Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support
2014년 3월 12일 업데이트: 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.
연구 개요
상태
알려지지 않은
상세 설명
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.
연구 유형
중재적
등록 (예상)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
NRW
-
Cologne, NRW, 독일, 50937
- Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
6년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 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.
|
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating
기간: 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.
|
baseline, six months, 12 months; 16 months (control group)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating
기간: 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.
|
baseline, six months, 12 months; 16 months (control group)
|
|
Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent rating
기간: 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.
|
baseline, six months, 12 months; 16 months (control group)
|
|
Change in Individual Problem Checklist (IPC), parent rating
기간: 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.
|
baseline, six months, 12 months; 16 months
|
|
Change in Satisfaction with Medication Scale (SAMS), parent rating
기간: 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.
|
baseline, six months, 12 months; 16 months (control group)
|
|
Change in "Compliance Scale", parent rating
기간: 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
|
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)
기간: 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
|
baseline, six months, 12 months; 16 months (control group)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 5월 1일
기본 완료 (예상)
2014년 12월 1일
연구 완료 (예상)
2015년 3월 1일
연구 등록 날짜
최초 제출
2012년 8월 6일
QC 기준을 충족하는 최초 제출
2012년 8월 7일
처음 게시됨 (추정)
2012년 8월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 3월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 3월 12일
마지막으로 확인됨
2014년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ADHD-TEAM-02
- 2486738 (기타 보조금/기금 번호: Shire pharmaceutical development limited)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .