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DigiPuR: Digitally Supported Psychotherapy and Reintegration (DigiPuR)

Primary Purpose

Mental Disorder in Childhood

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Digital aftercare
TAU
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorder in Childhood focused on measuring Aftercare, E-Mental Health, Mental disorders, Triad, Adolescent, Child, Discharge, Readmission, Relapse prevention, Ambulatory assessment, Patient reported outcomes

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital aftercare

Treatment-as-usual (TAU)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 28, 2021
Last Updated
March 14, 2023
Sponsor
University Hospital Tuebingen
Collaborators
Universität Tübingen
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1. Study Identification

Unique Protocol Identification Number
NCT04986228
Brief Title
DigiPuR: Digitally Supported Psychotherapy and Reintegration
Acronym
DigiPuR
Official Title
DigiPuR: Digitally Supported Psychotherapy and Reintegration of Children and Adolescents With Mental Disorders After Inpatient Psychiatric Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
Collaborators
Universität Tübingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder in Childhood
Keywords
Aftercare, E-Mental Health, Mental disorders, Triad, Adolescent, Child, Discharge, Readmission, Relapse prevention, Ambulatory assessment, Patient reported outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Masking is only possible for data analysis, but not for participants, therapists, and study staff, because treatment is different in the two groups.
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital aftercare
Arm Type
Experimental
Arm Description
The group with the new digital aftercare is compared with the active control group with regular aftercare.
Arm Title
Treatment-as-usual (TAU)
Arm Type
Active Comparator
Arm Description
The group with regular aftercare (TAU) serves as an active control group.
Intervention Type
Other
Intervention Name(s)
Digital aftercare
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in symptom severity (patient report)
Description
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.
Time Frame
Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Change in symptom severity (parent report)
Description
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.
Time Frame
Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Change in symptom severity (teacher report)
Description
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.
Time Frame
Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Change in Patients' Health-related quality of life
Description
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.
Time Frame
Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Change in Parents' Health-related quality of life
Description
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.
Time Frame
Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Patients' Satisfaction with treatment
Description
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.
Time Frame
Post (8 weeks after discharge)
Title
Parents' Satisfaction with treatment
Description
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.
Time Frame
Post (8 weeks after discharge)
Title
Therapists' Satisfaction with treatment
Description
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.
Time Frame
Post (8 weeks after discharge)
Title
Teachers' Satisfaction with treatment
Description
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.
Time Frame
Post (8 weeks after discharge)
Title
Difference and change in percentage of readmissions
Description
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.
Time Frame
Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Secondary Outcome Measure Information:
Title
Change in patients' Stress Vulnerability
Description
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.
Time Frame
Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Change in patients' Stress Coping Strategies
Description
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.
Time Frame
Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Change in patients' school related self-efficacy
Description
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.
Time Frame
Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Change in patients' social self-efficacy
Description
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.
Time Frame
Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Change in parents' social self-efficacy
Description
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.
Time Frame
Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Change in teachers' self-efficacy
Description
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.
Time Frame
Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Change in Occupational well-being of teachers
Description
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.
Time Frame
Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Patients' satisfaction with technical components
Description
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.
Time Frame
Post (8 weeks after discharge)
Title
Parents' satisfaction with technical components
Description
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.
Time Frame
Post (8 weeks after discharge)
Title
Teachers' satisfaction with technical components
Description
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.
Time Frame
Post (8 weeks after discharge)
Title
Therapists' satisfaction with technical components
Description
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.
Time Frame
Post (8 weeks after discharge)
Title
Change in Parental stress
Description
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.
Time Frame
Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Parental strain
Description
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.
Time Frame
Admission
Title
Change in Competence self-concept of teachers in dealing with students
Description
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.
Time Frame
Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Change in teachers' professional competence in dealing with mentally ill students
Description
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.
Time Frame
Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge)
Title
Patients' expectation of change
Description
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.
