- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02674932
Character Strengths Intervention Among Psychiatrically Hospitalized Youth
Assessment of a Character Strengths Intervention in Improving Treatment Outcomes Among Psychiatrically Hospitalized Youth
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Aktiver Komparator: 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.
|
|
Sonstiges: 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).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in depression symptoms over time compared to baseline
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in self-esteem over time compared to baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Paresh D Patel, MD, PhD, Department of Psychiatry, University of Michigan
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HUM00107976
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