Cross-sector Care for Children and Adolescents With Mentally Ill and Addicted Parents - Children of Mentally Ill Parents -Network - CHIMPS-NET
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mental Health Issue
- Sponsor
- Silke Wiegand-Grefe, Prof. Dr.
- Enrollment
- 858
- Locations
- 1
- Primary Endpoint
- Children's and adolescent's psychiatric symptomatology (CBCL)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Silke Wiegand-Grefe, Prof. Dr.
Prof. Dr.
Universitätsklinikum Hamburg-Eppendorf
Eligibility Criteria
Inclusion Criteria
- •Familiy with at least one psychiatrically ill parent (all F-diagnoses in ICD-10) and at least one child between the age of 3 and 18 years.
- •Consent to participate in the study.
- •Sufficient knowledge of the German language of parents and children.
- •Consent to data processing of the insurance companies, if insured with one of the participating insurance companies.
- •Consent to participation in special care (in case of interventions).
Exclusion Criteria
- •Severe psychiatric disorders and impairments of parents or children with acute symptoms such as suicidal tendencies, severe depression, addictions, acute psychotic symptoms etc., which will not be sufficiently supplied by these new lowfrequency interventions.
Outcomes
Primary Outcomes
Children's and adolescent's psychiatric symptomatology (CBCL)
Time Frame: Change from baseline of the study at 6,12 and 18 months after the randomization
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).
Secondary Outcomes
- Sociodemographic information(At baseline of the study])
- Psychiatric disorders of the children and adolescents (YSR)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Mental health of the parents (BSI)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Psychiatric symptomatology of the children and adolescents (GAF)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Mental health of the parents (GAF)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- General anxiety of the parents (GAD-7)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Family functioning (GARF)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Family functioning (FB-A)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Therapeutic activity and therapeutic processes (VPPS)(During the intervention)
- Treatment costs (CAMHSRI-DE)(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)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Treatment evaluation (FBB)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Mental health of the parents (PHQ)(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)(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)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Treatment costs (CSSRI-DE)(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)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Social support of the parents (OSSQ)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Parental stress coping (EBI)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Satisfaction with the treatment (ZUF-8)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Implementation components (ICQ)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Implementation Satisfaction (ISS)(Change from baseline of the study at 6,12 and 18 months after the randomization)
- Family-oriented attitude (FFMHPQ)(Change from baseline of the study at 6,12 and 18 months after the randomization)