Phone-Delivered Psychological Intervention (t-CETA) for Mental Health Problems in 8-17 Year-Old Syrian Refugee Children

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Brief Title

Phone-Delivered Psychological Intervention (t-CETA) for Mental Health Problems in 8-17 Year-Old Syrian Refugee Children

Official Title

Development, Piloting and Evaluation of a Phone-Delivered Psychological Intervention (t-CETA) for Syrian Refugee Children in Lebanon: Phase II

Brief Summary

      This study evaluates the effectiveness of t-CETA, a version of Common Elements Treatment
      Approach (CETA) adapted to be delivered over the telephone, in treating common mental health
      problems in 8-17 year old Syrian refugee children living in Lebanon. Children will be
      randomly assigned to receive either t-CETA or treatment as usual provided by Médecins du
      Monde, an NGO providing medical and mental health services to Syrian refugees in Lebanon. If
      families do not agree to randomisation, they will be offered t-CETA and their data will be
      used to evaluate implementation and acceptability of the intervention.

      Symptoms of common mental health problems, including anxiety, depression, PTSD, and
      behavioural problems, and psychological well-being, will be measured before treatment,
      immediately after treatment, and three months after treatment is completed. Groups will be
      compared to determine if t-CETA is at least as effective as standard treatment provided by
      Médecins du Monde.
    

Detailed Description

      Common Elements Treatment Approach (CETA) is a transdiagnostic treatment approach designed to
      treat common mental health problems such as anxiety, depression, post-traumatic stress
      disorder (PTSD), and externalising behaviour problems. It uses a Cognitive Behavioural
      Therapy (CBT) approach and has been used in both adults and children. There are a number of
      different components that can be put together to provide a treatment approach that is
      tailored to each individual. For this study CETA has been adapted to be delivered over the
      telephone (t-CETA).

      The overall study has two specific objectives:

        1. Development of telephone-delivered CETA (t-CETA) by adapting the scientifically
           validated face-to face CETA programme (including manual and detailed training material).
           This was completed during Phase I.

        2. Scientific evaluation of the effectiveness of t-CETA applying a randomized controlled
           clinical trial. This will be completed during Phase II and is described in the remainder
           of this submission.

      Study design:

      The implementation and efficacy of t-CETA will be tested with a randomized controlled
      clinical trial. Up to 120 Syrian refugee children will be randomly allocated to either t-CETA
      or treatment as usual provided by Médecins du Monde in primary healthcare centres in the
      Beqaa valley. Clinical interviews with children and primary caregivers will be conducted
      before the intervention to determine suitability for inclusion. Assessments will be carried
      out before and after the intervention as well as during a 3-month follow-up assessment by
      independent trained enumerators blind to study condition. If families do not agree to
      randomisation, they will be offered t-CETA only and their data will be used to carry out
      additional evaluation of efficacy, implementation and acceptability of the intervention.
      Implementation and acceptance of the intervention will be further assessed with a qualitative
      study based on interviews with a subset of involved Syrian refugee children, their caregivers
      as well as mental health staff.

      Sample:

      Children included in the study will be selected from the large sample of an NICHD funded
      study on the biological pathways of risk and resilience in Syrian refugee children based in
      Lebanon headed by PI Prof. Michael Pluess and co-PI Prof. Elie Karam ("Biological Pathways of
      Risk and Resilience in Syrian Refugee Children" [BIOPATH]; Sponsor: Queen Mary University of
      London [ReDA Ref: 011120]; Ethical approval: Institutional Review Board of the University of
      Balamand, Lebanon [Ref: IRB/O/024-16/1815] and Ministry of Public Health in Lebanon, in
      consultation with the Lebanese National Consultative Committee on Ethics). BIOPATH is a
      longitudinal study and includes 1,600 Syrian refugee families in the Beqaa valley. For each
      of these children there is data on a range of psychological outcomes (PTSD, depression,
      anxiety, externalising behavioural problems). From the 1,600 children, the investigators will
      select up to 120 based on psychological symptoms assessed routinely as part of the BIOPATH
      study. If insufficient numbers of children from the BIOPATH study are recruited, the
      following additional approaches will be used: (i) children from BIOPATH who take part in the
      linked VaST study (which involves completing the MINI KID clinical interview) will be
      approached if they meet inclusion criteria and are interested in accessing mental health
      services; (ii) other children in the families who took part in BIOPATH (e.g., siblings and
      cousins) and for whom families requested mental health services will be approached; (iii)
      referrals will be accepted from other agencies; (iv) information sessions will be conducted
      in the community (e.g., in Informal Tented Settlements) to inform families about the research
      and allow them to request mental health assessment for their child(ren); (v) families in
      contact with participating families will be able to contact the study for information and to
      request mental health assessment for their child (snowballing approach).

