|- candidate number||6381|
|- NTR Number||NTR1982|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-aug-2009|
|- Secondary IDs||50-50110-96-648 ZonMW|
|- Public Title||(Economic) Evaluation of E-mental Health Interventions for Children of Parents with Mental Illness (e^3 COPMI).|
|- Scientific Title||A trial based economic evaluation of Kopstoring; A study on the costs and effects of an online prevention program for children of 16 to 25 years old of parents with mental or substance use disorders.|
|- ACRONYM||e^3 COPMI|
|- hypothesis||Children of parents with a mental illness or substance use disorder have high elevated risks to develop (mental and behavioural) problems themselves. Hypothesis is that the online Kopstoring intervention will be effective and cost-effective preventing futire problems and illnesses compared to care as usual.|
|- Healt Condition(s) or Problem(s) studied||Mental health problems, Prevention, Substance abuse|
|- Inclusion criteria||The adolescent:|
1. Has to have at least one parent suffering from a mental illness or substance use disorder;
2. Has to be qualified as child who fits the cut-off scores of the Youth Self Report questionnaire. The child has to fit in the scores to the groups that are equivalent to the child barely having symptoms and having medium symptoms;
3. Sufficiently fluent in the Dutch language;
4. Has access to the internet;
5. Ability to use a chat box: able to participate actively and able to listen to other participants;
6. When aged 16-17 years informed consent of both child and parent; when aged 18 and over, informed consent of the adolescent only (mandatory under the Dutch law).
|- Exclusion criteria||1. Children younger that 16 and adults older than 25 years old;|
2. Too heavy symptoms and already developed psychological problems.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2010|
|- planned closingdate||31-dec-2016|
|- Target number of participants||112|
|- Interventions||1. Kopstoring: Online psycho-educative program. The program exists of 8 online sessions over 8 weeks and an evaluation session in a protected chat box (chat room). The aim of the intervention is to strengthen social and emotional functioning, coping skills and the relationship of the child with the parent. This will be achieved by interaction, self-assessments and education;|
2. Care-As-Usual: This will be a “waiting-list control group with unrestricted access to Care-as-Usual”. The Care-As-Usual will consist of preventive CBT sessions in groups under professional guidance, help offered by psychologists, etc, but the choices are not regulated by guidelines and remains the responsibility of the family’s GP. Often, the problems go undetected and the child receives nothing.
|- Primary outcome||For the Effectiveness study and Cost-effectiveness study: Reduction of symptoms and complaints as measured by the Youth Self Report Questionnaire will be used this is a self reported version of Child Behaviour Checklist.
|- Secondary outcome||For the Cost-utility analysis: QALYs and Utilities will be based on the utilities derived from the EuroQol (EQ-5d).
|- Timepoints||1. Baseline;|
2. 8 Weeks;
3. 6 Months;
4. 12 Months.
|- Trial web site||www.kopstoring.nl|
|- CONTACT FOR PUBLIC QUERIES|| Marla Woolderink|
|- CONTACT for SCIENTIFIC QUERIES|| Marla Woolderink|
|- Sponsor/Initiator ||ZonMw: The Netherlands Organization for Health Research and Development|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||DESIGN: We will conduct a pragmatic randomized controlled trial (RCT) in two parallel groups. The Kopstoring program will be compared with a waiting list control condition which reflects Care-As-Usual. The duration of the interventions is 8 weeks and the total time frame of the study will be six months, with a prolonged measurement of outcomes in the intervention group after 12 months. 50% of the participants receive the Kopstoring program; the others receive Care-As-Usual which usually consists of non-standardized care while they are waiting for six months. In the economic evaluations the additional costs and additional outcomes of the Kopstoring will be compared with Care-As-Usual. This economic evaluation will involve a combination of a cost-effectiveness analysis (CEA) and a cost-utility analysis (CUA). In a CEA effects are presented in clinical outcomes, in this case the YSR. The primary outcomes measure for the cost-utility analysis will be Quality Adjusted Life Years (QALYs), based on the EQ-5D utility scores. This economic evaluation will be performed from a societal perspective. |
|- Main changes (audit trail)||23-aug-2016:
- CES-D replaces SCL-90
In-exclusion criteria NEW:
- YSR is no longer a screening method
3. 6 Months;
4. 12 Months.
|- RECORD||31-aug-2009 - 23-aug-2016|