The aim of the study is to investigate the neurobiology of Conduct Disorder (CD) in female and male children and adolescents, and examine for sex differences in the phenotype (clinical presentation) of CD, and the relationships between CD and…
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Autonomic Nervous System activity: heart rate, heart rate variability,
respiratory sinus arrhythmia, pre-ejection period, and skin conductance level
in rest and during reactivity to emotionally arousing stimuli
• Neuroendocrinology: basal levels of cortisol, testosterone,
dehydroepiandrosterone sulfate (DHEA-S), alpha-amylase, progesterone,
estradiol, oxytocin, and Vasopressin (AVP). And reactivity to a social stressor
of cortisol and testosterone.
Secondary outcome
• Psychiatric disorders
• Psychopathic traits
• Intelligence
• Reactive and proactive aggression
• Parenting behavior
• Emotion Regulation
• Empathy
• Pubertal development
• Callous-Unemotional traits
• Socio-demographic factors
• Medication and drug use
• Brain structure and functioning
Background summary
Antisocial behaviour is a major public health problem. Children and adolescents
with persistent and severe antisocial behaviour, which in psychiatry is
referred to as Conduct Disorder, have a poor prognosis with negative adult
outcomes that frequently include criminality, alcohol and substance abuse,
unemployment, and poor mental and physical health. The number of females
exhibiting serious aggressive behaviours has increased over the last tow
decades. The majority of studies examining the etiology and neurobiology of
Conduct Disorder, have focused on male subject only. This means that we know
far less about the development, risk factors and treatment of Conduct Disorder
in females.
Study objective
The aim of the study is to investigate the neurobiology of Conduct Disorder
(CD) in female and male children and adolescents, and examine for sex
differences in the phenotype (clinical presentation) of CD, and the
relationships between CD and changes in brain structure and function, stress
and sex hormone concentrations, neuropsychological performance,
psychophysiological activity, and molecular genetic and epigenetic markers. A
broad age range is used to study these factors from pre- to postpuberty and
study it's association with persistence and desistance.
Study design
This study comprises a cross sectional study, a longitudinal study and an RCT,
executed in eight different European countries. We aim to study 1840 male and
female adolescents in total.
Questionnaires, a semi-structured interview, neuropsychological tasks,
psychophysiological and neuroendocrinological measurements, and a brain imaging
protocol will be applied to study:
- The neurobiological correlates of female CD, instrumental/proactive
aggression and reactive aggression
- Neurobiological measures as predictors of persistence versus remission from CD
- The effects of puberty on these measures in females and the impact of early
versus on-time or late puberty on these measures in relation to CD, emotion
processing, reactive- and proactive aggression.
Intervention
To date, treatment programs are not widely implemented and evaluated in middle
childhood and adolescence, although adolescence is one of the key periods for
intervening, most notably in CD girls due to their late onset. To date, there
is an internationally recognized lack of randomised controlled trials (RCTs)
demonstrating efficacy of new and promising interventions in female adolescents
with CD. Thus, there is a strong need for RCTs investigating innovative
intervention approaches for CD, especially in female adolescents.
The implementation of a dialectical-behavioural treatment program for female
adolescents with conduct disorder (DBT-CD-A, publication name: START NOW)
profoundly gives consideration to the repeatedly formulated necessity to
develop integrative intervention approaches deriving from sound theoretical
rationales, addressing core deficits of CD patients and applying gender
specific strategies and materials (see State-of the Science Statements of the
National Institutes of Health, NIH, 2004).
The planned RCT will for the first time systematically investigate the efficacy
of a group-based DBT approach aiming at enhancing emotion regulation and
emotion recognition in female CD patients. Within the Netherlands 30 CD-girls
within the age range 13-18 years old, will participate in the RCT.
START NOW consists of 12 weekly group and individual sessions. Each session
focuses on a specific topic and specific skills are taught during each session.
START NOW is provided by two specifically trained social workers. Once every
two weeks supervision is provided for these trainers. To improve their
trainers skills and to ensure treatment adherence.
Study burden and risks
There are no risks associated with participation in this study. Several
questionnaires and an interview might, in very few cases, cause discomfort.
However, a researcher will always be present and will be focused on
establishing a confidential and pleasant ambiance for the participant, and will
take away any feelings of discomfort when present.
F.i.; during one of the tasks the participant will be exposed to a loud noise.
The participant will be warned that she will hear the loud noise for 1 second.
The noise might be unpleasant, but will absolutely do no harm to the
participant or his/her hearing.
For another task the participant will watch two short film clips in which a sad
situation is displayed. The movies are suitable for children from the age of 6
years old. After the film clips have been displayed the researcher will come up
to the participant to ask how she feels and to chat a little to bring the
participant into an emotional neutral state.
Several participants will be asked to perform a speech and a mental arrythmic
task. These tasks might cause stress. After completing the tasks the researches
will provide positive feedback only, so the participant will feel comfortable
and appreciated.
The MRI scannen for the brain imaging protocol might cause claustrophobic
experiences to the participant. The participant is constantly monitored by the
researchers and can contact the research anymoment. If the participant shows
any sign of discomfort the brain imaging protocol will be stopped and the
participant will be taken out of the scanner. Before we start the neuroimaging
protocol we will check for claustrophobic experiences and each participant will
do a test-session is a dummy-scanner.
Rijksstraatweg 145
Duivendrecht 1115 AP
NL
Rijksstraatweg 145
Duivendrecht 1115 AP
NL
Listed location countries
Age
Inclusion criteria
- Age: 9-18 years old
- normal or corrected to normal vision and hearing
- good level of Dutch reading and listening
- Diagnostic criteria for CASES:
current diagnosis of Conduct Disorder (CD) OR diagnosis of CD in the past, while currently 'only' two symptoms of Oppositional Defiant Disorder (ODD) are present in combination with one CD symptom.
OR:
- 9-12 year olds: Diagnosis of ODD + (at least) one symptom of CD
- 13-18 year olds: Diagnosis of ODD + (at least) two symptoms of CD;- Diagnostic criteria for controls: no current psychiatric disorder and no history of ADHD, ODD, CD
Exclusion criteria
- formal clinical diagnosis of an autism spectrum disorder or a neurodevelopmental syndrome
- IQ < 70
- Inability to speak or understand Dutch
- being pregnant or having recently given birth (within the last 6 months)
- severe head injury with prolonged loss of consciousness (> 1 hour) or confirmed traumatic brain injury
- severe epilepsy
- exclusion criterion for the control group: any Axis I disorder, or diagnosis of CD, ODD, ADHD in the past
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 | NL47345.029.14 |