NL-OMON36319
Completed
Phase 4
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 Study of Treatment of ADHD and behavior problems in Preschool
Accare0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Disruptive behavior/ ADHD
- Sponsor
- Accare
- Enrollment
- 60
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, Not Recruiting
N/A
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. - STAPADHDODDMedDRA version: 12.1Level: LLTClassification code 10064104Term: ADHDEUCTR2010-019930-28-NLAccare60
Not Yet Recruiting
N/A
parent-child interaction therapyAffective disorder.Persistent mood [affective] disordersIRCT20150503022061N1Shahid Beheshti University of Medical Sciences45
Recruiting
N/A
Parent Child Interaction Therapy versus methylphenidate in preschool ADHD.ADHD and behavior problems in preschool children.ADHD en gedragsproblemen bij peuters en kleuters.NL-OMON29136Accare, Division University Medical center for Child and Adolescent Psychiatry, Groningen, The Netherlands.60
Completed
N/A
The beneficial effects of parent-child interactions using dish-washing on communication and mental health.JPRN-UMIN000019169Institute of Development, Aging and Cancer, Tohoku University60
Completed
N/A
Effectiveness of Parent-Child Interaction Therapy on attention deficit hyperactivity disorderIRCT20160530028182N12Sanandaj University of Medical Sciences120