the provision of a single-session psychoeducation home visit termed “Psychoeducation for Young Adolescents”. Both the adolescent and caregiver will be invited to the psychoeducation session (of approximately 30 minute duration) in which they will receive brief feedback that the youth indicated psychological distress, as well as scripted psychoeducation about (i) self-care strategies and (ii) seeking services from local health or community services offering MHPSS.
Randomisation will occur following completion of the baseline assessment (T0). Randomisation sequences will be computer generated by an independent researcher who is not involved in any other aspects of the study, using a 1:1.6 allocation to EASE or ETAU group. To support practical implementation and to ensure adequate numbers in the EASE group programmes, separate randomisation sequences will be created for each location where EASE groups are being held, and within this, separate sequences will be used to create strata for age x gender (i.e. boys 10-12; girls 10-12, boys 13-14, girls 13-14). To ensure that equal numbers are allocated to each group, blocking will be used. To ensure that the sequence cannot be guessed at any point in the procedure, random block sizes of 2 and 4 will be used. Group allocations (EASE or ETAU) will be recorded on pieces of paper, which will be folded and placed inside sealed, numbered, opaque envelopes. The numbered envelopes will be opened in sequence with the allocation assigned to the corresponding child on registration lists. This will be documented, and the implementing team will be informed of allocations.
In cases where multiple siblings from one family are eligible for the study, all will be included, but randomized as a single unit to prevent children from the same family being allocated to different intervention arms.
Primary outcome measure
Psychological distress, as assessed by the Paediatric Symptom Checklist 35 (PSC-35) youth-report. This will be assessed at baseline (T0), post-intervention (T1), 3-month follow-up (T2), and 12-month follow-up (T3). The primary outcome timepoint is specified as T2.
Secondary outcome measures
All secondary outcomes will be assessed at T0, T1, T2 and T3. The primary outcome timepoint is specified as T2.
1. Adolescent-reported outcomes
1.1 Symptoms of depression- measured using the 9-item adolescent version of the Patient Health Questionnaire (PHQ-A).
1.2 Symptoms of traumatic stress- measured using the 13-item Children’s Revised Impact of Event Scale (CRIES-13).
1.3 Impairment of Daily Functioning- measured using a questionnaire was developed specifically for this study. It consists of 10 items pertaining to the level of impairment experienced with important daily activities.
1.4 Wellbeing - measured using the 14-item Warwick Edinburgh Mental Wellbeing Scale (WEMWBS).
1.5 Child Use of Coping Strategies- measured via the 7-item Strategy Use Questionnaire (SUQ) developed specifically for the trial
2. Caregiver-reported outcomes
2.1 Caregiver-reported child psychological distress- measured by the PSC35 caregiver-version.
2.2 Caregiver level psychological distress- measured using the Kessler Psychological Distress Scale (K6)
2.3 Parenting- measured using the Alabama Parenting Questionnaire-42 (APQ42)
2.4 Caregiver Use of Coping Strategies- measured via the 8-item Strategy Use Questionnaire (SUQ) developed specifically for the trial
Where a caregiver has multiple children in the study, the APQ42, K6, and caregiver SUQ will only be completed once by the caregiver, while the caregiver-report PSC-35 will be completed separately for each child.
3. Mediator: Mechanisms of treatment, measured using the SUQ child and parent versions.
4. Moderators: The study is not powered for moderation effects, however, we will conduct exploratory analyses of potential moderators, which may include:
4.1 Child exposure to potentially traumatic events, measured at T0 via caregiver report, using a trauma checklist contextually developed for this site
4.2 Various demographic variables measured using a demographic quest