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. - STAP

• Conditions: ADHDODD; MedDRA version: 12.1Level: LLTClassification code 10064104Term: ADHD

• Registration Number: EUCTR2010-019930-28-NL
• Lead Sponsor: Accare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Children of both sexes, of any ethnic and cultural background, ages 2;6 to 5;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 mother’s ECBI score > 114 and identification of minimally three target problem behaviors.
4.Previous treatment through PMT has resulted in less than 30% reduction on the ECBI, or on the Externalizing scale of the Teacher Report Form for Ages 1½-5 (TRF/1½-5) or has resulted in a rating of less than improved on the Clinical Global Impression Scale of improvement by at least two of the three raters (parent, teacher, or 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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.
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 or who plan extended travel inconsistent with the recommended visit intervals.
6.Use of any other psychotropic medication or has taken an investigational drug in the past 30 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified