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临床试验/NCT04369625
NCT04369625已完成不适用

Cross-sector Care for Children and Adolescents With Mentally Ill and Addicted Parents - Children of Mentally Ill Parents -Network - CHIMPS-NET

Silke Wiegand-Grefe, Prof. Dr.3 个研究点 分布在 1 个国家目标入组 406 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
406
试验地点
3
主要终点
Children's and adolescent's psychiatric symptomatology (CBCL)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Single (Investigator)

盲法说明

Assessors are blind regarding the randomization (group affiliation) of the families.

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

CHIMPS-T

Experimental

(Children of mentally ill parents) is a family-oriented lowfrequency brief therapy for diagnosis and treatment of mental disorders in children and adolescents. CHIMPS-T is based on a theory model, needs analyses and the pioneering studies of Williams Beardslee. The CHIMPS approach was tested, evaluated and manualized in an initial project (2007-2011).

干预措施: CHIMPS-T (Behavioral)

CHIMPS-P

Experimental

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 sessions will be carried out by a social worker (based on the Finnish model "Let's talk about children (Solantaus), but in a family setting "Let's talk WITH children").

干预措施: CHIMPS-P (Behavioral)

The CHIMPS-MFT-group

Experimental

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: preliminary talk, one additional session with the family (if needed), multifamily group with three to six other families, concluding session.

干预措施: CHIMPS-MFT-group (Behavioral)

iCHIMPS

Experimental

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. Overall, 8 consecutive online modules as well as elective modules will be included. These modules (e.g., dealing with difficult situations, emotion regulation, taboos and shame, self-worth) will be provided based on the specific constellation of children and adolescents of mentally ill parents. iCHIMPS will be completed by 2 booster session within a six months follow-up.

干预措施: iCHIMPS (Behavioral)

Treatment as usual

No Intervention

The treatment as usual implies that families of the control group receive the treatment that is customary in regular care. Thus, these families normally don't receive any post-treatment. If, however, a member of a control group family appears to have an urgent need for treatment (every family receives a comprehensive diagnostic investigation at the beginning of the study), the respective family will be placed in the ambulatory care system.

结局指标

主要结局

Children's and adolescent's psychiatric symptomatology (CBCL)

时间窗: 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).

次要结局

  • 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)

研究者

发起方
Silke Wiegand-Grefe, Prof. Dr.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Silke Wiegand-Grefe, Prof. Dr.

Prof. Dr.

Universitätsklinikum Hamburg-Eppendorf

研究点 (3)

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