CompletedNot Applicable

Implementation and Evaluation of a Family-based Intervention Program for Children of Mentally Ill Parents

Germany, Switzerland400 participantsStarted 2014-11

Plain-language summary

In order to identify psychological stress in children and adolescents of mentally ill parents as early as possible, a special intervention program (CHIMPs = Children of mentally ill parents) was developed. The study at hand will implement this intervention program at five sites in Germany and will further evaluate its effectiveness. The CHIMPs intervention is assumed to reduce children's psychopathology and enhance their health related quality of life.

Who can participate

Age range

3 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Family with at least one psychiatrically ill parent and at least one child between the age of 3 and 19 years * Consent to participate in the study * Sufficient knowledge of the German language of parents and children Exclusion Criteria: * Severe psychiatric disorders and impairments with acute symptoms such as suicidal tendencies, massive self-injurious behaviour, acute psychotic symptoms etc., making a stationary treatment inevitable and making a ambulatory intervention appear contraindicated (These patients are placed in stationary treatment) * Children with severe symptoms in the control group will be placed at a participating psychotherapist. Nevertheless, they stay in the control group (as TAU).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

children's psychiatric symptomatology (Kiddie-SADS interview)

Timeframe: at the beginning of the study (on study enrolment)

children's psychiatric symptomatology (Child behaviour checklist)

Timeframe: at the beginning of the study (on study enrolment)

children's psychiatric symptomatology (assessed by Youth Self Report)

Timeframe: at the beginning of the study (on study enrolment)

children's psychiatric symptomatology (assessed by the SGKJ)

Timeframe: at the beginning of the study (on study enrolment)

children's psychiatric symptomatology (Kiddie-SADS interview)

Timeframe: after the treatment (after 6 months)

children's psychiatric symptomatology (Kiddie-SADS interview)

Timeframe: after the follow-up period (after 18 months)

children's psychiatric symptomatology (Child behaviour checklist)

Trial details

NCT IDNCT02308462

SponsorSilke Wiegand-Grefe, Prof. Dr.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06

View on ClinicalTrials.gov More Schizophrenia and Disorders With Psychotic Features trials