Mental Health DisorderNCT05365503
Dissemination Strategies and Implementation Outcomes of Adolescent Character Strength Interventions.
A study of Mental Health Disorder, run by Shamiri Institute at 3 sites in Kenya.
Trial summary
The present research study will involve investigating the efficacy of large-scale dissemination models of evidence-based character strength interventions in secondary schools in Kenya. Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Disorder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 3 sitesKenya
- Study dates
- 16 May 2022to 31 Oct 2022
- 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 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants must be high school students in one of the selected schools.
- Participants must be between the ages of 12 to 21.
Who cannot join
- There will be no other exclusion criteria.
Trial locations and contacts
3 sites in 1 country.
Kenya3 sites
Shamiri Institute
Kiambu, Central Province
Africa Mental health Research and Training Foundation
Makueni, Eastern Province
Shamiri Institute
Nairobi
About this study
The present research study will involve investigating the efficacy of large-scale dissemination models of evidence-based character strength interventions in secondary schools in Kenya. This intervention, derived from a previously tested intervention named Shamiri, or thrive in Kiswahili, uses positive psychology and accessible life skills to build individual resilience and wellness. This will be a one-arm trial with participants recruited from 20 secondary schools in Nairobi, Kiambu and Makueni counties. The investigators estimate a sample size of 3000 youth, working on an intention to treat basis. All interested participants will be admitted to the program, with no exclusion criteria applied. The investigators will report on the efficacy of character strength interventions on wellbeing and mental health outcomes. Further, the investigators will also assess the scalability and acceptability of the program post intervention. Additionally, the investigators will examine moderator effects on the participants, baseline attributes of the participants, and potentially the effects of candidate mediators on intervention effects.
Read the detailed description
This is a dissemination study whose objective is to explore the effectiveness, acceptability, and scalability of the Shamiri intervention when implemented in a large-scale naturalistic dissemination study in Kenyan secondary schools. Specifically, this study has two broad goals: 1) to test the effectiveness of Shamiri on mental health and psychosocial outcomes when delivered naturalistically on a large scale through either a centralized and de-centralized (train the trainers) administration, and 2) to examine and measure outcomes of these large-scale dissemination models.
For goal 1, participants will receive Shamiri directly through the Shamiri team or through an implementation partner. The investigators will measure mental health and psychosocial outcomes to determine if these outcomes compare to those reported in prior RCTs of Shamiri. The investigators hypothesize that participants receiving Shamiri will experience similar improvements in mental health and psychosocial outcomes as reported in previous RCTs. The investigators don't have a priori hypothesis on whether the mode through which the participants receive the intervention will affect intervention outcomes.
To achieve goal 2, investigators measure the following implementation related outcomes: intervention fidelity, cost, sustainment, acceptability, penetration, and cost-effectiveness. The investigators hypothesize that the Shamiri intervention will achieve high ratings in all intervention outcomes.
- Conditions
- Mental Health Disorder
- Being tested
- Shamiri Intervention
- Keywords
- Depression, Anxiety
- Medical subject headings
- Mental Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shamiri InterventionOther
The first two sessions focus on the concept of growth mindset, the third session focuses on gratitude, and the fourth and final session focuses on values. In session one, participants are guided through a Growth mindset intervention designed to convey the idea that people and their situations can change for the better. In session two, group leaders introduce a discussion and activities about effective strategies for growth. Then, the group leaders introduce a framework for problem solving. In session three, group leaders emphasize the importance of verbalizing and consciously thinking about Gratitude, as well as its benefits for well-being. In the final session, participants are introduced to the concept of values. Participants discuss stories of culturally pertinent role models, with an emphasis on the values these individuals display, and how their values guided their life decisions and led to success and happiness.