      Recruitment:

      Primary caregivers will be contacted over the phone and offered clinical assessment for their
      child at no cost, as part of routine clinical care. Families will be invited to attend an
      appointment at an MdM clinic or be visited at home for this assessment. Families who attend
      the appointment will first undertake a brief interview to establish the presenting problem.
      Following this and providing children do not meet exclusion criteria, they will be offered
      inclusion in the t-CETA study. Those who do not want to participate in research, or who
      clearly meet exclusion criteria, will be offered a standard clinical intake assessment and
      treatment as usual provided by Médecins du Monde. Those who do want to participate in
      research will complete the informed consent process, and a clinical interview
      (Mini-International Neuropsychiatric Interview For Children And Adolescents; MINI KID) and
      severity score (Clinical Global Impression severity score; CGI-s) will then be used to guide
      whether children meet inclusion criteria. Those who do not meet inclusion criteria or whose
      difficulties are not appropriate for CETA will be offered treatment as usual by Médecins du
      Monde or referral to another agency, as appropriate.

      Following recruitment, participants will complete the first in-session assessment (see below
      for assessment details) and be prepared for baseline assessments. A visual aids booklet will
      be provided to assist with responding to questionnaire items and the child and caregiver will
      have the opportunity to answer practice questions using the visual aids.

      The baseline independent assessment will then be conducted via phone (see below for
      assessment details).

      Randomization and blinding:

      Following baseline independent assessment participants will be randomized to either t-CETA or
      treatment as usual (TaU) provided by Médecins du Monde (MdM). Stratified randomization will
      be used by randomizing within each of the following four groups:

        1. Males aged 8-12 years

        2. Males aged 13-17 years

        3. Females aged 8-12 years

        4. Females aged 13-17 years

      Participants and the treatment teams will not be blind to treatment allocation. The team
      carrying out independent assessments and the team carrying out data analysis will be blind to
      treatment allocation.

      If participants do not agree to randomisation, they will be offered t-CETA only; treatment
      and data collection will be identical to that described for children receiving t-CETA as part
      of the RCT.

      Treatment:

      t-CETA: Children will receive telephone delivered therapy 1 or 2 times per week for up to 30
      minutes per session. Treatment will take approximately 8-16 weeks. There will be some
      variation in the number and content of treatment sessions because t-CETA will be tailored to
      each participant depending on the presenting problem(s).

      TaU: Children will receive case manager-led care, involving initial assessment by a case
      manager, with intervention then provided by a case manager, and/or referral to a
      psychotherapist or psychiatrist as necessary. Médecins du Monde's approach is based on a
      joint collaboration between mental health trained case managers (who undergo extensive
      training by experts in the field on topics including Psychological First Aid, Child
      Protection, Gender Based Violence, etc.) and psychotherapists from different schools
      (providing Eye Movement Desensitization and Reprocessing [EMDR] for trauma, Interpersonal
      Therapy [IPT] for depression, Cognitive Behavioural Therapy [CBT], motivational counselling,
      familial or systemic therapy, and integrative approaches). Thus the number and content of
      sessions, and the person delivering treatment (case manager, psychotherapist, psychiatrist)
      will vary.

      Supervision:

      Both t-CETA and TaU teams will be closely supervised by experienced clinical psychologists.
      Supervision will occur during weekly sessions, with more frequent supervision for challenging
      cases and to manage safety issues.

      Independent Assessments:

      Trained assessors will be independent of the treatment team and blind to treatment condition.
      They will conduct assessments over the phone (or face-to-face if phone assessment is not
      possible). This will take approximately 30-45 minutes per child and 30-45 minutes per
      caregiver. The assessment includes standardized questionnaires about the child's symptoms and
      adaptive functioning. Participants will have the option to use the visual aids booklet
      provided to help them respond to questions. Data will be entered into the online platform
      Qualtrics, uploaded to a secure server. Participants will only be identified using an ID on
      Qualtrics; identifying details will not be entered. The assessment process will be supervised
      by a qualified clinical psychologist (Local PI, Dr Tania Bosqui).

      Independent assessments will be conducted at baseline (pre-treatment), immediately following
      treatment, and at three months follow-up.

      In-session assessment:

      The case managers providing treatment will conduct these assessments, hence they will not be
      blind to treatment condition.

      Client Monitoring Form (CMF): The CMF is a key part of t-CETA treatment: it is intended to
      guide selection of t-CETA components and monitor progress. It is a questionnaire measure and
      is developed to be specific to each population in which CETA or t-CETA is used. In this study
      it will also be used with children receiving TaU. It will be administered at baseline and
      then weekly at the beginning of treatment sessions.

      PSYCHLOPS: This questionnaire will be used during the first treatment session, during the
      session that is the approximate mid-point, and the final session.
    


Study Type

Interventional


Primary Outcome

Emotional and behavioural problem composite score

Secondary Outcome

 Child PTSD Symptom Scale (CPSS)

Condition

Depression

Intervention

t-CETA

Study Arms / Comparison Groups

 t-CETA
Description:  Telephone-delivered Common Elements Treatment Approach (t-CETA). t-CETA sessions of up to 30 minutes will be delivered 1-2 times per week for approximately 8-12 weeks. The number and content of sessions will be tailored to each child, thus there will be some variation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

21

Start Date

May 1, 2019

Completion Date

January 31, 2020

Primary Completion Date

January 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Age 8-17 years, male or female

          2. Live with a parent or other legal guardian

          3. Child and/or parent identifies that the child has mental health difficulties and
             requests services

          4. At high risk of having a mental disorder as indexed by falling in the top 40% of the
             distribution in any one of the following child-report questionnaires: (i) Screen for
             Child Anxiety Related Emotional Disorders (SCARED), (ii) Center for Epidemiological
             Studies Depression Scale for Children (CES-DC), (iii) Child PTSD Symptom Scale (CPSS);
             AND falling in the top 40% of the distribution in the following parent report
             questionnaire: Strengths and Difficulties Questionnaire (SDQ) total difficulties
             [Criterion 4 is only applicable to children for whom these data are available from
             participation in the BIOPATH study; Criterion 5 takes precedence over Criterion 4
             where both are available]

          5. Confirmation of significant level of symptoms and functional impairment on clinical
             interview (MINI KID) as indicated by (i) meeting full or probable diagnostic criteria
             for ANY of the following: any category of mood disorder, any category of anxiety
             disorder, PTSD, conduct disorder, or oppositional defiant disorder; AND (ii) Clinical
             Global Impression severity (CGI-s) score of >3

          6. Parent/legal guardian gives informed consent and child gives assent to take part

        Exclusion Criteria:

          1. Problem for which t-CETA would not be appropriate, including psychiatric disorders for
             which CETA treatment is not recommended (e.g., bipolar disorder, psychosis), severe
             distress (e.g., acute suicidal ideation), or problems that would preclude delivery
             over the telephone (e.g., selective mutism)

          2. Parent or legal guardian is not able to provide consent

          3. Child protection issues (e.g., acute maltreatment) that are judged by clinician to
             make trial inclusion inappropriate

          4. Any inclusion criteria not met
      

Gender

All

Ages

8 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Michael Pluess, PhD, , 

Location Countries

Lebanon

Location Countries

Lebanon

Administrative Informations


NCT ID

NCT03887312

Organization ID

ReDA_012540

Secondary IDs

28371

Responsible Party

Principal Investigator

Study Sponsor

Queen Mary University of London

Collaborators

 Médecins du Monde

Study Sponsor

Michael Pluess, PhD, Principal Investigator, Queen Mary University of London


Verification Date

February 2020