In order to identify psychological stress in children and adolescents of mentally ill parents as early as possible, four special intervention programs (CHIMPS-therapy, CHIMPS-Prevention-single, CHIMPS-MFT-group, iCHIMPS) have been developed. These four intervention programs are based on the initial medical situation, indication and need of the families. Thereby, an individually tailored counseling service will be provided. With this current project, the four counseling approaches will be tested at 19 study sites in 12 federal states in Germany. Moreover, the interventions long-term efficacy will be evaluated.
The central objectives of the study at hand are the implementation, evaluation and transfer of three evidence-based innovative forms of care (CHIMPS-Therapy, CHIMPS-MFT-Group, CHIMPS-Prevention-Single) for children and adolescents (aged 3 to 18 years) with mentally ill parents at the 19 participating study cites in 12 federal states of Germany. In addition, iCHIMPS, an online intervention based on the CHIMPS concept for the whole family, will be developed. The four innovative forms of care include diagnostic, prevention and - if needed - therapy in order to treat psychological symptoms of children and adolescents as early as possible. Thereby, chronification will be prevented and the cycle of transgenerational transmissions of psychiatric disorders will be broken. Each of the four interventions will be evaluated in a separate prospective, randomized-controlled trial (RCT); overall, four randomized-controlled trials will be performed. Each of the four control groups receives treatment as usual (TAU). Each of the four studies will include two groups: one intervention group (IG) and one control group (KG), i.e. CHIMPS-T vs. KG (TAU), CHIMPS-MFT-group vs. KG (TAU), CHIMPs-P vs. KG (TAU), iCHIMPS vs. KG (TAU). Central psychosocial outcomes will be assessed at four time points (t1, t2, t3, t4) at baseline as well as after six, 12 and 18 months. Due to a longer development period, iCHIMPS will have three times of measurement over a period of nine months (baseline, post-intervention after 2 months as well as six-months-followup) within the project term. Outcomes will be assessed from the perspectives of the mentally ill parent, the partner (if available), every child and adolescent (0 - 9 years only external assessment; from 10 years of age additional self-assessment) and the professionals. A special characteristic of the study at hand is the comprehensive accompanying evaluation of medical biometry, health economics and qualitative evaluation. In addition, various sub-projects for systematic implementation will be conducted: optimization of pathway to care, knowledge and skills of professionals, development of a screening instrument and external quality assurance. In order to evaluate the effect of these three implementation strategies, an implementation study with a cluster-randomized trial was designed. Nineteen clinical centers are taking part in the implementation study. Nine of the nineteen clinical centers will receive the support of one of the three implementation strategies, the other ten clinical centers make up the control group and do not get a specific implementation support. The allocation is randomized. With three questionnaires in the investigator's implementation study we want to identify factors hindering or promoting implementation processes.
CHIMPS-T (Children of mentally ill parents) is a family-oriented lowfrequency brief therapy for diagnosis and treatment of mental disorders in children and adolescents.
CHIMPS-P is a family-oriented prevention for children and adolescents without signs of mental disorders in the initial screening. These families will receive the 3 family sessions from the modular CHIMPS intervention.
The CHIMPS-MFT-group is a prevention with a multi-family setting based on the CHIMPS approach. The multi-family intervention comprises 8 sessions for children and adolescents without psychiatric disorders and their families.
University Medical Center Universitätsklinikum Hamburg-Eppendorf, Klinik für Kinder- und Jugendmedizin
Hamburg, Germany
RECRUITINGChildren's and adolescent's psychiatric symptomatology (CBCL)
Children's and adolescent's psychiatric symptomatology, assessed from the perspective of the parents by the Child Behaviour Checklist (CBCL 1,5-5; Achenbach \& Rescorla, 2000), (CBCL 6-18R; Döpfner, Pflück, Kinnen, \& Arbeitsgruppe Deutsche Child Behavior Checklist, 2014).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Sociodemographic information
Sociodemographic information of the parents, assessed from the perspective of the parents.
Time frame: At baseline of the study]
Psychiatric disorders of the children and adolescents (YSR)
Psychiatric disorders of the children and adolescents, assessed from the perspective of the parents by the "Youth Self Report" (YSR; Döpfner, Pflück, Kinnen \& Arbeitsgruppe Deutsche Child Behavior Checklist, 2014).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Psychiatric disorders of the children and adolescents (K-SADS-PL)
Psychiatric disorders of the children and adolescents, assessed from the perspective of an external rater by the Kiddie-SADS (K-SADS-PL) (Delmo, Weiffenbach, Gabriel, Stadler \& Poustka, 2001).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Psychiatric symptomatology of the children and adolescents (GAF)
Psychiatric symptomatology of the children and adolescents, assessed from the perspective of an external rater by the "Global Assessment of Functioning" (GAF; Saß, Wittchen, Zaudig \& Houben, 2003).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
858
iCHIMPS is an online intervention. In terms of content, iCHIMPS is based on the CHIMPS program as well as on other evidence-based interventions of the study group. iCHIMPS will also be comprised of one module for children and adolescents as well as one module for parents; moreover; modules for the family system will be included.
