Attention Deficit-/Hyperactivity Disorder
Conditions
Keywords
Attention deficit-/hyperactivity disorder, parenting enhancement training, guided self-help, methylphenidate
Brief summary
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.
Detailed description
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) already medicated with methylphenidate (MPH). This particular PET was developed at the Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne and has already been evaluated in several studies. MPH treatment has been proven to be efficacious in the reduction of ADHD symptoms. However, despite optimal titration a substantial percentage of children still suffer from residual symptoms and impairment in psychosocial functioning. Therefore, there is still room for improvement in satisfaction with medication. Moreover, a substantial rate of patients with good treatment effects fails to comply with medication during the course of treatment. This parenting enhancement training (PET) mainly conducted via written materials and telephone support will be introduced in patients already treated with MPH. Effects are expected on symptoms of ADHD as well as on comorbid oppositional symptoms. Further outcome parameters are satisfaction with medication and medication compliance of MPH treatment, psychosocial functioning as well as parenting skills. Parenting skills are a main focus of the PET and ADHD symptoms shall be improved through improving parenting skills. Besides focusing on symptoms, recent research often focuses on improvement of quality of life and impairment in psychosocial functioning (e. g. family, school, leisure time) as well. Not only suffer patients from the main symptoms. Many patients suffer as well from the symptoms' consequences, which is often an overall impairment. Satisfaction with medication and medication compliance are fundamental conditions for the success of a long term medical therapy. However, many studies show a lack of compliance.
Interventions
BEHAVIORALEnhancement with psychosocial intervention
Sponsors
Shire
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating | baseline, six months, 12 months; 16 months (control group) | The WFIRS-P is used for the assessment of psychosocial functioning of children diagnosed with ADHD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent rating | baseline, six months, 12 months; 16 months (control group) | 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. |
| Change in Individual Problem Checklist (IPC), parent rating | baseline, six months, 12 months; 16 months | The IPC assesses individual problems as defined together with the parents. It represents the individual problems which were aimed to reduce with the treatment. |
| Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating | baseline, six months, 12 months; 16 months (control group) | The FBB-ADHS is used to assess symptoms of ADHD according to DSM-IV and ICD-10 rated by a parent. |
| Change in Compliance Scale, parent rating | baseline, six months, 12 months; 16 months (control group) | Newly developed parent questionnaire consisting of five items to assess the medication compliance of the patient |
| Questionnaire to assess adverse effects of medication, taken from the Day Profile of ADHD Symptoms (DAYAS) | baseline, six months, 12 months; 16 months (control group) | Subscale of the Day Profile of ADHD Symptoms (DAYAS) which assesses in 11 items the most frequent side effects of ADHD medication |
| Change in Satisfaction with Medication Scale (SAMS), parent rating | baseline, six months, 12 months; 16 months (control group) | The SAMS is used to assess parents' satisfaction with the medication of their child as well as with the effects of medication. |
Countries
Germany
Outcome results
None listed