Clinical trial NCT04986228: DigiPuR: Digitally Supported Psychotherapy and Reintegration
Official title: DigiPuR: Digitally Supported Psychotherapy and Reintegration of Children and Adolescents With Mental Disorders After Inpatient Psychiatric Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Disorder in Childhood
Keywords: Aftercare
E-Mental Health
Mental disorders
Triad
Adolescent
Child
Discharge
Readmission
Relapse prevention
Ambulatory assessment
Patient reported outcomes
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Universität Tübingen
First posted: 2021-08-02
Enrollment: 61
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in symptom severity (patient report)
timeFrame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Change in symptom severity (parent report)
timeFrame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Change in symptom severity (teacher report)
timeFrame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Change in Patients' Health-related quality of life
timeFrame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Change in Parents' Health-related quality of life
timeFrame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Patients' Satisfaction with treatment
timeFrame: Post (8 weeks after discharge)
measure: Parents' Satisfaction with treatment
timeFrame: Post (8 weeks after discharge)
measure: Therapists' Satisfaction with treatment
timeFrame: Post (8 weeks after discharge)
measure: Teachers' Satisfaction with treatment
timeFrame: Post (8 weeks after discharge)
measure: Difference and change in percentage of readmissions
timeFrame: Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Secondary outcomes:
measure: Change in patients' Stress Vulnerability
timeFrame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Change in patients' Stress Coping Strategies
timeFrame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Change in patients' school related self-efficacy
timeFrame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Change in patients' social self-efficacy
timeFrame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Change in parents' social self-efficacy
timeFrame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Change in teachers' self-efficacy
timeFrame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Change in Occupational well-being of teachers
timeFrame: Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Patients' satisfaction with technical components
timeFrame: Post (8 weeks after discharge)
measure: Parents' satisfaction with technical components
timeFrame: Post (8 weeks after discharge)
measure: Teachers' satisfaction with technical components
timeFrame: Post (8 weeks after discharge)
measure: Therapists' satisfaction with technical components
timeFrame: Post (8 weeks after discharge)
measure: Change in Parental stress
timeFrame: Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Parental strain
timeFrame: Admission
measure: Change in Competence self-concept of teachers in dealing with students
timeFrame: Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Change in teachers' professional competence in dealing with mentally ill students
timeFrame: Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
measure: Patients' expectation of change
timeFrame: Pre (at discharge)
measure: Parents' expectation of change
timeFrame: Pre (at discharge)
Other outcomes:
measure: Change in well-being (patients' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in affect (patients' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in sleep quality (patients' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in percentage of school absenteeism (patients' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in school days (patients' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in relationship with peers (patients' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in relationship with parents (patients' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in relationship with teachers (patients' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in well-being (parents' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in affect (parents' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in child's well-being (parents' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in relationship with the child (parents' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in perceived support received from the clinic (teachers' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in well-being (teachers' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in well-being of the student (teachers' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in the teacher-student relationship (teachers' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
measure: Change in the school day (teachers' Ambulatory Assessment)
timeFrame: Daily 2 weeks before discharge until 8 weeks after
Locations:
city: Tuebingen
country: Germany
facility: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy
state: Baden-Württemberg
Study officials:
affiliation: University Hospital of Tuebingen, Germany
name: Tobias J. Renner, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Department of Psychology, University of Tuebingen, Germany
name: Caterina Gawrilow, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Method Center, University of Tuebingen, Germany
name: Kelava Augustin, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: University Hospital of Tuebingen, Germany
name: Annette Conzelmann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Tuebingen, Germany
name: Dürrwächter Ute, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Tuebingen, Germany
name: Schmid Johanna, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Tuebingen, Germany
name: Kühnhausen Jan, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Tuebingen, Germany
name: Finkbeiner Marlene
role: PRINCIPAL_INVESTIGATOR
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