- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02674932
Character Strengths Intervention Among Psychiatrically Hospitalized Youth
Assessment of a Character Strengths Intervention in Improving Treatment Outcomes Among Psychiatrically Hospitalized Youth
Panoramica dello studio
Stato
Descrizione dettagliata
The primary aim of this study is to investigate whether a character strengths-based intervention results in significant improvements in measures of depression, anxiety, resiliency, optimism, self-perception, and life-satisfaction of psychiatrically hospitalized youth up to three months following admission. Secondary aims are to: (1) examine participants' strengths profile to identify potential correlates between character strengths, psychiatric diagnoses and intervention effectiveness; and (2) determine whether patients who continue to incorporate their strengths into coping skills at follow-up assessments exhibit greater improvement over-time.
Participants will be 210 adolescents aged 12 to 17 years admitted to the Child and Adolescent Psychiatric Inpatient Program and will be randomized into one of the three groups. All participants will complete the Values in Action Inventory of Strengths for Youth (VIA-Youth) Survey on their second hospital day and subsequently receive the signature strengths intervention (experimental group), coping skills with memory aids comparison exercise (positive control group), or coping skills without memory aids (treatment-as-usual control group). Outcome measures will be completed by all participants at baseline (day 1 on unit), post-treatment (day 4 on unit), and 1- and 3-months following admission. The proposed research represents a change in paradigm, as we aim to specifically examine the therapeutic benefit of the positive psychology element of our intervention conducted in the pilot study among youth with severe mental illness.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patient on Child and Adolescent Psychiatric Unit
Exclusion Criteria:
- Cognitive disability or severe psychosis preventing understanding of survey measures
- Prior use of VIA-Youth Survey
- Absence of legal guardian to consent
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Signature Strengths
Patients will complete the Values in Action Youth Survey (VIA-Youth) and will receive a list of his/her top character strengths ("signature strengths").
The patient will then participate in the Identifying and Using Signature Strengths Intervention.
|
The purpose of the intervention is to identify and focus on one's morally valued strengths and utilize them (i.e.
incorporate them into coping skills) to overcome challenges.
The study team member and patient will discuss each top strength and ways to use them as coping skills.
The patient will identify 2-4 coping mechanisms per strength, and will write his/her strengths and self-identified coping skills on index cards.
|
|
Comparatore attivo: Coping Skills + Memory Aid
Patients will complete the VIA-Youth but will not receive any results.
The patient will then participate in the Identifying and Writing Down Coping Skills Intervention.
|
The study team member and patient will discuss the importance of having coping skills to deal with stressful and difficult situations.
The patient will then identify at least six coping skills and write them down on index cards.
|
|
Altro: Coping Skills (Treatment as Usual)
Patients will complete the VIA-Youth but will not receive any results.
After completing the VIA-Youth, the study team member and patient will have a treatment-as-usual discussion about coping skills.
(This is equivalent to treatment as usual that is already provided on the psychiatric unit-doctors and nurses on the unit already have this a discussion about coping skills with patients).
|
The study team member and patient will discuss the importance of having coping skills to deal with stressful and difficult situations.
The patient will then identify coping skills that could be helpful (but will not write them down).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in depression symptoms over time compared to baseline
Lasso di tempo: baseline, 3 days, 1 month, 3 months
|
Depression will be measured using Patient Health Questionnaire (PHQ) for adolescents, and percent change in depression score will be compared across the 3 arms.
|
baseline, 3 days, 1 month, 3 months
|
|
Change in anxiety symptoms over time compared to baseline
Lasso di tempo: baseline, 3 days, 1 month, 3 months
|
Anxiety will be measured using the 5-item Screen for Child Anxiety Related Emotional Disorders (SCARED), and percent change in anxiety score will be compared across the 3 arms.
|
baseline, 3 days, 1 month, 3 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in self-esteem over time compared to baseline
Lasso di tempo: baseline, 3 days, 1 month, 3 months
|
Self-esteem will be measured using the Rosenberg Self-Esteem Scale (SES), and percent change in self-esteem score will be compared across the 3 arms.
|
baseline, 3 days, 1 month, 3 months
|
|
Change in self-efficacy over time compared to baseline
Lasso di tempo: baseline, 3 days, 1 month, 3 months
|
Self-efficacy will be measured using the General Self-Efficacy Scale (GSE), and percent change in self-efficacy score will be compared across the 3 arms.
|
baseline, 3 days, 1 month, 3 months
|
|
Change in resiliency over time compared to baseline
Lasso di tempo: baseline, 3 days, 1 month, 3 months
|
Resiliency will be measured using the 10-item Connor Davidson Resiliency Scale (CD-RISC-10), and percent change in resiliency score will be compared across the 3 arms.
|
baseline, 3 days, 1 month, 3 months
|
|
Change in life-satisfaction over time compared to baseline
Lasso di tempo: baseline, 3 days, 1 month, 3 months
|
Life satisfaction will be measured using the Brief Multidimensional Students' Life Satisfaction Scale - PTPB version (BMSLSS-PTPB), and percent change in life satisfaction score will be compared across the 3 arms.
|
baseline, 3 days, 1 month, 3 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Paresh D Patel, MD, PhD, Department of Psychiatry, University of Michigan
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 (Stima)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HUM00107976
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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 .