Testing the effects of the Shamiri Intervention and its components on anxiety, depression, wellbeing, and academic functioning in Kenyan adolescents: study protocol for a five-arm randomized controlled trial

Abstract

Background Treatments for youth mental disorders are a public health priority, especially in sub-Saharan Africa (SSA), where treatment options remain limited due to high cost, elevated stigma, and lack of trained mental health professionals. Brief, accessible, and non-stigmatizing community-based interventions delivered by lay providers may help address treatment needs in SSA. One such intervention, the Shamiri Intervention, consisting of three elements (growth mindset, gratitude, and value affirmation) has been tested in randomized controlled trials with school-going Kenyan adolescents. This three-element Shamiri Intervention has been shown to significantly reduce depression and anxiety symptoms and improve social support and academic performance relative to a control group. In this trial, we aim to investigate the effects of each element of the Shamiri Intervention. Methods In this five-arm randomized controlled trial, we will test each of the intervention components (growth mindset, gratitude, and value affirmation) against the full Shamiri Intervention and against a study skills control intervention. Students (Nplanned = 1288) at participating secondary schools who are interested in participating in this universal intervention will be randomized in equal numbers into the five groups. The students will meet in groups of 8–15 students led by local high school graduate lay providers. These lay providers will receive a brief training, plus expert supervision once a week throughout the intervention delivery. Multi-level models will be used to compare trajectories over time of the primary outcomes (depressive symptoms, anxiety symptoms, academic performance, and wellness) and secondary outcomes in each intervention group to the control group. Multi-level models will also be used to compare trajectories over time of the primary outcomes (depressive symptoms, anxiety symptoms, academic performance, and wellness) and secondary outcomes of participants in the single-element interventions compared to the full Shamiri Intervention. Finally, effect sizes (calculated as mean gain scores) will be used to compare all groups on all measures. Discussion This trial will shed light on the mechanisms and outcomes targeted by each individual intervention, helping prioritize which mental health interventions are most important to disseminate. Trial registration PACTR Trial ID: PACTR202104716135752. Approved on 4/19/2021.

Long-term health outcomes of adolescent character strength interventions: 3- to 4-year outcomes of three randomized controlled trials of the Shamiri program

“…All participants who have taken part in three previous RCTs [ 15 , 20 , 21 ] of the in-person, group-based, 4-week Shamiri intervention, and had elevated symptoms of depression or anxiety at baseline of the previous RCTs (defined as scores of 10 or over on the Generalized Anxiety Disorder-7 (GAD) and 15 or over on the Patient Health Questionnaire-8 (PHQ-8)) are eligible for enrolment in this long-term follow-up study. Participant consent or assent, and in the case of minors, guardian consent, will also be required for participation.…”

“…For primary analyses, the Shamiri intervention will be compared to a Study Skills active control condition of equal duration and highly similar format. As detailed further in a protocol for one of the three RCTs [ 21 ] from which participants will be drawn for this study, the Study Skills active control condition was selected as a comparator for several reasons. First, active control conditions typically provide a more robust comparison than no-treatment or waitlist control conditions [ 22 ].…”

“…Participants will not participate in the intervention or control condition again as part of this study but instead will complete follow-up measures to assess the long-term effects of these interventions. These interventions are further detailed in the intervention descriptions of our previous three RCTs [ 15 , 20 , 21 ]. Each condition consisted of an equal dose of total intervention time: four 1-h weekly sessions that focused on teaching and reinforcing the knowledge and application of the active ingredient of the condition.…”

“…Each single-element intervention (i.e., growth only, gratitude only, or values only intervention) included the elements related to this one element in the combined Shamiri condition, along with additional related activities to teach and practice the same principles. Sample intervention protocols can be found in the supplementary materials for a previous article on Shamiri [ 21 ]. The general format for each intervention was as follows: In session 1, participants completed baseline measures, were introduced to the guidelines for the group and completed group activities to introduce themselves.…”

“…This study also indicated that Shamiri is feasible and acceptable to Kenyan youths. A third ongoing trial is intended to investigate the effects of each of the three components of the Shamiri intervention against the full Shamiri protocol and an active study skills control group [ 21 ].…”