The effectiveness of Parent-Child Interaction Therapy versus methylphenidate in preschool children with ADHD and disruptive behavior problems with insufficient improvement through Parent Management Training.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of treatments will be the primary caretaker*s Eyberg Child<br /><br>Behavior Inventory (ECBI). This is a widely used parent rating scale designed<br /><br>to measure conduct problem behavior in children between the ages of 2 and 16<br /><br>years. Parents indicate the presence of problem behaviors at a 7 point Likert<br /><br>type rating scale. They also state whether or not each behavior forms a problem<br /><br>for them.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>As secondary objective we try to identify relevant predictors and moderators of<br /><br>treatment response, which include both parental factors and childrens<br /><br>characteristics. Furthermore, we will investigate the effects of both<br /><br>treatments on a number of secondary outcome measures such as the secondary<br /><br>caretakers ECBI scores, parent reported internalizing symptoms and symptoms of<br /><br>ADHD, parenting practices, stress, and sense of competence, teacher reported<br /><br>conduct problem behaviors and internalizing symptoms, and functional impairment<br /><br>as assessed by parents, teachers, and clinicians. A final secondary aim is to<br /><br>investigate long-term effects, after up to 24 months. </p><br>