Oppositional Defiant Disorder (ODD)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Treatment naïve. 2. Children of both sexes, of any ethnic and cultural background, ages 2.5 to 6 years. 3. A DSM-IV (American Psychiatric Association, 1994) consensus diagnosis of ADHD combined or predominantly hyperactive subtype. 4. A DSM-IV (American Psychiatric Association, 1994) consensus diagnosis of ODD. 5. An impairment scale score 70. 7. The same primary caretaker for at least 6 months before screening. 8. Parents have provided informed consent to participate in the study, in accordance with Dutch ethical regulations.
Exclusion criteria
Exclusion criteria: 1. There is current evidence in the child of adjustment disorder, autistic disorder, psychosis, or other psychiatric disorder in addition to ADHD that requires treatment with additional medication. 2. The child has a major medical condition that would interfere with involvement in a long-term study 3. Inability of the parent to understand or follow study instructions. 4. History of bipolar disorder in both biological parents. 5. Patients whose families anticipate a move outside the geographic range of the investigative site or who plan extended travel inconsistent with the recommended visit interval
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the mothers* Eyberg Child Behavior Inventory (ECBI). | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify predictors and moderators of treatment response, which includes both parent (presence of psychiatric problems, socio-economic status, and parental stress associated with rearing) and children*s characteristics (children's age, intelligence, range of co morbidities, and genetic polymorphisms). | — |
Countries
Netherlands