| Study group | Role | What they receive |
|---|---|---|
| Shamiri Intervention | Experimental | The Shamiri intervention group will recieve a brief character strength intervention that will be delivered over the span of 4 weeks. There will be four sessions each lasting one hour each. Receives: Other: Shamiri Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety symptoms from baseline to 1-month follow up
Self-reported anxiety symptoms, measured by the Generalized Anxiety Disorder Screener
Measured: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Change in depression symptoms from baseline to 1-month follow up
Self-reported depression symptoms as measured by the Patient Health Questionnaire - 8
Measured: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Change in perceived social support from baseline to 1-month follow up
Self-reported sense of social support, measured by the Multidimensional Scale of Perceived Social Support, with a score range of 0-7, with higher scores indicating greater perception of social support
Measured: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Change in self-reported well-being from baseline to 1-month follow up
Self-reported wellbeing, as measured by the Engagement, Perseverance, Optimism, Connectedness and Happiness Measure of Adolescent Well-Being, with a score range of 1-5, higher scores meaning better well-being
Measured: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Change in academic performance from baseline to 1-month follow up
Academic performance, as measured by the average grade achieved from the school term before the intervention, the school term during which the intervention takes place, and the last term for which academic grades are available.
Measured: Baseline (academic term pre-intervention) and up to 1-month post intervention
Secondary outcomes (5)
Change in self-reported secondary control from baseline to 1-month follow up
Self-reported participant sense of secondary control, or the ability to adjust oneself to hardships in such a way as to control their subjective emotional impact, measured by the 6-item short form of the Secondary Control Scale for Children (score range of 0-18, higher scores indicating greater perceived secondary control)
Measured: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Change in sense of meaning and purpose in life from baseline to 1-month follow up
Self-reported sense of purpose and meaning in life, as measured by the Purpose in Life Scale-12, with a score range of 20-140, higher scores indicating greater perceived meaning in life
Measured: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Change in gratitude from baseline to 1-month follow up
Self-reported gratitude, measured by a 6-item version of the Gratitude Questionnaire, with a score range of 6-48, with higher scores indicating higher gratitude
Measured: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Change in perceived control from baseline to 1-month follow up
Self-reported sense of control over oneself and one's life, measured by the Perceived Control Scale for Children, with a score range of 0-24, with a higher score indicating higher perception of control over one's life
Measured: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Change in mental well-being from baseline to 1-month follow up
Self-reported mental well-being of participants measured by the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS), with a score range of 7-35, higher scores indicating higher positive mental well-being
Measured: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start16 May 2022
- Primary completion30 Jun 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shamiri Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Africa Mental Health Research and Training Foundation, Harvard University, Kenyatta University, WU Vienna University of Economics and Business
- Responsible party
- Sponsor
- Investigators
- Tom L Osborn, Principal investigator, Shamiri Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365503
- Sponsor's protocol ID
- Templeton 2 Phase 2
- Status last verified
- Feb 2023
- First submitted
- 25 Apr 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators intend to share fully de-identified data through publications and upon request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination Strategies and Implementation Outcomes of Adolescent Character Strength Interventions.
- ClinicalTrials.gov ID
- NCT05365503
- Acronym / sponsor ID
- Templeton 2 Phase 2
- Conditions
- Mental Health Disorder
- Keywords
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Shamiri InstituteUniversity, hospital or other
- Collaborators
- Africa Mental Health Research and Training Foundation, Harvard University, Kenyatta University, WU Vienna University of Economics and Business
- Study start
- 16 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 9 May 2022 (actual)
- 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.
The present research study will involve investigating the efficacy of large-scale dissemination models of evidence-based character strength interventions in secondary schools in Kenya. This intervention, derived from a previously tested intervention named Shamiri, or thrive in Kiswahili, uses positive psychology and accessible life skills to build individual resilience and wellness. This will be a one-arm trial with participants recruited from 20 secondary schools in Nairobi, Kiambu and Makueni counties. The investigators estimate a sample size of 3000 youth, working on an intention to treat basis. All interested participants will be admitted to the program, with no exclusion criteria applied. The investigators will report on the efficacy of character strength interventions on wellbeing and mental health outcomes. Further, the investigators will also assess the scalability and acceptability of the program post intervention. Additionally, the investigators will examine moderator effects on the participants, baseline attributes of the participants, and potentially the effects of candidate mediators on intervention effects.
