Feasibility trial of a psychological intervention with young adolescents in Lebanon

The requested reference [086539c0d36838a49e90451fd27fc4378ecdc9d6] no longer exists in our database. It has been replaced by the current reference: [c5e36d815f4aa74e33ed326c3f1c7a9c6153e899]

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
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 X90‐minute group sessions for adolescents and 3 X120‐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 consists 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 occurs following completion of the T0 assessment. Randomisation sequences are computer generated by an independent staff member not involved in study implementation, using random block sizes of 2 and 4. To support practical implementation and to ensure adequate numbers in the EASE group interventions, separate randomisation sequences are created for males, females, and sibling pairs. Group allocations (EASE or ETAU) are recorded on pi CONDITION: Psychological distress ; Mental and Behavioural Disorders PRIMARY OUTCOME: Psychological distress measured using the Paediatric Symptom Checklist 35 (PSC‐35) youth report at baseline (T0), post‐intervention (T1), and 3‐month follow‐up (T2) INCLUSION CRITERIA: 1. Aged between 10 and 14 years old 2. Reside with a caregiver who is able to provide consent 3. Screens positive for psychological distress during screening (using Child Psychosocial Distress Screener) 4. Children of any nationality and background will be eligible SECONDARY OUTCOME: ; All secondary outcomes are assessed at T0, T1, and 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 that was developed specifically for this study. The questionnaire consisted of 10 items pertaining to the level of impairment experienced with important daily activities; updated 19/06/2019: to consist 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); ; 2. Caregiver‐reported outcomes:; 2.1 Caregiver‐reported child psychological distress measured using 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); ; Where a caregiver has multiple children in the study, the APQ42 and K6 will only be completed once by the caregiver, while the caregiver‐report PSC‐35 will be completed separately for each child.; ; Moderators: The study is not powered for moderation effects, however, we will conduct an exploratory analysis of the potential moderating effect of child exposure to potentially traumatic events, measured at T0 via caregiver report, using a trauma checklist contextually developed for this site; ; 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: 843c52e95b2225cb77c26d9de0c6fc677f7443ab
First added on: Aug 26, 2024