Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support
2014年3月12日 更新者：Manfred Doepfner、University of Cologne
Enhancement of Psychosocial Functioning, Quality of Life, Satisfaction With Medication and Medication Compliance of Methylphenidate Treatment by Psychosocial Intervention and Support
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.
調査の概要
状態
わからない
詳細な説明
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.
研究の種類
介入
入学 (予想される)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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NRW
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Cologne、NRW、ドイツ、50937
- Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
6年～12年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：treatment as usual with MPH
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.
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アクティブコンパレータ：Psychosocial intervention
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating
時間枠：baseline, six months, 12 months; 16 months (control group)
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The WFIRS-P is used for the assessment of psychosocial functioning of children diagnosed with ADHD.
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baseline, six months, 12 months; 16 months (control group)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating
時間枠：baseline, six months, 12 months; 16 months (control group)
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The FBB-ADHS is used to assess symptoms of ADHD according to DSM-IV and ICD-10 rated by a parent.
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baseline, six months, 12 months; 16 months (control group)
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Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent rating
時間枠：baseline, six months, 12 months; 16 months (control group)
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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.
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baseline, six months, 12 months; 16 months (control group)
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Change in Individual Problem Checklist (IPC), parent rating
時間枠：baseline, six months, 12 months; 16 months
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The IPC assesses individual problems as defined together with the parents.
It represents the individual problems which were aimed to reduce with the treatment.
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baseline, six months, 12 months; 16 months
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Change in Satisfaction with Medication Scale (SAMS), parent rating
時間枠：baseline, six months, 12 months; 16 months (control group)
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The SAMS is used to assess parents' satisfaction with the medication of their child as well as with the effects of medication.
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baseline, six months, 12 months; 16 months (control group)
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Change in "Compliance Scale", parent rating
時間枠：baseline, six months, 12 months; 16 months (control group)
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Newly developed parent questionnaire consisting of five items to assess the medication compliance of the patient
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baseline, six months, 12 months; 16 months (control group)
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Questionnaire to assess adverse effects of medication, taken from the Day Profile of ADHD Symptoms (DAYAS)
時間枠：baseline, six months, 12 months; 16 months (control group)
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Subscale of the Day Profile of ADHD Symptoms (DAYAS) which assesses in 11 items the most frequent side effects of ADHD medication
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baseline, six months, 12 months; 16 months (control group)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年5月1日
一次修了 (予想される)
2014年12月1日
研究の完了 (予想される)
2015年3月1日
試験登録日
最初に提出
2012年8月6日
QC基準を満たした最初の提出物
2012年8月7日
最初の投稿 (見積もり)
2012年8月8日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年3月13日
QC基準を満たした最後の更新が送信されました
2014年3月12日
最終確認日
2014年3月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- ADHD-TEAM-02
- 2486738 (その他の助成金/資金番号：Shire pharmaceutical development limited)
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