To compare the effectiveness of group versus individual parent management training (PMT) in preschool children with disruptive behavior problems and to identify predictors and moderators of treatment response.
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be the mothers* Eyberg Child Behavior
Inventory (ECBI).
Secondary outcome
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).
Background summary
Disruptive behavior problems, i.e., attention-deficit/hyperactivity disorder
(ADHD) and oppositional defiant disorder (ODD) at preschool age forms a major
burden for parents, is associated with a wide range of functional impairments,
and is a risk factor for child maltreatment. They are a well-established risk
factor for future psychiatric problems, educational underachievement, social
isolation, antisocial behavior and alcohol and drugs abuse.
Study objective
To compare the effectiveness of group versus individual parent management
training (PMT) in preschool children with disruptive behavior problems and to
identify predictors and moderators of treatment response.
Study design
Participating patients will be 150 referred treatment naïve preschool children
with disruptive behavior (i.e., fulfilling criteria for ADHD and ODD) and will
be randomly assigned to either group or individually delivered PMT.
Intervention
Group or individually delivered PMT
Study burden and risks
The treatments are routinely given in clinical practice and are as such not
associated with particular risks or benefits. The extra burden for
participating families is limited to completion of a number parent
questionnaires.
Hanzeplein 1
9700 AR Groningen
NL
Hanzeplein 1
9700 AR Groningen
NL
Listed location countries
Age
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 <55 on the Children's Global Assessment Scale (Shaffer et al., 1983).
6. Full Scale IQ equivalent of >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
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
Recruitment
Medical products/devices used
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 | NL27754.042.09 |