Time Frame
Pre (at discharge)
Title
Parents' expectation of change
Description
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.
Time Frame
Pre (at discharge)
Other Pre-specified Outcome Measures:
Title
Change in well-being (patients' Ambulatory Assessment)
Description
In the ambulatory assessment, children and adolescents provide information on their general well-being (pilot study). Possible values range from 1 to 5 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in affect (patients' Ambulatory Assessment)
Description
In the ambulatory assessment, children and adolescents provide information on their affect (Könen, Dirk, Leonhardt, & Schmiedek, 2016). Possible values range from 12 to 60 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in sleep quality (patients' Ambulatory Assessment)
Description
In the ambulatory assessment, children and adolescents provide information on their sleep quality (Könen et al., 2016). Possible values range from 2 to 10 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in percentage of school absenteeism (patients' Ambulatory Assessment)
Description
In the ambulatory assessment, children and adolescents provide information on their school absenteeism. Possible values range from 0 to 100 percent of absent days, with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in school days (patients' Ambulatory Assessment)
Description
In the ambulatory assessment, children and adolescents provide information on their school days (KIDSCREEN Group Europe, 2006; Neubauer, Schmidt, Schmiedek, & Dirk, 2020). Possible values range from 4 to 20 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in relationship with peers (patients' Ambulatory Assessment)
Description
In the ambulatory assessment, children and adolescents provide information on their relationships with peers (Schmidt, Dirk, & Schmiedek, 2019). Possible values range from 4 to 20 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in relationship with parents (patients' Ambulatory Assessment)
Description
In the ambulatory assessment, children and adolescents provide information on their relationships with their parents (adapted from Schmidt, Dirk, & Schmiedek, 2019). Possible values range from 4 to 20 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in relationship with teachers (patients' Ambulatory Assessment)
Description
In the ambulatory assessment, children and adolescents provide information on their relationships with their teachers (adapted from KIDSCREEN Group Europe, 2006). Possible values range from 1 to 5 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in well-being (parents' Ambulatory Assessment)
Description
In the ambulatory assessment, parents provide data on their own general well-being (pilot study). Possible values range from 1 to 5 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in affect (parents' Ambulatory Assessment)
Description
In the ambulatory assessment, parents provide data on their affect (Könen et al., 2016). Possible values range from 12 to 60 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in child's well-being (parents' Ambulatory Assessment)
Description
In the ambulatory assessment, parents provide data on their child's well-being (pilot study). Possible values range from 1 to 5 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in relationship with the child (parents' Ambulatory Assessment)
Description
In the ambulatory assessment, parents provide data on their relationship with the child (adapted from Schmidt et al., 2019).Possible values range from 2 to 10 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in perceived support received from the clinic (teachers' Ambulatory Assessment)
Description
In the ambulatory assessment, teachers provide data on the perceived support they received from the clinic (self-development). Possible values range from 1 to 5 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in well-being (teachers' Ambulatory Assessment)
Description
In the ambulatory assessment, teachers provide data on their well-being (self-developed). Possible values range from 2 to 10 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in well-being of the student (teachers' Ambulatory Assessment)
Description
In the ambulatory assessment, teachers provide data on the well-being of the student (self-developed). Possible values range from 1 to 5 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in the teacher-student relationship (teachers' Ambulatory Assessment)
Description
In the ambulatory assessment, teachers provide data on the teacher-student relationship (adapted from KIDSCREEN Group Europe, 2006). Possible values range from 2 to 10 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after
Title
Change in the school day (teachers' Ambulatory Assessment)
Description
In the ambulatory assessment, teachers provide data on the school day (KIDSCREEN Group Europe, 2006; Neubauer et al., 2020). Possible values range from 3 to 15 with higher scores indicating a better outcome.
Time Frame
Daily 2 weeks before discharge until 8 weeks after

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias J. Renner, Prof. Dr.
Organizational Affiliation
University Hospital of Tuebingen, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Caterina Gawrilow, Prof. Dr.
Organizational Affiliation
Department of Psychology, University of Tuebingen, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kelava Augustin, Prof. Dr.
Organizational Affiliation
Method Center, University of Tuebingen, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Annette Conzelmann, Prof. Dr.
Organizational Affiliation
University Hospital of Tuebingen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dürrwächter Ute, Dr.
Organizational Affiliation
University Hospital of Tuebingen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Schmid Johanna, Dr.
Organizational Affiliation
University Hospital of Tuebingen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kühnhausen Jan, Dr.
Organizational Affiliation
University Hospital of Tuebingen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Finkbeiner Marlene
Organizational Affiliation
University Hospital of Tuebingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy
City
Tuebingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
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DigiPuR: Digitally Supported Psychotherapy and Reintegration

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