- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Trondheim, Norvegia, 7055
- Tiller DPS
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Confirmed ADHD-diagnosis
- speaking a Scandinavian language
Exclusion Criteria:
- Unable to give informed consent
- Psychosis
- Severe learning difficulties
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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.
Altri nomi:
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Comparatore attivo: 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.
Altri nomi:
No educational intervention for the duration of the 10 weeks.
During this period participants can receive standard treatment.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in client Satisfaction
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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change in general self-efficacy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Use of health services and work participation
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
Investigatori
- Direttore dello studio: Anne-Lise Løvaas, md phd, St. Olavs Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2017/2405 REK
Piano per i dati dei singoli partecipanti (IPD)
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