The primary objective is to investigate whether a brief (10+2 sessions) Cognitive Behavioural Therapy (CBT) program can (postpone or) prevent the onset of depression or anxiety disorder in an ultra high risk sample of 8-18 year old children of…
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
depressieve symptomen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the time to onset of depression or anxiety disorder in the
offspring.
Secondary outcome
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 mediators of treatment
outcome, namely attribution style, coping, parent-child interaction and
attachment, personality, optimism and self-esteem.
Background summary
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.
Study objective
The primary objective is to investigate whether a brief (10+2 sessions)
Cognitive Behavioural Therapy (CBT) program can (postpone or) prevent the onset
of depression or anxiety disorder in an ultra high risk sample of 8-18 year old
children of parents who are currently being treated for depression or anxiety
disorder. The second goal is to examine whether this intervention meets current
standards for cost-effectiveness. A third goal is to explore the role of a
number of factors that may potentially mediate or moderate the effect of the
intervention.
Study design
Randomized Controlled Trial (RCT). 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.
Assessments are held at baseline, after the intervention or control period and
at 12 and 24 months follow-up.
Intervention
Children are randomized to one of two treatment conditions, namely
(a) 10 weekly individual child CBT sessions and 2 parent sessions. The
following themes will be addressed: emphasizing the child*s positive features
(strengths, characteristics, positive events and emotions), family and social
functioning / social network, activation, and breaking the cycle of avoidance
behaviour)
(b) Minimal information.
Study burden and risks
The present study concerns indicated and selective prevention. The study
population consists of high-risk, but healthy children. The study in itself is
not expected to enhance the children*s possible risk; on the contrary, it is
expected to decrease that risk. Burden might consist of the time asked from
parents and child. Estimated time consumed is one morning per participant per
assessment (plus one morning extra at T1 for one parent). Furthermore, the
intervention group is asked to attend a weekly 12 session training of 45
minutes a week. Parents are asked to participate twice. Benefits of the
present study are the frequent screening of all high-risk children
participating in the study. Regardless randomization, all screened high-risk
children will be included in the assessment program. In case of a possible
onset of a clinical disorder, this will therefore be detected sooner than
usual, and can be treated sooner.
Grote Kruisstraat 2/1
9712 TS Groningen
NL
Grote Kruisstraat 2/1
9712 TS Groningen
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria (parents): at least one of the biological parents is currently being treated for a depression (MDD, dysthymia) or an anxiety disorder (Social phobia SocP, Agoraphobia AP, Panic disorder PD, Generalized anxiety disorder GAD, Separation anxiety disorder SAD); informed consent.
Inclusion criteria (offspring): age 8-18; being at risk for developing a depression or anxiety disorder, defined as meeting at least 2 of the 3 criteria of the High Risk Index (risk factors: female sex, 2 affected parents, suicide attempt of one of the parents; see Ch. 1) or reporting subthreshold symptoms of anxiety or depression, defined as scoring above the 80th percentile of the RCADS questionnaire (we chose a relatively high cutoff value for the RCADS, to enhance specificity); informed consent.
Exclusion criteria
Exclusion criteria (both parents): mental retardation; index parent is not fluent in Dutch; severe alcohol or substance use disorder; schizophrenia or other primary psychotic disorder; schizoaffective disorder; bipolar disorder BPD, Obsessive-compulsive disorder OCD, PTSD, only simple phobia SP.
Exclusion criteria (offspring): mental retardation; not speaking Dutch fluently; severe alcohol or substance use disorder; current diagnosis of MDD, dysthymia, SocP, AP, PD, GAD, BPD, PTSD, OCD, SP; previous or current treatment for a DSM-IV psychiatric disorder.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21730.042.09 |