Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhancement of Psychosocial Functioning, Quality of Life, Satisfaction With Medication and Medication Compliance of Methylphenidate Treatment by Psychosocial Intervention and Support

Conditions
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Attention Deficit-/Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Enhancement with psychosocial intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: treatment as usual with MPH<br>In the first twelve months of intervention the children receive treatment as usual with MPH and do not get any further intervention. Afterwards, the families get the opportunity to take part in the program which is then conducted for a duration of four months. Measurements are performed at the beginning of the program, after six moths, after 12 months and additionally after 16 months. | |
| Active Comparator: Psychosocial intervention<br>Parenting Enhancement Training as a form of psychosocial intervention is a guided program. Parents get the opportunity to discuss written information with a therapist in 20 minutes telephone calls. 14 telephone calls are offered. The whole intervention lasts for a period of one year. Booklets are mailed via post within the first 4 months. First 9 telephone calls are also within the first 4 months, usually every two weeks. Telephone calls 10 and 11 are within 5th or 6th month, telephone calls 12 to 14 are within 7th to 12th month with a two monthly time period in between. | Behavioral: Enhancement with psychosocial intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention deficit-/hyperactivity disorder, parenting enhancement training, guided self-help, methylphenidate