Attention Deficit-/Hyperactivity Disorder Clinical Trial
Official title:
Enhancement of Psychosocial Functioning, Quality of Life, Satisfaction With Medication and Medication Compliance of Methylphenidate Treatment by Psychosocial Intervention and Support
| Verified date | March 2014 |
| Source | University of Cologne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
The main purpose of this study is to evaluate the effectiveness of a parenting enhancement training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity Disorder (ADHD) who are already medicated with methylphenidate.
| Status | Active, not recruiting |
| Enrollment | 100 |
| Est. completion date | March 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years to 12 Years |
| Eligibility |
Inclusion Criteria: - The child attends school and is aged 6 to 12 - Primary diagnosis of ADHD - Medication with methylphenidate in stable doses for at least two months - Currently, no change of medication is planned - The parents are motivated to participate in the parenting enhancement training - The parents have a command of written and spoken German - Psychosocial impairment measured with WFIRS-P Exclusion criteria: - the family takes presumably part in psychotherapy with an intensive parenting training component during the duration of the intervention |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne | Cologne | NRW |
| Lead Sponsor | Collaborator |
|---|---|
| University of Cologne | Shire |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating | The WFIRS-P is used for the assessment of psychosocial functioning of children diagnosed with ADHD. | baseline, six months, 12 months; 16 months (control group) | No |
| Secondary | Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating | The FBB-ADHS is used to assess symptoms of ADHD according to DSM-IV and ICD-10 rated by a parent. | baseline, six months, 12 months; 16 months (control group) | No |
| Secondary | Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent rating | The Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV) is used to assess symptoms of ODD and some of the symptoms of Conduct Disorders according to ICD-10 and DSM-IV. | baseline, six months, 12 months; 16 months (control group) | No |
| Secondary | Change in Individual Problem Checklist (IPC), parent rating | The IPC assesses individual problems as defined together with the parents. It represents the individual problems which were aimed to reduce with the treatment. | baseline, six months, 12 months; 16 months | No |
| Secondary | Change in Satisfaction with Medication Scale (SAMS), parent rating | The SAMS is used to assess parents' satisfaction with the medication of their child as well as with the effects of medication. | baseline, six months, 12 months; 16 months (control group) | No |
| Secondary | Change in "Compliance Scale", parent rating | Newly developed parent questionnaire consisting of five items to assess the medication compliance of the patient | baseline, six months, 12 months; 16 months (control group) | No |
| Secondary | Questionnaire to assess adverse effects of medication, taken from the Day Profile of ADHD Symptoms (DAYAS) | Subscale of the Day Profile of ADHD Symptoms (DAYAS) which assesses in 11 items the most frequent side effects of ADHD medication | baseline, six months, 12 months; 16 months (control group) | No |