|- candidate number||9416|
|- NTR Number||NTR2888|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-mei-2011|
|- Secondary IDs||120620024 / 2009.200; ZonMw / METC|
|- Public Title||The STERK-study for offspring: Screening and Training, Enhancing Resilience in Kids.|
|- Scientific Title||Preventing mood and anxiety disorders in youth: A multicentre prevention trial in the high risk offspring of depressed and anxious patients.|
|- hypothesis||1. The STERK-intervention will prevent early onset of anxiety and mood disorders in offspring (compared to a minimal information condition);|
2. The STERK-intervention is cost-effective;
3. The effectiveness of the STERK-training will be influenced by several factors, such as the severity of the parental symptoms (past and current), self-associations, optimism/pessimism, and the parent-child relationship.
|- Healt Condition(s) or Problem(s) studied||Depression, Anxiety disorders, Prevention, Children, Adolescents, Exercise, Risc, Mood disorders, Resilience|
|- Inclusion criteria||1. Aged 8-17 years;|
2. Parent with primary anxiety or mood disorder (current or past, with a history of treatment).
Inclusion for the intervention phase:
Subthreshold anxiety or mood symptomatology OR meeting criteria for the High Risk Index (female, both parents with disorder, past of suicidal behaviour in a parent).
|- Exclusion criteria||1. Psychosis in parent;|
2. Severe substance misuse in parent;
3. Current mental disorder in the child that requires an intervention.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2010|
|- planned closingdate||1-apr-2014|
|- Target number of participants||204|
|- Interventions||1. STERK-training, a 10-session individual behavioural training + 2 parent sessions (themes: behavioral activation, exposure, social network, positive emotions, situations and personality traits, resilience);|
2. Minimal information on paper.
|- Primary outcome||Time to onset of depression or anxiety disorders in the offspring (based on the structured interview iDISC).|
|- Secondary outcome||1. Number of days with depression or anxiety (iDISC);|
2. Child (RCADS) and parent (IDS, BAI) symptoms;
3. Quality of life (EQ5D);
4. Costs (economic evaluation).
|- Timepoints||1. Screening (T0);|
2. Pre-training (T1);
3. Post-training (T2, 4 months after T1);
4. Follow-up 1 (T3, 12 months after T1);
5. Follow-up 2 (T4, 24 months after T1).
|- Trial web site||www.sterkonderzoek.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||dr. M.H. Nauta|
|- CONTACT for SCIENTIFIC QUERIES||dr. M.H. Nauta|
|- Sponsor/Initiator ||University of Groningen (RuG), department of Clinical and Developmental Psychology , Accare, Division University Center for Child and Adolescent Psychiatry, Leiden University Medical Center (LUMC), PsyQ/Mondriaan, GGZ|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The present study investigates whether a 10-session CBT program can postpone or prevent the onset of mood or anxiety disorders in a sample of 204 children (aged 8-17 years) of parents who are or have been treated for anxiety or mood disorders. Anxiety and mood disorders are highly prevalent and pose a huge burden on patients. Their offspring is at increased risk for developing these disorders as well, and we have recently developed a High Risk Index that enables us to select ultra high risk children within his population. The current study qualifies for both a selected (offspring of anxiety and mood disordered patients with the additional risk factors) and an indicated (elevated symptoms) prevention program.
Offspring of anxious or depressed patients (aged 8-17 years; N=204) with an ultra high risk are selected for participation in the intervention trial. These children report sub-threshold symptoms and / or meet two of three criteria for the High Risk Index (female gender, both parents affected, history of a parental suicide (attempt)). All parents receive care as usual for their emotional disorder. Children are randomised to one of two treatment conditions, namely (a) 10 weekly individual child CBT sessions and 2 parent sessions) or (b) Minimal information. Assessments are held at pre-test, post-test and at 12 and 24 months follow-up. Primary outcome is the time to onset of depression or anxiety disorders in the offspring. Secondary outcome measures include number of days with depression or anxiety, child and parent symptoms, quality of life, and cost-effectiveness. In line with models on aetiology of mood and anxiety disorders as well as mechanisms of change during interventions, we selected possible moderators of treatment outcome, namely coping, parent-child interaction, self-associations, optimism/pessimism, temperament, and emotion processing.|
|- Main changes (audit trail)|
|- RECORD||6-mei-2011 - 18-mei-2011|