Background <p>Adolescence is a crucial developmental period characterized by increased challenges in emotion regulation, a key mechanism linked to mental health. In Kenya, one in every two adolescents and youth faces a mental health challenge, highlighting a need for early interventions targeting emotion regulation. This study will evaluate the efficacy and acceptability of MAISHA, a blended indicated mental health intervention co-designed with young people to strengthen emotion regulation among those experiencing related difficulties.</p> Methods <p>In a parallel group, cluster-randomized 2 × 2 factorial controlled trial, 666 young people aged 13–25 will be randomly allocated to one of four 4-week study arms at a ratio of 1:1:1:1. (1) digital app blended with a face-to-face element; (2) digital app only; (3) face-to-face element only; or (4) care as usual (CAU). The digital app will build on an ecological momentary intervention. The face-to-face element will consist of four group sessions on growth mindset, values, and gratitude. The primary outcome is emotion regulation difficulties, assessed post-intervention using the short form of the Difficulties in Emotion Regulation Scale (DERS-SF), and comparing the blended intervention (digital and face-to-face) to CAU. Secondary measures include emotional reactivity, emotional distress, positive and negative affect, acceptability, desirability, safety, and usability. The trial will include an embedded micro-randomized trial and a process evaluation.</p> Discussion <p>This trial advances adolescent global mental health by strengthening evidence on youth-focused, mechanism-informed, blended interventions while also highlighting participatory approaches in LMICs.</p> Trial registration <p>The trial was registered in the Pan African Clinical Trials Registry on July 17th, 2025, as PACTR202507903096871 (<a href="https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=34896">https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=34896</a>).</p>

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Efficacy and acceptability of a blended intervention for emotion regulation (MAISHA) among young people in Kenya: study protocol for a cluster RCT

  • Esther Rugendo,
  • Glorialoveness S. Lyimo,
  • Rahim Daya,
  • Moreen Githinji,
  • Kevin Kashamba,
  • Faith Njoki,
  • Innocent Yusufu,
  • Tom Osborn,
  • Rachel P. Chase,
  • Mary Sando,
  • Azan Nyundo,
  • Till Bärnighausen,
  • Ulrich Reininghaus,
  • Shannon A. McMahon,
  • Annika Stefanie Reinhold

摘要

Background

Adolescence is a crucial developmental period characterized by increased challenges in emotion regulation, a key mechanism linked to mental health. In Kenya, one in every two adolescents and youth faces a mental health challenge, highlighting a need for early interventions targeting emotion regulation. This study will evaluate the efficacy and acceptability of MAISHA, a blended indicated mental health intervention co-designed with young people to strengthen emotion regulation among those experiencing related difficulties.

Methods

In a parallel group, cluster-randomized 2 × 2 factorial controlled trial, 666 young people aged 13–25 will be randomly allocated to one of four 4-week study arms at a ratio of 1:1:1:1. (1) digital app blended with a face-to-face element; (2) digital app only; (3) face-to-face element only; or (4) care as usual (CAU). The digital app will build on an ecological momentary intervention. The face-to-face element will consist of four group sessions on growth mindset, values, and gratitude. The primary outcome is emotion regulation difficulties, assessed post-intervention using the short form of the Difficulties in Emotion Regulation Scale (DERS-SF), and comparing the blended intervention (digital and face-to-face) to CAU. Secondary measures include emotional reactivity, emotional distress, positive and negative affect, acceptability, desirability, safety, and usability. The trial will include an embedded micro-randomized trial and a process evaluation.

Discussion

This trial advances adolescent global mental health by strengthening evidence on youth-focused, mechanism-informed, blended interventions while also highlighting participatory approaches in LMICs.

Trial registration

The trial was registered in the Pan African Clinical Trials Registry on July 17th, 2025, as PACTR202507903096871 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=34896).