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

NCT03887312 | Completed DMC

• 2 other identifiers: ReDA_01254028371
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; PTSD; Conduct Disorder; Oppositional Defiant Disorder

Keywords

Phone-delivered therapy; Cognitive behavioral therapy (CBT); Telephone-delivered therapy; Children; Adolescents; Syrian refugees

Outcome Measures

Primary Outcomes (9)

• Emotional and behavioural problem composite score

  Measures common emotional and behavioural problems in children. Scores from the following questionnaire measures will be aggregated: Child PTSD Symptom Scale (CPSS; child self-report), Center for Epidemiological Studies Depression Scale for Children (CES-DC; child self-report), Screen for Child Anxiety Related Emotional Disorders (SCARED; child self-report), the Strengths and Difficulties Questionnaire (SDQ; parent report) externalising score, and conduct disorder / oppositional defiant disorder items (caregiver report). Arabic versions of all questionnaires are used. Scores on these questionnaires have been divided into deciles based on data from the population from which the study sample is drawn and each decile is converted into a score ranging from 0 (lowest decile) to 9 (highest decile). These decile scores are then summed for the four questionnaire measures, giving a total score ranging from 0 to 36. Higher scores indicate greater problems.

  Baseline (pre-treatment)

• Emotional and behavioural problem composite score

  Measures common emotional and behavioural problems in children. Scores from the following questionnaire measures will be aggregated: Child PTSD Symptom Scale (CPSS; child self-report), Center for Epidemiological Studies Depression Scale for Children (CES-DC; child self-report), Screen for Child Anxiety Related Emotional Disorders (SCARED; child self-report), the Strengths and Difficulties Questionnaire (SDQ; parent report) externalising score, and conduct disorder / oppositional defiant disorder items (caregiver report). Arabic versions of all questionnaires are used. Scores on these questionnaires have been divided into deciles based on data from the population from which the study sample is drawn and each decile is converted into a score ranging from 0 (lowest decile) to 9 (highest decile). These decile scores are then summed for the four questionnaire measures, giving a total score ranging from 0 to 36. Higher scores indicate greater problems.

  Approximately 12 weeks (immediately after treatment has been completed)

• Emotional and behavioural problem composite score

  Measures common emotional and behavioural problems in children. Scores from the following questionnaire measures will be aggregated: Child PTSD Symptom Scale (CPSS; child self-report), Center for Epidemiological Studies Depression Scale for Children (CES-DC; child self-report), Screen for Child Anxiety Related Emotional Disorders (SCARED; child self-report), the Strengths and Difficulties Questionnaire (SDQ; parent report) externalising score, and conduct disorder / oppositional defiant disorder items (caregiver report). Arabic versions of all questionnaires are used. Scores on these questionnaires have been divided into deciles based on data from the population from which the study sample is drawn and each decile is converted into a score ranging from 0 (lowest decile) to 9 (highest decile). These decile scores are then summed for the four questionnaire measures, giving a total score ranging from 0 to 36. Higher scores indicate greater problems.

  Approximately 24 weeks (3 months following completion of treatment)

• World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): child report

  WHODAS-child orginally adapted for Rwanda and then translated into Arabic for use with Syrian children (child self-report). Measures three domains of functional impairment: getting along with people, life activities (ability to carry out responsibilities at home and school), and participation in society (ability to engage in community, civil and recreational activities). Subscales are averaged to produce a Global Disability score. Scores are expressed as a percentage so range from 0-100, with higher scores indicating greater impairment.

  Baseline (pre-treatment)

• World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): child report

  WHODAS-child orginally adapted for Rwanda and then translated into Arabic for use with Syrian children (child self-report). Measures three domains of functional impairment: getting along with people, life activities (ability to carry out responsibilities at home and school), and participation in society (ability to engage in community, civil and recreational activities). Subscales are averaged to produce a Global Disability score. Scores are expressed as a percentage so range from 0-100, with higher scores indicating greater impairment.