Mental health of the parents (BSI)
Mental health of the parents, assessed from the perspective of the parents by the "Brief Symptom Inventory" (BSI; Franke, 2000).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Mental health of the parents (PHQ)
Mental health of the parents, Mental health of the parents, assessed from the perspective of the parents by the "Patient Health Questionnaire" (PHQ; PHQ; Löwe, Spitzer, Zipfel \& Herzog, 2002).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Mental health of the parents (GAF)
Mental health of the parents, assessed from the perspective of an external rater by the "Global Assessment of Functioning" (GAF; Saß, Wittchen, Zaudig \& Houben, 2003).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
General anxiety of the parents (GAD-7)
General anxiety of the parents, assessed from the perspective of the parents by the "Gerneralized Anxiety Disorder-7" (GAD-7; Kroenke, Spitzer, Williams, Monahan, \& Löwe, 2007).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Health-related quality of life of the parents (SF-12)
Health-related quality of life of the parents, assessed from the perspective of the parents by the "Short Form 12" (SF-12; Bullinger \& Kirchberger, 1998)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Health-related quality of life of the parents (EQ-5D)
Health-related quality of life of the parents, assessed from the perspective of the parents by the EQ-5D (EQ-5D; Brooks, Rabin \& Charro, 2003; Hinz, Klaiberg, Brahler \& Konig, 2006).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Health-related quality of life of the children and adolescents (KIDSCREEN)
Health-related quality of life of the children and adolescents, assessed from the perspective of the child/adolescent (from 10 years of age) and from the perspective of the parents by the Kidscreen-27 (The KIDSCREEN Group Europe, 2006).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Family functioning (GARF)
Family functioning, assessed from the perspective of an external rater by the "Global Assessment of Relational Functioning" (GARF; Saß, Wittchen, Zaudig \& Houben, 2003).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Family functioning (FB-A)
Family functioning, assessed from the perspective of the parents and the children and adolescents (from 10 years of age) by the "Allgemeiner Familienfragebogen" (FB-A; Cierpka \& Frevert, 1995)
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Social support of the parents (OSSQ)
Social support of the parents, of the children and adolescents, assessed from the perspective of the parents, of the children and adolescents (from 10 years of age) by the "Oslo Social Support Questionnaire" (OSSQ; Dalgard, 2006).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Parental stress coping (EBI)
Parental stress coping, assessed from the perspective of the parents by the "Elterliches Belastungsinventar" (EBI; Tröster, 2010).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Treatment evaluation (FBB)
Treatment evaluation, assessed from the perspective of the parents, the children and adolescents (from 10 years of age) as well as from the therapist by the "Fragebogen zur Behandlungsbeurteilung" (FBB; Mattejat \& Remschmidt, 1999).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Satisfaction with the treatment (ZUF-8)
Satisfaction with the treatment of the parents, of the children and adolescents, assessed from the perspective of the parents and from the perspective of the children/adolescents (from 10 years of age) by the "ZUF-8" (Schmidt, Lamprecht \& Wittmann, 1989).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Therapeutic activity and therapeutic processes (VPPS)
Therapeutic activity and therapeutic processes, assessed from the perspective of the therapist by the "Vergleichende Psychotherapy Prozess Skalen" (VPPS; Beutel et al., 2016).
Time frame: During the intervention
Treatment costs (CAMHSRI-DE)
Treatment costs of the children and adolescents, assessed from the perspective of an external rater by the German version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian, Losert, McDaid, Park, Knapp, Beecham, Kusakovskaja, Murauskiene \& the CAMHEE Project, 2009).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Treatment costs (CSSRI-DE)
Treatment costs of the parents, assessed from the perspective of an external rater by the German version of the "Client Socioeconomic and Services Receipt Inventory" (CSSRI-DE; Roick, Kilian, Matschinger, Bernert, Mory \& Angermeyer, 2001).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Family-oriented attitude (FFMHPQ)
Family-oriented attitude, assessed from the clinical employee's point of view by the German version of the "Family Focused Mental Health Practice Questionnaire" (FFMHPQ, Laser et al., 2019).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Implementation components (ICQ)
Implementation components, assessed from the clinical employee's point of view by the German version of the "Implementation Components Questionnaire" (ICQ, Laser, Skogøy, Maybery \& Wiegand-Grefe, 2019).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization
Implementation Satisfaction (ISS)
Implementation Satisfaction, assessed from the clinical employee's point of view by the German version of the "Implementation Satisfaction Scale" (ISS, Laser, Skogøy, Maybery \& Wiegand-Grefe, 2019).
Time frame: Change from baseline of the study at 6,12 and 18 months after the randomization