfurt am Main, Germany: Goethe-Universität Frankfurt; 2016.

  BACKGROUND

• Kunz Heim D, Trachsler E, Rindlisbacher S, Nido M. Schulen als Lernumgebungen für Lehrerinnen und Lehrer: Zusammenhänge zwischen Schulkontext, persönlichen Merkmalen und dem Weiterlernen von Lehrpersonen. Kreuzlingen, Switzerland: Pädagogische Hochschule Thurgau; 2007.

  BACKGROUND

• Lohaus A, Eschenbeck H, Kohlmann C-W, Klein-Heßling J. Fragebogen zur Erhebung von Stress und Stressbewältigung im Kindes- und Jugendalter - Revision (SSKJ 3-8 R). Göttingen, Germany: Hogrefe; 2018.

  BACKGROUND

• Mattejat F, Remschmidt H. Fragebogen zur Beurteilung der Behandlung (FBB). Göttingen, Germany: Hogrefe; 1999.

  BACKGROUND

• Neubauer A, Schmidt A, Schmiedek F, Dirk J. Dynamic Reciprocal Relations of Achievement Goal Orientations with Daily Experiences of Success and Failure: An Ambulatory Assessment Study. 2020; doi:10.31234/osf.io/uypex.

  BACKGROUND

• Reinke WM, Stormont M, Herman KC, Puri R, Goel N. Supporting children's mental health in schools: Teacher perceptions of needs, roles, and barriers. School Psychology Quarterly. 2011;26:1-13.

  BACKGROUND

• Schmidt A, Dirk J, Schmiedek F. The importance of peer relatedness at school for affective well-being in children: Between-and within-person associations. Social Development. 2019;28:873-92.

  BACKGROUND

• Schwarzer R, Jerusalem M. Skalen zur Erfassung von Lehrer- und Schülermerkmalen: Dokumentation der psychometrischen Verfahren im Rahmen der Wissenschaftlichen Begleitung des Modellversuchs Selbstwirksame Schulen. Berlin, Germany: Universität Berlin; 1999.

  BACKGROUND

• The KIDSCREEN Group Europe. The KIDSCREEN-27 Questionnaire - Quality of life questionnaire for children and adolescents. Lengerich, Germany: Pabst Science Publishers; 2006.

  BACKGROUND

• Tröster H. Eltern-Belastungs-Inventar (EBI): Deutsche Version des Parenting Stress Index (PSI) von R. R. Abidin. Göttingen, Germany: Hogrefe; 2010.

  BACKGROUND

• Vollmann K. Construction and evaluation of a questionnaire for measuring common factors in psychotherapy (FERT) [dissertation]. Tuebingen, Germany: University Tuebingen; 2010 [Available from: http://nbn-resolving.de/urn:nbn:de:bsz:21-opus-47705].

  BACKGROUND

• Finkbeiner M, Kuhnhausen J, Schmid J, Conzelmann A, Durrwachter U, Wahl LM, Kelava A, Gawrilow C, Renner TJ. E-Mental-Health aftercare for children and adolescents after partial or full inpatient psychiatric hospitalization: study protocol of the randomized controlled DigiPuR trial. Trials. 2022 Aug 26;23(1):713. doi: 10.1186/s13063-022-06508-1.

  PMID: 36028894 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Tobias J. Renner, Prof. Dr.

  University Hospital of Tuebingen, Germany

  STUDY DIRECTOR

• Caterina Gawrilow, Prof. Dr.

  Department of Psychology, University of Tuebingen, Germany

  STUDY DIRECTOR

• Kelava Augustin, Prof. Dr.

  Method Center, University of Tuebingen, Germany

  STUDY DIRECTOR

• Annette Conzelmann, Prof. Dr.

  University Hospital of Tuebingen, Germany

  PRINCIPAL INVESTIGATOR

• Dürrwächter Ute, Dr.

  University Hospital of Tuebingen, Germany

  PRINCIPAL INVESTIGATOR

• Schmid Johanna, Dr.

  University Hospital of Tuebingen, Germany

  PRINCIPAL INVESTIGATOR

• Kühnhausen Jan, Dr.

  University Hospital of Tuebingen, Germany

  PRINCIPAL INVESTIGATOR

• Finkbeiner Marlene

  University Hospital of Tuebingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking is only possible for data analysis, but not for participants, therapists, and study staff, because treatment is different in the two groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the research department of the Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy at the University Hospital Tuebingen

Model Details: Participants will be assigned to one of two groups. One group will be offered regular follow-up consultations in the clinic (Control group). The other group will receive a digital aftercare service, consisting of video calls and an app, for a period of up to eight weeks after discharge (Intervention group). These enable an uncomplicated and yet intensive exchange with the clinic from the comfort of the participants' own homes. To enable to optimally plan the treatment and assess its success, all participants complete questionnaires on multiple time points about different topics.

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: August 2, 2021
• Study Start: March 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)