  Approximately 12 weeks (immediately after treatment has been completed)

• World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): child report

  WHODAS-child orginally adapted for Rwanda and then translated into Arabic for use with Syrian children (child self-report). Measures three domains of functional impairment: getting along with people, life activities (ability to carry out responsibilities at home and school), and participation in society (ability to engage in community, civil and recreational activities). Subscales are averaged to produce a Global Disability score. Scores are expressed as a percentage so range from 0-100, with higher scores indicating greater impairment.

  Approximately 24 weeks (3 months following completion of treatment)

• World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): caregiver report

  WHODAS-child orginally adapted for Rwanda and then translated into Arabic for use with Syrian children (caregiver report). Measures three domains of functional impairment: getting along with people, life activities (ability to carry out responsibilities at home and school), and participation in society (ability to engage in community, civil and recreational activities). Subscales are averaged to produce a Global Disability score. Scores are expressed as a percentage so range from 0-100, with higher scores indicating greater impairment.

  Baseline (pre-treatment)

• World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): caregiver report

  WHODAS-child orginally adapted for Rwanda and then translated into Arabic for use with Syrian children (caregiver report). Measures three domains of functional impairment: getting along with people, life activities (ability to carry out responsibilities at home and school), and participation in society (ability to engage in community, civil and recreational activities). Subscales are averaged to produce a Global Disability score. Scores are expressed as a percentage so range from 0-100, with higher scores indicating greater impairment.

  Approximately 12 weeks (immediately after treatment has been completed)

• World Health Organization Disability Assessment Schedule for Children (WHODAS-Child, adapted): caregiver report

  WHODAS-child orginally adapted for Rwanda and then translated into Arabic for use with Syrian children (caregiver report). Measures three domains of functional impairment: getting along with people, life activities (ability to carry out responsibilities at home and school), and participation in society (ability to engage in community, civil and recreational activities). Subscales are averaged to produce a Global Disability score. Scores are expressed as a percentage so range from 0-100, with higher scores indicating greater impairment.

  Approximately 24 weeks (3 months following completion of treatment)

Secondary Outcomes (23)

• Child PTSD Symptom Scale (CPSS)

  Baseline (pre-treatment)

• Child PTSD Symptom Scale (CPSS)

  Approximately 12 weeks (immediately after treatment has been completed)

• Child PTSD Symptom Scale (CPSS)

  Approximately 24 weeks (3 months following completion of treatment)

• Center for Epidemiological Studies Depression Scale for Children (CES-DC)

  Baseline (pre-treatment)

• Center for Epidemiological Studies Depression Scale for Children (CES-DC)

  Approximately 12 weeks (immediately after treatment has been completed)

Study Arms (2)

t-CETA

EXPERIMENTAL

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.

Behavioral: t-CETA

Médecins du Monde treatment as usual

ACTIVE COMPARATOR

Treatment as usual provided by Médecins du Monde. The number and content of sessions will vary depending on the needs of the child.

Behavioral: Médecins du Monde treatment as usual

Interventions

t-CETA BEHAVIORAL

Cognitive Behavioural Therapy (CBT) based approach delivered over the telephone. Components are available for common problems, including anxiety, depression, PTSD, conduct problems, substance abuse, and safety issues (including self-harm or suicidal ideation), and a tailored treatment package is produced for each child based on the presenting problem(s) and response to treatment. There are components for use with both child and caregiver.

Also known as: Telephone-delivered Common Elements Treatment Approach

t-CETA

Médecins du Monde treatment as usual BEHAVIORAL

Case manager-led care, with 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) vary.