Detailed description
This is a dissemination study whose objective is to explore the effectiveness, acceptability, and scalability of the Shamiri intervention when implemented in a large-scale naturalistic dissemination study in Kenyan secondary schools. Specifically, this study has two broad goals: 1) to test the effectiveness of Shamiri on mental health and psychosocial outcomes when delivered naturalistically on a large scale through either a centralized and de-centralized (train the trainers) administration, and 2) to examine and measure outcomes of these large-scale dissemination models.
For goal 1, participants will receive Shamiri directly through the Shamiri team or through an implementation partner. The investigators will measure mental health and psychosocial outcomes to determine if these outcomes compare to those reported in prior RCTs of Shamiri. The investigators hypothesize that participants receiving Shamiri will experience similar improvements in mental health and psychosocial outcomes as reported in previous RCTs. The investigators don't have a priori hypothesis on whether the mode through which the participants receive the intervention will affect intervention outcomes.
To achieve goal 2, investigators measure the following implementation related outcomes: intervention fidelity, cost, sustainment, acceptability, penetration, and cost-effectiveness. The investigators hypothesize that the Shamiri intervention will achieve high ratings in all intervention outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shamiri Intervention | Experimental | Other: Shamiri InterventionThe Shamiri intervention group will recieve a brief character strength intervention that will be delivered over the span of 4 weeks. There will be four sessions each lasting one hour each. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Participants must be high school students in one of the selected schools.
- Participants must be between the ages of 12 to 21.
Key exclusion criteria (1 listed)
- There will be no other exclusion criteria.
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 |
|---|---|---|
| Shamiri InterventionThe first two sessions focus on the concept of growth mindset, the third session focuses on gratitude, and the fourth and final session focuses on values. In session one, participants are guided through a Growth mindset intervention designed to convey the idea that people and their situations can change for the better. In session two, group leaders introduce a discussion and activities about effective strategies for growth. Then, the group leaders introduce a framework for problem solving. In session three, group leaders emphasize the importance of verbalizing and consciously thinking about Gratitude, as well as its benefits for well-being. In the final session, participants are introduced to the concept of values. Participants discuss stories of culturally pertinent role models, with an emphasis on the values these individuals display, and how their values guided their life decisions and led to success and happiness. | Other | Shamiri Intervention |
Primary outcome
Change in anxiety symptoms from baseline to 1-month follow up
Time frame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Self-reported anxiety symptoms, measured by the Generalized Anxiety Disorder Screener
Change in depression symptoms from baseline to 1-month follow up
Time frame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Self-reported depression symptoms as measured by the Patient Health Questionnaire - 8
Change in perceived social support from baseline to 1-month follow up
Time frame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Self-reported sense of social support, measured by the Multidimensional Scale of Perceived Social Support, with a score range of 0-7, with higher scores indicating greater perception of social support
Change in self-reported well-being from baseline to 1-month follow up
Time frame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Self-reported wellbeing, as measured by the Engagement, Perseverance, Optimism, Connectedness and Happiness Measure of Adolescent Well-Being, with a score range of 1-5, higher scores meaning better well-being
Change in academic performance from baseline to 1-month follow up
Time frame: Baseline (academic term pre-intervention) and up to 1-month post intervention
Academic performance, as measured by the average grade achieved from the school term before the intervention, the school term during which the intervention takes place, and the last term for which academic grades are available.
5 secondary outcomes
Change in self-reported secondary control from baseline to 1-month follow up
Time frame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Change in sense of meaning and purpose in life from baseline to 1-month follow up
Time frame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Change in gratitude from baseline to 1-month follow up
Time frame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Change in perceived control from baseline to 1-month follow up
Time frame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Change in mental well-being from baseline to 1-month follow up
Time frame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
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 2 Feb 2023.
- Individual participant dataSharing planned: Yes. The investigators intend to share fully de-identified data through publications and upon request.
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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.
Tom L Osborn principal investigator
Shamiri Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Mental Health Disorder, run by Shamiri Institute at 3 sites in Kenya.
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 2 inclusion and 1 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 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
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 anxiety symptoms from baseline to 1-month follow up (time frame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up). The study lists 5 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 2 Feb 2023.