Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support
12 de marzo de 2014 actualizado 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Anticipado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
NRW
-
Cologne, NRW, Alemania, 50937
- Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
6 años a 12 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: 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.
|
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Manfred Doepfner, PhD, University of Cologne
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2012
Finalización primaria (Anticipado)
1 de diciembre de 2014
Finalización del estudio (Anticipado)
1 de marzo de 2015
Fechas de registro del estudio
Enviado por primera vez
6 de agosto de 2012
Primero enviado que cumplió con los criterios de control de calidad
7 de agosto de 2012
Publicado por primera vez (Estimar)
8 de agosto de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
13 de marzo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
12 de marzo de 2014
Última verificación
1 de marzo de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ADHD-TEAM-02
- 2486738 (Otro número de subvención/financiamiento: Shire pharmaceutical development limited)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .