Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support
12 marzo 2014 aggiornato da: 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.
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Anticipato)
100
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
NRW
-
Cologne, NRW, Germania, 50937
- Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 6 anni a 12 anni (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: 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.
|
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Manfred Doepfner, PhD, University of Cologne
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 maggio 2012
Completamento primario (Anticipato)
1 dicembre 2014
Completamento dello studio (Anticipato)
1 marzo 2015
Date di iscrizione allo studio
Primo inviato
6 agosto 2012
Primo inviato che soddisfa i criteri di controllo qualità
7 agosto 2012
Primo Inserito (Stima)
8 agosto 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
13 marzo 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 marzo 2014
Ultimo verificato
1 marzo 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ADHD-TEAM-02
- 2486738 (Altro numero di sovvenzione/finanziamento: Shire pharmaceutical development limited)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Enhancement with psychosocial intervention
-
Fundació Sant Joan de DéuCompletatoDisturbo dello spettro autisticoSpagna