Mental Disorder in ChildhoodDigiPuRNCT04986228
DigiPuR: Digitally Supported Psychotherapy and Reintegration
A study testing Digital aftercare and TAU in people with Mental Disorder in Childhood, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Mental Disorder in Childhood
- What is being tested?
- Digital aftercare and TAU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: DigiPuR: Digitally Supported Psychotherapy and Reintegration of Children and Adolescents With Mental Disorders After Inpatient Psychiatric Treatment
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.
Read the detailed description
Sample: All children and adolescents who were treated as partial or full inpatients in the Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy at the University Hospital Tuebingen, Germany as well as a primary attachment figure (parent or caregiver from a residential group) can participate in the study. Optionally, one or more teachers from the child's or adolescent's home school may also participate. The aim is to include N = 50 triplets (total sample about 150 persons) with 50 children and adolescents (n = 25 per group) and one attachment figure and one teacher each. The sample size was based on current RCT studies in this field as well as on the discharge numbers of the department.
Interventions: Participants will be assigned to one of two groups after informed written consent using a randomization list.
Intervention group: In the intervention group, 6 no longer than 50-minute video calls take place between the family and the case-leading therapist of the previous inpatient treatment (weekly until 4 weeks after discharge, then biweekly until 8 weeks after discharge). In order to adapt the aftercare to the needs of the patients, the case-leading therapist decides on the duration of the sessions as well as their participants (patients and/or parents and/or external support systems). The case-specific different contents are linked to the previous inpatient, behavioral therapy-oriented treatment with focus on the transfer of learned strategies into daily life. If patients and parents have agreed to the participation of teachers, three separate 30-45-minute video or telephone conferences are additionally conducted with one or more teachers from the home school and the case-leading therapist in the period up to 8 weeks after discharge. In addition, a handbook with the titel "Mental Illness in the School Environment" was developed, which enables teachers further information and support. Beyond the sessions with the case-leading therapists, the children and adolescents, parents and teachers have the opportunity to clarify content-related questions or organizational matters with the therapist via a secure messenger system on their own smartphone. Emergencies, on the other hand, are handled via the emergency number of the responsible clinic.
Control group: In the control group, the regular aftercare (treatment-as-usual) of the Department takes place. The regular aftercare usually includes a 50-minute follow-up consultation with the case-leading therapist in the clinic about 6 weeks after discharge.
Assessments: The assessments are the same in both groups.
Pre-Post-FollowUp: The admission and discharge assessment as part of the standard hospital assessment will be conducted using paper questionnaires (where necessary in exceptional cases online) by trained staff during the inpatient hospital stay in the period from preliminary talk on admission to one week after admission and in the period from one week before discharge to discharge (pre). For the post, follow-up 1, and follow-up 2 assessments (8, 24, and 37 weeks after discharge), participants receive an email with a link to an online survey that they can complete at home for one week using the browser on their computer, tablet, or smartphone. At each assessment point, the survey takes no longer than about 45 minutes to complete.
Ambulatory Assessment: The ambulatory assessment consists of questions about well-being, relationships, and the school situation that are answered daily from two weeks before to eight weeks after discharge in approximately 5 minutes between 5 and 9 in the evening by the children and adolescents, the participating attachment figure, and, if teachers participate, a teacher from the home school on their own smartphone. Teachers answer the questions only on school days and are given a larger time frame to respond to increase compliance. The questions for children and adolescents are presented in written and audiovisual form allowing children who are not yet confident readers to have the questions read aloud. Children and adolescents, parents, and teachers are reminded of daily questioning through alerts and can postpone alerts three times. Data collected in the ambulatory assessment is analyzed individually on a weekly basis by summarizing and graphing all responses. This overview of the patient's answers during the previous week(s) can be used by the case-leading therapist as a basis for the next regular video call.
- Conditions
- Mental Disorder in Childhood
- Being tested
- Digital aftercare, TAU
- Keywords
- Aftercare, E-Mental Health, Mental disorders, Triad, Adolescent, Child, Discharge, Readmission, Relapse prevention, Ambulatory assessment, Patient reported outcomes
- Medical subject headings
- Neurodevelopmental Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital aftercareOther
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.
TAUOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital aftercare | Experimental | The group with the new digital aftercare is compared with the active control group with regular aftercare. Receives: Other: Digital aftercare |
| Treatment-as-usual (TAU) | Active comparator | The group with regular aftercare (TAU) serves as an active control group. Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Secondary outcomes (17)
Change in patients' Stress Vulnerability
Patients' stress vulnerability is measured with the appropriate sub-scale of the Questionnaire for the Survey of Stress and Stress Coping in Childhood and Adolescence - Revision (SSKJ 3-8R; Lohaus, Eschenbeck, Kohlmann, \& Klein-Heßling, 2018), 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 7 to 28 with higher scores indicating a worse outcome.
Measured: 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
Patients' stress coping strategies are measured with the appropriate sub-scales of the Questionnaire for the Survey of Stress and Stress Coping in Childhood and Adolescence - Revision (SSKJ 3-8R; Lohaus, Eschenbeck, Kohlmann, \& Klein-Heßling, 2018), 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 30 to 150 with higher scores indicating a better outcome.
Measured: 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
School related self-efficacy from the perspective of patients is measured based on the mean value of items from the WIRKSCHUL scales (Schulbezogene Selbstwirksamkeitserwartung [School-related self-efficacy]; Schwarzer \& Jerusalem, 1999), at the time of admission and discharge from inpatient child and adolescent psychiatric treatment, and at 8, 24, and 37 weeks after discharge. Possible values range from 8 to 40 with higher scores indicating a better outcome.
Measured: 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
Social self-efficacy from the perspective of patients is measured based on the mean value of items from the WIRKSOZ scales (Selbstwirksamkeitserwartung im Umgang mit sozialen Anforderungen [Self-efficacy in dealing with social demands]; Schwarzer \& Jerusalem, 1999), at the time of admission and discharge from inpatient child and adolescent psychiatric treatment, and at 8, 24, and 37 weeks after discharge. Possible values range from 8 to 40 with higher scores indicating a better outcome.
Measured: 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
Self-efficacy from the perspective of parents is measured based on the mean of adequately adapted items from the WIRKLEHR scale (Skala Lehrer-Selbstwirksamkeit [Teacher Self-Efficacy Scale]; Schwarzer \& Jerusalem, 1999), at the time of admission and discharge and at 8, 24, and 37 weeks after discharge. Possible values range from 8 to 40 with higher scores indicating a better outcome.
Measured: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Change in teachers' self-efficacy
Self-efficacy from the perspective of teachers is measured based on the mean value of adequately adapted items from the WIRKLEHR scale (Skala Lehrer-Selbstwirksamkeit [Teacher Self-Efficacy Scale]; Schwarzer \& Jerusalem, 1999), at the time of admission and discharge and at 8, 24, and 37 weeks after discharge. Possible values range from 10 to 50 with higher scores indicating a better outcome.
Measured: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Change in Occupational well-being of teachers
Teachers' occupational well-being is measured using the scales Emotional Exhaustion and Enthusiasm for Teaching (Kunter, Baumert, Leutner, Terhart, Seidel, Dicke, et al., 2016) at the time of discharge from inpatient child and adolescent psychiatric treatment and at 8, 24, and 37 weeks after discharge. Possible values range from 5 to 15 with higher scores indicating a better outcome.
Measured: Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Patients' satisfaction with technical components
Patients' satisfaction with technical components is measured using thematically adapted items of the System Usability Scale (SUS; Brooke, 1996) at 8 weeks after discharge. Possible values range from 0 to 100 with higher scores indicating a better outcome.
Measured: Post (8 weeks after discharge)
Parents' satisfaction with technical components
Parents' satisfaction with technical components is measured using thematically adapted items of the System Usability Scale (SUS; Brooke, 1996) at 8 weeks after discharge. Possible values range from 0 to 100 with higher scores indicating a better outcome.
Measured: Post (8 weeks after discharge)
Teachers' satisfaction with technical components
Teachers' satisfaction with technical components is measured using thematically adapted items of the System Usability Scale (SUS; Brooke, 1996) at 8 weeks after discharge. Possible values range from 0 to 100 with higher scores indicating a better outcome.
Measured: Post (8 weeks after discharge)
Therapists' satisfaction with technical components
Therapists' satisfaction with technical components is measured using thematically adapted items of the System Usability Scale (SUS; Brooke, 1996) at 8 weeks after discharge. Possible values range from 0 to 100 with higher scores indicating a better outcome.
Measured: Post (8 weeks after discharge)
Change in Parental stress
Parental stress is measured using the Eltern-Belastungs-Inventar (EBI; Tröster, 2010 [i.e., German version of the Parenting Stress Index; Abidin, 1997]), at the time of the child's admission and discharge from inpatient child and adolescent psychiatric treatment, and at 8, 24, and 37 weeks after discharge. Possible values range from 48 to 240 with higher scores indicating a worse outcome.
Measured: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Parental strain
Parental strain is measured with the Brief Symptom Checklist (BSCL; Franke, 2017) at the time of the child's admission for inpatient child and adolescent psychiatric treatment. Possible values range from 53 to 265 with higher scores indicating a worse outcome.
Measured: Admission
Change in Competence self-concept of teachers in dealing with students
Teachers' competence self-concept is measured using the identically named scale (Kunz Heim, Trachsler, Rindlisbacher, \& Nido, 2007) at the time of admission and discharge of the student from inpatient child and adolescent psychiatric treatment, as well as at 8, 24, and 37 weeks after discharge. Possible values range from 5 to 20 with higher scores indicating a better outcome.
Measured: Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Change in teachers' professional competence in dealing with mentally ill students
Teachers' professional competence in dealing with mentally ill students is measured exploratively using the mean score of a self-developed scale, based on self-developed items and items from different studies in the field of Mental Health Literacy (Daniszewski, 2013; Hatcher, 2018; Reinke, Stormont, Herman, Puri, \& Goel, 2011) and from teacher survey studies (Blömeke, Kaiser, \& Lehmann, 2010; Kunter et al., 2016; Schwarzer \& Jerusalem, 1999) at the time of the student's discharge from inpatient child and adolescent psychiatric treatment and 8, 24, and 37 weeks after discharge. Possible values of the total scale range from 24 to 120 with higher scores indicating a better outcome.
Measured: Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Patients' expectation of change
Patients' expectation of change in relation to the aftercare is measured using the mean value of 4 thematically adapted items from the "Patient's expectation of change" of the Questionnaire for Measuring Common Factors in Psychotherapy (FERT; Vollmann, 2010). Possible values range from 0 to 16 with higher scores indicating a better outcome.
Measured: Pre (at discharge)
Parents' expectation of change
Parents' expectation of change in relation to the aftercare is measured using the mean value of 4 thematically adapted items from the scale "Patient's expectation of change" of the Questionnaire for Measuring Common Factors in Psychotherapy (FERT; Vollmann, 2010). Possible values range from 0 to 16 with higher scores indicating a better outcome.
Measured: Pre (at discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Mar 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Mental Disorder in ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Tübingen
- Responsible party
- Principal investigator, PD Dr. Annette Conzelmann, University Hospital Tuebingen
- Investigators
- Tobias J. Renner, Prof. Dr., Study director, University Hospital of Tuebingen, GermanyCaterina Gawrilow, Prof. Dr., Study director, Department of Psychology, University of Tuebingen, GermanyKelava Augustin, Prof. Dr., Study director, Method Center, University of Tuebingen, GermanyAnnette Conzelmann, Prof. Dr., Principal investigator, University Hospital of Tuebingen, GermanyDürrwächter Ute, Dr., Principal investigator, University Hospital of Tuebingen, GermanySchmid Johanna, Dr., Principal investigator, University Hospital of Tuebingen, GermanyKühnhausen Jan, Dr., Principal investigator, University Hospital of Tuebingen, GermanyFinkbeiner Marlene, Principal investigator, University Hospital of Tuebingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986228
- Sponsor's protocol ID
- 53-5400.1-005/09
- Acronym
- DigiPuR
- Status last verified
- Apr 2026
- First submitted
- 28 May 2021
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abidin RR. Parenting Stress Index: A measure of the parent-child system. Zalaquett CP, Wood RJ, editors. Lanham Maryland, USA: Scarecrow Education; 1997.
Blömeke S, Kaiser G, Lehmann R. TEDS-M 2008. Professionelle Kompetenz und Lerngelegenheiten angehender Primarstufenlehrkräfte im internationalen Vergleich. Münster, Germany: Waxmann; 2010.
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.
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
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.
Franke GH. Brief-Symptom-Checklist (BSCL). Göttingen, Germany: Hogrefe; 2017.
Hatcher AK. Measuring mental health literacy in education. Electronic Thesis and Dissertation Repository. 2018:5313. https://ir.lib.uwo.ca/etd/5313
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.
PubMed 27236036Kunter 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.
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.
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.
Mattejat F, Remschmidt H. Fragebogen zur Beurteilung der Behandlung (FBB). Göttingen, Germany: Hogrefe; 1999.
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.
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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DigiPuR: Digitally Supported Psychotherapy and Reintegration of Children and Adolescents With Mental Disorders After Inpatient Psychiatric Treatment
- ClinicalTrials.gov ID
- NCT04986228
- Acronym / sponsor ID
- DigiPuR / 53-5400.1-005/09
- Conditions
- Mental Disorder in Childhood
- Keywords
- Aftercare, E-Mental Health, Mental disorders, Triad, Adolescent, Child, Discharge, Readmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Universität Tübingen
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sample: All children and adolescents who were treated as partial or full inpatients in the Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy at the University Hospital Tuebingen, Germany as well as a primary attachment figure (parent or caregiver from a residential group) can participate in the study. Optionally, one or more teachers from the child's or adolescent's home school may also participate. The aim is to include N = 50 triplets (total sample about 150 persons) with 50 children and adolescents (n = 25 per group) and one attachment figure and one teacher each. The sample size was based on current RCT studies in this field as well as on the discharge numbers of the department.
Interventions: Participants will be assigned to one of two groups after informed written consent using a randomization list.
Intervention group: In the intervention group, 6 no longer than 50-minute video calls take place between the family and the case-leading therapist of the previous inpatient treatment (weekly until 4 weeks after discharge, then biweekly until 8 weeks after discharge). In order to adapt the aftercare to the needs of the patients, the case-leading therapist decides on the duration of the sessions as well as their participants (patients and/or parents and/or external support systems). The case-specific different contents are linked to the previous inpatient, behavioral therapy-oriented treatment with focus on the transfer of learned strategies into daily life. If patients and parents have agreed to the participation of teachers, three separate 30-45-minute video or telephone conferences are additionally conducted with one or more teachers from the home school and the case-leading therapist in the period up to 8 weeks after discharge. In addition, a handbook with the titel "Mental Illness in the School Environment" was developed, which enables teachers further information and support. Beyond the sessions with the case-leading therapists, the children and adolescents, parents and teachers have the opportunity to clarify content-related questions or organizational matters with the therapist via a secure messenger system on their own smartphone. Emergencies, on the other hand, are handled via the emergency number of the responsible clinic.
Control group: In the control group, the regular aftercare (treatment-as-usual) of the Department takes place. The regular aftercare usually includes a 50-minute follow-up consultation with the case-leading therapist in the clinic about 6 weeks after discharge.
Assessments: The assessments are the same in both groups.
Pre-Post-FollowUp: The admission and discharge assessment as part of the standard hospital assessment will be conducted using paper questionnaires (where necessary in exceptional cases online) by trained staff during the inpatient hospital stay in the period from preliminary talk on admission to one week after admission and in the period from one week before discharge to discharge (pre). For the post, follow-up 1, and follow-up 2 assessments (8, 24, and 37 weeks after discharge), participants receive an email with a link to an online survey that they can complete at home for one week using the browser on their computer, tablet, or smartphone. At each assessment point, the survey takes no longer than about 45 minutes to complete.
Ambulatory Assessment: The ambulatory assessment consists of questions about well-being, relationships, and the school situation that are answered daily from two weeks before to eight weeks after discharge in approximately 5 minutes between 5 and 9 in the evening by the children and adolescents, the participating attachment figure, and, if teachers participate, a teacher from the home school on their own smartphone. Teachers answer the questions only on school days and are given a larger time frame to respond to increase compliance. The questions for children and adolescents are presented in written and audiovisual form allowing children who are not yet confident readers to have the questions read aloud. Children and adolescents, parents, and teachers are reminded of daily questioning through alerts and can postpone alerts three times. Data collected in the ambulatory assessment is analyzed individually on a weekly basis by summarizing and graphing all responses. This overview of the patient's answers during the previous week(s) can be used by the case-leading therapist as a basis for the next regular video call.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digital aftercare | Experimental | Other: Digital aftercareThe group with the new digital aftercare is compared with the active control group with regular aftercare. |
| Treatment-as-usual (TAU) | Active comparator | Other: TAUThe group with regular aftercare (TAU) serves as an active control group. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital aftercareThe 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. | Other | Digital aftercare |
| TAUThe 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. | Other | Treatment-as-usual (TAU) |
Primary outcome
Change in symptom severity (patient report)
Time frame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
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.
Change in symptom severity (parent report)
Time frame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
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.
Change in symptom severity (teacher report)
Time frame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
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.
Change in Patients' Health-related quality of life
Time frame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
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.
Change in Parents' Health-related quality of life
Time frame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
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.
Patients' Satisfaction with treatment
Time frame: Post (8 weeks after discharge)
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.
Parents' Satisfaction with treatment
Time frame: Post (8 weeks after discharge)
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.
Therapists' Satisfaction with treatment
Time frame: Post (8 weeks after discharge)
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.
Teachers' Satisfaction with treatment
Time frame: Post (8 weeks after discharge)
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.
Difference and change in percentage of readmissions
Time frame: Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
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.
17 secondary outcomes
Change in patients' Stress Vulnerability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Change in teachers' self-efficacy
Time frame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Change in Occupational well-being of teachers
Time frame: Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Patients' satisfaction with technical components
Time frame: Post (8 weeks after discharge)
Parents' satisfaction with technical components
Time frame: Post (8 weeks after discharge)
Teachers' satisfaction with technical components
Time frame: Post (8 weeks after discharge)
Therapists' satisfaction with technical components
Time frame: Post (8 weeks after discharge)
Change in Parental stress
Time frame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Parental strain
Time frame: Admission
Change in Competence self-concept of teachers in dealing with students
Time frame: Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Change in teachers' professional competence in dealing with mentally ill students
Time frame: Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Patients' expectation of change
Time frame: Pre (at discharge)
Parents' expectation of change
Time frame: Pre (at discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- BackgroundAbidin RR. Parenting Stress Index: A measure of the parent-child system. Zalaquett CP, Wood RJ, editors. Lanham Maryland, USA: Scarecrow Education; 1997.
- BackgroundBlömeke S, Kaiser G, Lehmann R. TEDS-M 2008. Professionelle Kompetenz und Lerngelegenheiten angehender Primarstufenlehrkräfte im internationalen Vergleich. Münster, Germany: Waxmann; 2010.
- BackgroundBrooke 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.
- BackgroundDaniszewski 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
- BackgroundDöpfner 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.
- BackgroundFranke GH. Brief-Symptom-Checklist (BSCL). Göttingen, Germany: Hogrefe; 2017.
- BackgroundHatcher AK. Measuring mental health literacy in education. Electronic Thesis and Dissertation Repository. 2018:5313. https://ir.lib.uwo.ca/etd/5313
- Background: PubMed 27236036Konen 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.
- BackgroundKunter 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.
- BackgroundKunz 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.
- BackgroundLohaus 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.
- BackgroundMattejat F, Remschmidt H. Fragebogen zur Beurteilung der Behandlung (FBB). Göttingen, Germany: Hogrefe; 1999.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias J. Renner, Prof. Dr. study director
University Hospital of Tuebingen, Germany
Caterina Gawrilow, Prof. Dr. study director
Department of Psychology, University of Tuebingen, Germany
Kelava Augustin, Prof. Dr. study director
Method Center, University of Tuebingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital aftercare and TAU in people with Mental Disorder in Childhood, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom severity (patient report) (time frame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04986228, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.