Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support
12 maart 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Onbekend
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Verwacht)
100
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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NRW
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Cologne, NRW, Duitsland, 50937
- Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
6 jaar tot 12 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Manfred Doepfner, PhD, University of Cologne
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2012
Primaire voltooiing (Verwacht)
1 december 2014
Studie voltooiing (Verwacht)
1 maart 2015
Studieregistratiedata
Eerst ingediend
6 augustus 2012
Eerst ingediend dat voldeed aan de QC-criteria
7 augustus 2012
Eerst geplaatst (Schatting)
8 augustus 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
13 maart 2014
Laatste update ingediend die voldeed aan QC-criteria
12 maart 2014
Laatst geverifieerd
1 maart 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ADHD-TEAM-02
- 2486738 (Ander subsidie-/financieringsnummer: Shire pharmaceutical development limited)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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