Primary objective:To investigate the efficacy of a 12-week group-based training for female adolescents with CD (DBT-CD-A) compared to treatment as usual (TAU) within youth welfare institutions. It is hypothesised that add-on highly structured DBT-CD…
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main purpose of the current study is to investigate the efficacy of a
12-week group based DBT-CD-A training for female adolescents with CD compared
to treatment as usual (TAU) within youth welfare institutions.
Primary endpoints: Response to intervention: pre-post treatment change in
number of fulfilled CD/ODD diagnostic criteria
Secondary outcome
Further objectives of the current trial are to assess pre-post change in
CD-related outcome measures after the 12-week group based DBT-CD-A training
compared to TAU. We destinguish between subjective, behavioural and
neurobiological endpoints. I refer to the study protocol for a description of
these endpoints.
Background summary
To date, treatment programs are not widely implemented and evaluated in
adolescence, although adolescence is one of the key periods for intervention
due to the increasing prevalence of CD. In addition, no randomised controlled
trial (RCT) studies have been performed with female adolescents living in the
youth welfare system. Thus, there is an urgent need to study new promising
psychotherapeutic intervention approaches for CD, especially in female
adolescents.
Study objective
Primary objective:
To investigate the efficacy of a 12-week group-based training for female
adolescents with CD (DBT-CD-A) compared to treatment as usual (TAU) within
youth welfare institutions. It is hypothesised that add-on highly structured
DBT-CD-A training will result in improved emotion regulation skills and thus in
overall CD symptom reduction, as compared to TAU (including no group
intervention).
Secondary objectives:
To assess pre-post change in CD-related outcome measures after a 12-week
DBT-CD-A group based training for female adolescents with CD compared to TAU
within youth welfare institutions; to investigate behavioural and
neurobiological predictors of treatment success; and to delineate mechanisms of
change in DBT-CD-A in a pre-mid-post treatment design.
Study design
Prospective, confirmatory, cluster-randomised, parallel group, multi-centre and
international phase III-trial.
Intervention
START NOW is a group based 12-week intervention in which several
psychotherapeutic approaches are combined (CBT+DBT+mindfulness+trauma sensitive
care). It aims to reduce behavioural problems and to improve emotion regulation
in adolescent girls.
Study burden and risks
Direct benefits resulting from study participation includes: expected
therapeutic benefit from a cognitive-behavioural group training program/
symptom reduction; reduced stress, enhanced self-efficacy and enhanced
psychosocial adjustment. No risk for severe injury is associated with
participation in this study. Participants might experience fatigue caused by
the study protocol. We will monitor the well being of our participants any
time, and will insert brakes whenever necessary. Participation in the
brainimaging protocol can cause stress for the participant. Only those
participants who feel totally comfortable with a visit to the MRI scan will
participate in this part of the study.
Rijksstraatweg 145
Duivendrecht 1115 AP
NL
Rijksstraatweg 145
Duivendrecht 1115 AP
NL
Listed location countries
Age
Inclusion criteria
- Female sex
- age 13 - 20 years
- Diagnosis of Conduct Disorder within the 12 months prior to institutionalisation OR current diagnosis Oppositional Defiant Disorder and lifetime CD
- sufficient writing and reading skills (Dutch)
Exclusion criteria
- History of or current clinical diagnosis of autism spectrum disorder
- History of or current clinical diagnosis of schizophrenia
- Current clinical diagnosis of Bipolar Disorder or Mania
- Fetal Alcohol Syndrome
- Known monogenetic disorder or genetic syndrome
- Any chronic or acute neurological disorder
- IQ < 70
- severe medical condition interfering with therapy
- concurrent group based psychotherapy
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 | NL52038.029.14 |