- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03547843
The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder
Peer co-led education describes educators who are expert patients, user representatives or former patients, participating and teaching in educational interventions in cooperation with health care professionals. Peer co-led education is included in the Norwegian national guidelines for treatment of mental disorders, but despite some promising results for the treatment of other conditions, still little is known about the efficacy of peer co-led educational group interventions interventions for adults with attention deficit and hyperactivity disorder (ADHD).
This pilot trial will evaluate patient satisfaction with and preliminary efficacy of a 2-session peer co-led educational group program designed to address specific challenges faced by adults diagnosed with ADHD at an outpatient clinics in mid-Norway.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Trondheim, Norwegen, 7055
- Tiller DPS
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Confirmed ADHD-diagnosis
- speaking a Scandinavian language
Exclusion Criteria:
- Unable to give informed consent
- Psychosis
- Severe learning difficulties
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Educational intervention
Patients randomized to the intervention group will start with a group-based educational program immediately after the randomization.
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The group-based educational program consists of two sessions that run over two consecutive weeks.
Each session consists of a lecture from a recruited expert on the topic of the session and by expert patients with a following discussion of the topic facilitated by the course leader.
Andere Namen:
Diagnostic treatment with medication.
In addition, some patients receive cognitive behavioral therapy (not systematically given to every patient).
If needed, patients are also offered assistance with regard to economy, housing, education, and work as well as contact with family and network.
Andere Namen:
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Aktiver Komparator: Waiting list
Participants randomized to the waiting list control group receive no educational intervention for the duration of the 10 weeks.
During this period participants can receive standard treatment, consisting of diagnostic treatment with medication.
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Diagnostic treatment with medication.
In addition, some patients receive cognitive behavioral therapy (not systematically given to every patient).
If needed, patients are also offered assistance with regard to economy, housing, education, and work as well as contact with family and network.
Andere Namen:
No educational intervention for the duration of the 10 weeks.
During this period participants can receive standard treatment.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in client Satisfaction
Zeitfenster: from baseline to 2-weeks follow-up
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Client satisfaction will be measured with Client Satisfaction Questionnaire, short form (Attkisson & Zwick, 1982).
The scale consists of 8 items scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction).
Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
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from baseline to 2-weeks follow-up
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change in patient activation
Zeitfenster: from baseline to 10-weeks follow-up
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Patient activation will be measured with the Norwegian version of the Patient Activation Measure Mental Health (PAM-MH) (Green et al 2010))
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from baseline to 10-weeks follow-up
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
change in general self-efficacy
Zeitfenster: from baseline to 10 weeks follow-up
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General Self-Efficacy Scale, 6-item scale ranging from 1 ('not at all true') to 4 ('exactly true').
Total scores range from 6 to 24, with higher scores indicating greater self-efficacy.
(Romppel et al 2013)
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from baseline to 10 weeks follow-up
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change in ADHD-related symptoms
Zeitfenster: from baseline to 10 weeks follow-up
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Hopkin's Symptom Checklist (SCL), 9-items scale with high scores on SCL-9 indicating ADHD-related symptom burden (Eich et al 2011)
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from baseline to 10 weeks follow-up
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change in ADHD-related symptoms
Zeitfenster: from baseline to 10 weeks follow-up
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Norwegian version of the WHO Adult ADHD Self-report scale, ASRS Short Form (Kessler et al 2005)
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from baseline to 10 weeks follow-up
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change in Quality of Life
Zeitfenster: from baseline to 10 weeks follow-up
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Adult Attention Deficit/Hyperactivity Disorder Quality of Life Scale, AAQoL short Form (Brod et al 2006)
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from baseline to 10 weeks follow-up
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Use of health services and work participation
Zeitfenster: through study completion, an average of 24 weeks
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Self-reported work participation and received services: 3 questions about both work status and received treatment
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through study completion, an average of 24 weeks
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienleiter: Anne-Lise Løvaas, md phd, St. Olavs Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2017/2405 REK
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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