Early Adolescent Skills for Emotions (EASE) for young adolescents in Lebanon

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: 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 Adolescentsâ€?. 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. Previous: 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 n CONDITION: Psychological distress ; Mental and Behavioural Disorders PRIMARY OUTCOME: 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. INCLUSION CRITERIA: 1. Aged between 10 and 14 years; 2. Reside with a caregiver who is able to provide consent; 3. Able and willing to commit to attending the weekly EASE sessions; 4. Screens positive for psychological distress during screening (using 17 item PSC). 5. Children of any nationality and background will be eligible. SECONDARY OUTCOME: ; 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; updated 19/06/2019: It consists of 9 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 questionnaire at T0.; 5. Other:; 5.1 Economic indicators (T0, T1, T2, T3) and barriers to accessing health care (T0) (for cost‐benefit and health‐system analyses), measured using survey questions designed for this study ‐ partly based on the Client Service Receipt Inventory (CSRI); added 19/06/2019: assessed for one child per family only; 5.2 Treatment contamination check, measured using survey questions designed for this study (T1, T2); All outcomes are assessed by a masked team of interviewers not involved in service delivery.;
Epistemonikos ID: c023ef0d295a34437467b0537b8d4927500e29a3
First added on: Aug 24, 2024