t Skills for Emotions (EASE) in the treatment of psychological distress for young adolescents in Lebanon: A randomized controlled trial
We hypothesise that children and caregivers assigned to receive the EASE intervention, will show significantly greater improvements on all outcome measures, compared to enhanced treatment as usual) at post-intervention (T1) and 3-month follow-up (T2), and that these gains will be maintained at 12 month follow-up (T3). We hypothesise that treatment effects will be mediated by increased caregiver and child use of coping strategies.
Approved 20/03/2018, St Joseph’s University in Lebanon (Centre universitaire d'ethique, Campus des sciences medicales, rue de Dumas, BP 11-5076, Riad el Solh, Beyrouth, Lebanon; 961-1-421229; email@example.com) ref: ID: USJ – 2017 – 24 bis; and WHO Ethical Review Committee (ERC Secretariat, Avenue Appia 20, Geneva 1211, Switzerland; firstname.lastname@example.org), ref: Protocol ID: ERC.0003000
Two-arm single-blind individually randomized group treatment trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
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Adolescents in participating communities in Lebanon are randomised to the following two conditions.
1. The Early Adolescent Skills for Emotions (EASE) program. This is a group psychological intervention based on empirically‐supported strategies for emotional disorders in children and young people. It consists of 7 x 90-minute group sessions for adolescents and 3 x 120-minute group sessions for their caregivers. Adolescent sessions involve the following strategies: psychoeducation, problem solving, stress management (slow breathing), behavioural activation, and relapse prevention. The caregiver sessions involve: psychoeducation, active listening, quality time, praise, caregiver self-care and relapse prevention.
2. The control condition will consist of enhanced treatment as usual (ETAU), which will involve 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