The primary aim of our study will be to investigate the effectiveness of PCIT in comparison with methylphenidate in children with ADHD and disruptive behavior problems aged 2;6 till 6 years who have not responded sufficiently to previously offered…
ID
Source
Brief title
Study of Treatment of ADHD and behavior problems in Preschool
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of treatments will be the primary caretaker*s Eyberg Child
Behavior Inventory (ECBI). This is a widely used parent rating scale designed
to measure conduct problem behavior in children between the ages of 2 and 16
years. Parents indicate the presence of problem behaviors at a 7 point Likert
type rating scale. They also state whether or not each behavior forms a problem
for them.
Secondary outcome
As secondary objective we try to identify relevant predictors and moderators of
treatment response, which include both parental factors and children*s
characteristics. Furthermore, we will investigate the effects of both
treatments on a number of secondary outcome measures such as the secondary
caretaker*s ECBI scores, parent reported internalizing symptoms and symptoms of
ADHD, parenting practices, stress, and sense of competence, teacher reported
conduct problem behaviors and internalizing symptoms, and functional impairment
as assessed by parents, teachers, and clinicians. A final secondary aim is to
investigate long-term effects, after up to 24 months.
Background summary
Attention Deficit Hyperactivity Disorder (ADHD) and disruptive behavior 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.
Although Parent Management Training (PMT) is an effective treatment for
behavior problems in preschool children, a subgroup of children does not
respond sufficiently to this treatment. Our hypothesis is that treatment
through Parent Child Interaction Therapy (PCIT) gives better results than
treatment with methylphenidate because the effect sizes of treatment with
methylphenidate as found in the PATS study (Greenhill e.a, 2006) have been
lower than those achieved through treatment with PCIT (Thomas & Zimmer-Gembeck,
2007)
Study objective
The primary aim of our study will be to investigate the effectiveness of PCIT
in comparison with methylphenidate in children with ADHD and disruptive
behavior problems aged 2;6 till 6 years who have not responded sufficiently to
previously offered PMT. As secondary objective we aim to identify predictors
and moderators of treatment response, which include both parental and
children*s characteristics.
Study design
The research project involves a randomized controlled trial. Eligible children
will be randomly assigned to either PCIT or to the most optimal dose of
methylphenidate, as determined through placebo-controlled cross-over trials
with low and high doses.
Intervention
In PCIT, parents are taught specific skills to establish a nurturing and secure
relationship with their child while increasing their child*s prosocial behavior
and decreasing negative behavior. Treatment with methylphenidate is aimed at
reducing hyperactivity and impulsive behaviors.
Study burden and risks
The protocol involves a therapeutic study in minors. Participating children can
benefit from study participation in that they may improve through treatments
that are not provided in regular care. Study participation involves no extra
burden for the study subjects, i.e. the children, apart from possible side
effects through methylphenidate, which are reversible. Parents, however, are
asked to complete a set of questionnaires at regular time points.
Postbus 660
9700 AR Groningen
NL
Postbus 660
9700 AR Groningen
NL
Listed location countries
Age
Inclusion criteria
1. 1. Children of both sexes, of any ethnic and cultural background, ages 2;6 to 6 years.
2. At time of referral A DSM-IV (American Psychiatric Association, 1994) consensus diagnosis of ADHD any subtype including ADHD-Not Otherwise Specified.
3. At time of referral presence of oppositional behavior as evidenced through either a DSM-IV (American Psychiatric Association, 1994) consensus diagnosis of ODD, or Conduct Disorder, or Disruptive Behavior Disorder Not Otherwise Specified, or a baseline primary caretakers ECBI score >= 131 and identification of minimally three target problem behaviors.
4. Previous treatment through PMT has resulted in less than 30% reduction on the primary caretaker ECBI score, or on the Externalizing scale of the C-TRF/1*-5 or has resulted in a rating of less than improved on the Clinical Global Impression Scale of improvement by the clinician.
5. Full Scale IQ equivalent of >70.
6. The same primary caretaker for at least 6 months before inclusion.
7. Parents have provided informed consent to participate in the study, in accordance with Dutch ethical regulations.
8. Systolic and diastolic blood pressure below 95th percentile for age and gender.
Exclusion criteria
1. 1. Previous PCIT; other forms of previous treatments are acceptable, including the use of previous psychotropic medication.
2. The child has a major medical condition that would interfere with involvement in a long-term study or could be affected negatively by methylphenidate, including the presence of schizophrenia, hyperthyroidism, cardiac arrhythmias, angina pectoris, and glaucoma.
3. Ongoing psychosocial treatment or ongoing treatment with psychotropic medication.
4. Inability of the parent to understand or follow study instructions.
5. Patients whose families anticipate a move outside the geographic range of the investigative site.
6. Use of any other psychotropic medication or has taken an investigational drug in the past 30 days.
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-019930-28-NL |
| CCMO | NL31116.042.10 |
| OMON | NL-OMON29136 |