DigiPuR: Digitally Supported Psychotherapy and Reintegration

Study Overview
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Brief Summary
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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
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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.

Official Title
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DigiPuR: Digitally Supported Psychotherapy and Reintegration of Children and Adolescents With Mental Disorders After Inpatient Psychiatric Treatment

Conditions
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Mental Disorder in Childhood

Intervention / Treatment
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* Other: Digital aftercare
* Other: TAU


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital aftercare<br>The group with the new digital aftercare is compared with the active control group with regular aftercare. | Other: Digital aftercare<br>* 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.<br>|
| Active Comparator: Treatment-as-usual (TAU)<br>The group with regular aftercare (TAU) serves as an active control group. | Other: TAU<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptom severity (patient report) | Symptom severity as assessed by patients is measured using the Diagnostic System for Mental Disorders according to ICD-10 and DSM-5 for Children and Adolescents - III Screening questionnaire (DISYPS-III SCREEN; Döpfner & Görtz-Dorten, 2017) at the time of admission and discharge of inpatient child and adolescent psychiatric treatment, and at 8, 24, and 37 weeks after discharge. Possible values range from 49 to 174 with higher scores indicating a worse outcome. | Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge) | 
| Change in symptom severity (parent report) | Symptom severity as assessed by parents is measured using the Diagnostic System for Mental Disorders according to ICD-10 and DSM-5 for Children and Adolescents - III Screening questionnaire (DISYPS-III SCREEN; Döpfner & Görtz-Dorten, 2017) at the time of admission and discharge of inpatient child and adolescent psychiatric treatment, and at 8, 24, and 37 weeks after discharge. Possible values range from 49 to 174 with higher scores indicating a worse outcome. | Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge) | 
| Change in symptom severity (teacher report) | Symptom severity as assessed by teachers is measured using the Diagnostic System for Mental Disorders according to ICD-10 and DSM-5 for Children and Adolescents - III Screening questionnaire (DISYPS-III SCREEN; Döpfner & Görtz-Dorten, 2017) at the time of admission and discharge of inpatient child and adolescent psychiatric treatment, and at 8, 24, and 37 weeks after discharge. Possible values range from 49 to 174 with higher scores indicating a worse outcome. | Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge) | 
| Change in Patients' Health-related quality of life | Health-related quality of life as assessed by patients is measured using the Health Related Quality of Life Questionnaire for Children and Young People and their Parents (KIDSCREEN-27; KIDSCREEN Group Europe, 2006) at the time of admission and discharge of inpatient child and adolescent psychiatric treatment, and at 8, 24, and 37 weeks after discharge. Possible values range from 27 to 135 with higher scores indicating a better outcome. | Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge) | 
| Change in Parents' Health-related quality of life | Health-related quality of life as assessed by parents is measured using the Health Related Quality of Life Questionnaire for Children and Young People and their Parents (KIDSCREEN-27; KIDSCREEN Group Europe, 2006) at the time of admission and discharge of inpatient child and adolescent psychiatric treatment, and at 8, 24, and 37 weeks after discharge. Possible values range from 27 to 135 with higher scores indicating a better outcome. | Admission, Pre (at discharge), Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge) | 
| Patients' Satisfaction with treatment | Satisfaction with treatment as assessed by patients is measured using questionnaire versions based on the Questionnaire for the assessment of treatment (FBB; Mattejat & Remschmidt, 1999) at 8 weeks after discharge. Possible values range from 0 to 76 with higher scores indicating a better outcome. | Post (8 weeks after discharge) | 
| Parents' Satisfaction with treatment | Satisfaction with treatment as assessed by parents is measured using questionnaire versions based on the Questionnaire for the assessment of treatment (FBB; Mattejat & Remschmidt, 1999) at 8 weeks after discharge. Possible values range from 0 to 84 with higher scores indicating a better outcome. | Post (8 weeks after discharge) | 
| Therapists' Satisfaction with treatment | Satisfaction with treatment as assessed by therapists is measured using questionnaire versions based on the Questionnaire for the assessment of treatment (FBB; Mattejat & Remschmidt, 1999) at 8 weeks after discharge. Possible values range from 0 to 72 with higher scores indicating a better outcome. | Post (8 weeks after discharge) | 
| Teachers' Satisfaction with treatment | Satisfaction with treatment as assessed by teachers is measured using questionnaire versions based on the Questionnaire for the assessment of treatment (FBB; Mattejat & Remschmidt, 1999) at 8 weeks after discharge. Possible values range from 0 to 56 with higher scores indicating a better outcome. | Post (8 weeks after discharge) | 
| Difference and change in percentage of readmissions | The percentage of readmissions is obtained by analyzing internal hospital controlling data. The change of these percentages over time is considered and compared across the study groups. | Post (8 weeks after discharge), FollowUp1 (24 weeks after discharge), FollowUp2 (37 weeks after discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Pre (at discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aftercare, E-Mental Health, Mental disorders, Triad, Adolescent, Child, Discharge, Readmission, Relapse prevention, Ambulatory assessment, Patient reported outcomes