Condition category
Mental and Behavioural Disorders
Date applied
08/03/2019
Date assigned
11/03/2019
Last edited
11/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Young adolescents living in adversity are at risk of psychological distress and a range of mental disorders. The aim of this study is to test a new intervention with young adolescents in vulnerable communities in Lebanon. The psychological intervention is designed to reduce high psychological distress.

Who can participate?
Young adolescents aged 10-14 who reside in the communities in which we will deliver the intervention, and are experiencing high psychological distress.

What does the study involve?
Young adolescents who are interested in participating and who have parental consent, will take part in a screening interview to determine their eligibility. If eligible, they will be randomly allocated into two groups. Young adolescents in one group are invited to participate in seven group sessions of approximately 90 minutes, and their caregivers will be invited to attend three separate group sessions. Young adolescents in the other group receive enhanced treatment as usual, consisting of a single home-visit session describing psychological distress, its causes, and what one can do to decrease psychological distress; and access to existing services. Various indicators of mental health and wellbeing are measured before, immediately after, 3 months, and 12 months after completion of the intervention.

What are the possible benefits and risks of participating?
Likely benefits include reduced psychological distress and improved wellbeing. Discussion of difficult feelings may lead to temporary increases in psychological distress. In small previous studies this risk has not been observed occurring.

Where is the study run from?
War Child Holland (Lebanon Office)

When is the study starting and how long is it expected to run for?
March 2019 to December 2020

Who is funding the study?
The European Commission under Horizon 2020 – the Framework Programme for Research and Innovation (2014-2020).

Who is the main contact?
Dr Mark Jordans, mark.jordans@warchild.nl

Trial website

https://strengths-project.eu/en/strengths-home/

Contact information

Type

Scientific

Primary contact

Prof Mark Jordans

ORCID ID

http://orcid.org/0000-0001-5925-8039

Contact details

War Child Holland
Helmholtzstraat 61
Amsterdam
1098LE
Netherlands
+31204227777
mark.jordans@warchild.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

EASELebanon

Study information

Scientific title

Early Adolescent Skills for Emotions (EASE) in the treatment of psychological distress for young adolescents in Lebanon: A randomized controlled trial

Acronym

EASE Lebanon

Study hypothesis

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.

Ethics approval

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; cue@usj.edu.lib) ref: ID: USJ – 2017 – 24 bis; and WHO Ethical Review Committee (ERC Secretariat, Avenue Appia 20, Geneva 1211, Switzerland; ercsec@who.int), ref: Protocol ID: ERC.0003000

Study design

Two-arm single-blind individually randomized group treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Psychological distress

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 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.

Intervention type

Behavioural

Phase

Drug names

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 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)
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.

Overall trial start date

01/03/2019

Overall trial end date

01/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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.

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

445

Participant exclusion criteria

1. Unaccompanied minor;
2. Caregiver is not a family member, as they would not be able to provide legal consent;
3. Significant cognitive impairment or severe neurological impairments or developmental difficulties as determined by caregiver-report during screening, where this would impair their ability to participate in a group programme;
4. Imminent risk of suicide;
5. Currently married.

Recruitment start date

01/06/2019

Recruitment end date

30/09/2019

Locations

Countries of recruitment

Lebanon

Trial participating centre

War Child Holland
Hussein Oueini Street
Beirut
14-5693
Netherlands

Sponsor information

Organisation

War Child Holland

Sponsor details

Helmholtzstraat 61G
Amsterdam
1098 LE
Netherlands
0204227777
mark.jordans@warchild.nl

Sponsor type

Charity

Website

www.warchild.nl

Funders

Funder type

Research council

Funder name

European Commission (H2020)

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Mark Jordans, War Child Holland

Intention to publish date

01/02/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/03/2019: Trial’s existence confirmed by IRB