Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support
12 de março de 2014 atualizado por: 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.
Visão geral do estudo
Status
Desconhecido
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
100
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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NRW
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Cologne, NRW, Alemanha, 50937
- Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
6 anos a 12 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Manfred Doepfner, PhD, University of Cologne
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2012
Conclusão Primária (Antecipado)
1 de dezembro de 2014
Conclusão do estudo (Antecipado)
1 de março de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
6 de agosto de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de agosto de 2012
Primeira postagem (Estimativa)
8 de agosto de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
13 de março de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de março de 2014
Última verificação
1 de março de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ADHD-TEAM-02
- 2486738 (Número de outro subsídio/financiamento: Shire pharmaceutical development limited)
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