Clinical trial NCT03075475: Effectiveness Study of a Treatment to Improve the Mental Health of Children and Adolescents
Official title: Study of Effectiveness of a Treatment to Improve the Mental Health of Children and Adolescents Affected by Armed Conflict in Kachin State, Myanmar
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Child Mental Disorder
Behavior Problem
Keywords: Child
Adolescent
Mental Health
Randomized Controlled Trial
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2017-03-09
Enrollment: 83
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial evaluates the effectiveness of a psychotherapeutic intervention, the Common Elements Treatment Approach (CETA), to address the mental health needs of children and adolescents age 8-17 who have been affected by armed conflict in Kachin State, Myanmar. The 10-12 week talk-based counseling treatment, delivered by community mental health workers, will be evaluated against a wait-list control group. This project follows on a recently completed trial of CETA for adult trauma survivors from Myanmar along the Thai-Myanmar border which found that CETA was acceptable, accessible, and effective in improving mental health and functioning of adults. The investigators hypothesize that the intervention will be similarly effective for improving the mental health and functioning of children and adolescents.

Detailed description: The Common Elements Treatment Approach (CETA) is a trans-diagnostic psychotherapeutic intervention.

Results from qualitative interviews following the randomized controlled trial (RCT) of CETA for adults (IRB # 00003601) and during the scale-up of CETA services have indicated that there is a major need for mental health services for children and adolescents in Myanmar, as currently there are no evidence-based psychotherapy services for children and adolescents in the country. Specifically, since the initial trial the research team has received requests from community-based organizations to implement CETA for children and adolescents in Kachin language-speaking communities in northern Myanmar. Local partners and the Applied Mental Health Research group (AMHR) at Johns Hopkins University (JHU) believe that CETA is amenable for use with children and adolescents and that this population would benefit in similar ways to adults. A qualitative study has since been conducted (IRB# 00006933), and the data used to develop and validate an assessment instrument with children and adolescents in Kachin state (IRB# 00006929).

The JHU research team will work with the local partner organization, Kachin Baptist Convention (KBC), to implement this project. KBC is a well-established community-based organization that currently provides emergency relief services to approximately 20,000 displaced Kachin people living in 42 camps. Their community outreach activities are non-denominational.

Participants will mostly be accessed through schools and in partnership with the local implementing partner. Their teachers, secondary caregivers and persons from the local partner organization who work with them regularly - all of whom are involved in the study as key community informants - will identify and refer the potential child/adolescent participants for screening into the study. Screening will otherwise be open to all children/adolescents, and those who are eligible will be asked to participate in the trial. Informed consent will be obtained from the parent/guardian and informed assent from the child. Participants will be randomly assigned to either receive CETA immediately or be put on a waitlist to receive treatment later.

Counselors will be current employees of the local partner organization who have participated in a 2-week initial training followed by 8-10 weeks of supervised practice. Counselors will receive weekly clinical supervision for the duration of the trial.

During the RCT, 10-12 weekly CETA sessions will be delivered individually in private spaces either at schools, homes, or in the community. In most cases, the children are living in the camps with their parents/guardians. Counselors will also follow-up with control children on a weekly basis to assess their symptoms using a client monitoring form. Both treatment and control participants will be reassessed using the same assessment instrument following the treatment period.

Eligibility criteria: Inclusion Criteria:

* Moderately or severely affected (cutoff to be defined during validation phase) children ages 8-17 years.

Exclusion Criteria:

* Active psychosis or serious developmental disorder (e.g., mental retardation, autism) that would preclude participation in cognitive-behavioral oriented skills intervention

Primary outcomes:
measure: Change in child mental health scores from composite measure
timeFrame: The time between pre- and post-test intervention assessment will be 8-12 weeks for treatment group (according to the number of CETA sessions) and 10 weeks for wait list participants.
Secondary outcomes:
measure: Change in child behavior problem scores
timeFrame: The time between pre- and post-test intervention assessment will be 8-12 weeks for treatment group (according to the number of CETA sessions) and 10 weeks for wait list participants.
measure: Change in child functional impairment
timeFrame: The time between pre- and post-test intervention assessment will be 8-12 weeks for treatment group (according to the number of CETA sessions) and 10 weeks for wait list participants.
Other outcomes:
Locations:
city: Myitkyina
country: Myanmar
facility: Kachin Baptist Convention Jan Mai Kawng Camp
state: Kachin
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Catherine Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.