Psychiatric HospitalizationNCT02674932
Character Strengths Intervention Among Psychiatrically Hospitalized Youth
A study testing Identifying and Using Signature Strengths, Identifying and Writing Down Coping Skills and Treatment as Usual in people with Psychiatric Hospitalization and Mental Disorders, run by University of Michigan.
Trial summary
Research has shown that identifying and using one's character strengths in new ways decreases depressive symptoms and increases happiness in adults in the general population. Recently, we found that a similar intervention increases the self-esteem and self-efficacy of children and adolescents being treated in an… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Psychiatric Hospitalization, Mental Disorders, Child/Adolescent Problems
- What is being tested?
- Identifying and Using Signature Strengths, Identifying and Writing Down Coping Skills and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient on Child and Adolescent Psychiatric Unit
Who cannot join
- Cognitive disability or severe psychosis preventing understanding of survey measures
- Prior use of VIA-Youth Survey
- Absence of legal guardian to consent
About this study
Official title: Assessment of a Character Strengths Intervention in Improving Treatment Outcomes Among Psychiatrically Hospitalized Youth
Research has shown that identifying and using one's character strengths in new ways decreases depressive symptoms and increases happiness in adults in the general population. Recently, we found that a similar intervention increases the self-esteem and self-efficacy of children and adolescents being treated in an inpatient psychiatric unit. The purpose of this study is to better understand the effects that discovering one's character strengths and incorporating them into coping skills will have on treatment outcomes in patients admitted to a child and adolescent inpatient psychiatric unit.
Read the detailed description
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.
- Being tested
- Identifying and Using Signature Strengths, Identifying and Writing Down Coping Skills, Treatment as Usual
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identifying and Using Signature StrengthsBehavioural
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.
Identifying and Writing Down Coping SkillsBehavioural
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.
Treatment as UsualBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Signature Strengths | Experimental | 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. Receives: Behavioral: Identifying and Using Signature Strengths |
| Coping Skills + Memory Aid | Active comparator | 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. Receives: Behavioral: Identifying and Writing Down Coping Skills |
| Coping Skills (Treatment as Usual) | Other | 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). Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression symptoms over time compared to baseline
Depression will be measured using Patient Health Questionnaire (PHQ) for adolescents, and percent change in depression score will be compared across the 3 arms.
Measured: baseline, 3 days, 1 month, 3 months
Change in anxiety symptoms over time compared to baseline
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.
Measured: baseline, 3 days, 1 month, 3 months
Secondary outcomes (4)
Change in self-esteem over time compared to baseline
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.
Measured: baseline, 3 days, 1 month, 3 months
Change in self-efficacy over time compared to baseline
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.
Measured: baseline, 3 days, 1 month, 3 months
Change in resiliency over time compared to baseline
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.
Measured: baseline, 3 days, 1 month, 3 months
Change in life-satisfaction over time compared to baseline
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.
Measured: baseline, 3 days, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric HospitalizationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paresh Patel, University of Michigan
- Investigators
- Paresh D Patel, MD, PhD, Principal investigator, Department of Psychiatry, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674932
- Sponsor's protocol ID
- HUM00107976
- Status last verified
- Aug 2019
- First submitted
- 29 Jan 2016
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Character Strengths Intervention in Improving Treatment Outcomes Among Psychiatrically Hospitalized Youth
- ClinicalTrials.gov ID
- NCT02674932
- Acronym / sponsor ID
- HUM00107976
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research has shown that identifying and using one's character strengths in new ways decreases depressive symptoms and increases happiness in adults in the general population. Recently, we found that a similar intervention increases the self-esteem and self-efficacy of children and adolescents being treated in an inpatient psychiatric unit. The purpose of this study is to better understand the effects that discovering one's character strengths and incorporating them into coping skills will have on treatment outcomes in patients admitted to a child and adolescent inpatient psychiatric unit.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Signature Strengths | Experimental | Behavioral: Identifying and Using Signature StrengthsPatients 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. |
| Coping Skills + Memory Aid | Active comparator | Behavioral: Identifying and Writing Down Coping SkillsPatients 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. |
| Coping Skills (Treatment as Usual) | Other | Behavioral: Treatment as UsualPatients 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). |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patient on Child and Adolescent Psychiatric Unit
Key exclusion criteria (3 listed)
- Cognitive disability or severe psychosis preventing understanding of survey measures
- Prior use of VIA-Youth Survey
- Absence of legal guardian to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identifying and Using Signature StrengthsThe 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. | Behavioural | Signature Strengths |
| Identifying and Writing Down Coping SkillsThe 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. | Behavioural | Coping Skills + Memory Aid |
| Treatment as UsualThe 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). | Behavioural | Coping Skills (Treatment as Usual) |
Primary outcome
Change in depression symptoms over time compared to baseline
Time frame: 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.
Change in anxiety symptoms over time compared to baseline
Time frame: 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.
4 secondary outcomes
Change in self-esteem over time compared to baseline
Time frame: baseline, 3 days, 1 month, 3 months
Change in self-efficacy over time compared to baseline
Time frame: baseline, 3 days, 1 month, 3 months
Change in resiliency over time compared to baseline
Time frame: baseline, 3 days, 1 month, 3 months
Change in life-satisfaction over time compared to baseline
Time frame: baseline, 3 days, 1 month, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paresh D Patel, MD, PhD principal investigator
Department of Psychiatry, University of Michigan
Questions about this trial
What is this clinical trial studying?
A study testing Identifying and Using Signature Strengths, Identifying and Writing Down Coping Skills and Treatment as Usual in people with Psychiatric Hospitalization and Mental Disorders, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression symptoms over time compared to baseline (time frame: baseline, 3 days, 1 month, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.