Médecins du Monde treatment as usual

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 8-17 years, male or female
• Live with a parent or other legal guardian
• Child and/or parent identifies that the child has mental health difficulties and requests services
• 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 \[Criterion 4 is only applicable to children for whom these data are available from participation in the BIOPATH study; Criterion 5 takes precedence over Criterion 4 where both are available\]
• 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
• Parent/legal guardian gives informed consent and child gives assent to take part

You may not qualify if:

• 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)
• Parent or legal guardian is not able to provide consent

Sponsors & Collaborators

• Queen Mary University of London: lead
• Médecins du Monde: collaborator
• American University of Beirut Medical Center: collaborator
• Johns Hopkins University: collaborator
• Medical School Hamburg: collaborator

Study Sites (1)

Medecins du Monde

Beirut, Lebanon

Location

Related Publications (6)

• Murray LK, Dorsey S, Haroz E, Lee C, Alsiary MM, Haydary A, Weiss WM, Bolton P. A Common Elements Treatment Approach for Adult Mental Health Problems in Low- and Middle-Income Countries. Cogn Behav Pract. 2014 May;21(2):111-123. doi: 10.1016/j.cbpra.2013.06.005.

  PMID: 25620867 BACKGROUND

• Murray LK, Hall BJ, Dorsey S, Ugueto AM, Puffer ES, Sim A, Ismael A, Bass J, Akiba C, Lucid L, Harrison J, Erikson A, Bolton PA. An evaluation of a common elements treatment approach for youth in Somali refugee camps. Glob Ment Health (Camb). 2018 Apr 25;5:e16. doi: 10.1017/gmh.2018.7. eCollection 2018.

  PMID: 29868236 BACKGROUND

• Bolton P, Lee C, Haroz EE, Murray L, Dorsey S, Robinson C, Ugueto AM, Bass J. A transdiagnostic community-based mental health treatment for comorbid disorders: development and outcomes of a randomized controlled trial among Burmese refugees in Thailand. PLoS Med. 2014 Nov 11;11(11):e1001757. doi: 10.1371/journal.pmed.1001757. eCollection 2014 Nov.

  PMID: 25386945 BACKGROUND

• Weiss WM, Murray LK, Zangana GA, Mahmooth Z, Kaysen D, Dorsey S, Lindgren K, Gross A, Murray SM, Bass JK, Bolton P. Community-based mental health treatments for survivors of torture and militant attacks in Southern Iraq: a randomized control trial. BMC Psychiatry. 2015 Oct 14;15:249. doi: 10.1186/s12888-015-0622-7.

  PMID: 26467303 BACKGROUND

• Pluess M, McEwen FS, Biazoli C, Chehade N, Bosqui T, Skavenski S, Murray L, Weierstall-Pust R, Bolton P, Karam E. Delivering therapy over telephone in a humanitarian setting: a pilot randomized controlled trial of common elements treatment approach (CETA) with Syrian refugee children in Lebanon. Confl Health. 2024 Sep 20;18(1):58. doi: 10.1186/s13031-024-00616-2.

  PMID: 39304918 DERIVED

• McEwen FS, El Khatib H, Hadfield K, Pluess K, Chehade N, Bosqui T, Skavenski S, Murray L, Weierstall-Pust R, Karam E, Pluess M. Feasibility and acceptability of phone-delivered psychological therapy for refugee children and adolescents in a humanitarian setting. Confl Health. 2024 Jan 13;18(1):7. doi: 10.1186/s13031-023-00565-2.

  PMID: 38218936 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Conduct Disorder; Oppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Officials

• Michael Pluess, PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not be blind to treatment allocation. The team providing treatment and conducting in-session assessments will not be blind to treatment allocation. One individual will be responsible for processing raw data and hence will not be blind as to treatment allocation. The team carrying out independent assessments will be blind to treatment allocation. The investigator team carrying out data analysis will be blind to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Developmental Psychology, Head of Psychology Department

Model Details: There are two arms in the RCT, t-CETA and treatment as usual (TaU), to which children will be randomly assigned. A stratified randomization model will be used, with randomization occurring within four separate 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 A third group will consist of participants who do not wish to be randomised, but who will receive t-CETA. Their data will not form part of the RCT but will be used to provide additional data on efficacy, implementation, and acceptability of t-CETA.

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: March 22, 2019
• Study Start: May 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)