Behavior Problem Clinical Trial
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
NCT number | NCT03075475 |
Other study ID # | 00007317 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | January 8, 2018 |
Verified date | June 2018 |
Source | Johns Hopkins Bloomberg School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 83 |
Est. completion date | January 8, 2018 |
Est. primary completion date | January 8, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Myanmar | Kachin Baptist Convention Jan Mai Kawng Camp | Myitkyina | Kachin |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins Bloomberg School of Public Health | United States Agency for International Development (USAID) |
Myanmar,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in child mental health scores from composite measure | Self-reported child mental health symptoms will be measured using a modified, locally validated version of the assessment instrument consisting of 23 items from 1) the Child PTSD Symptom Scale (CPSS); 2) and the Moods and Feelings Questionnaire (MFQ); and 3) items developed from qualitative research in this population. Respondents report how often each problem has bothered him/her in the past two weeks. Response options range from 0 "none of the time" to 3 "almost all of the time". Results will be reported as a single value from this composite outcome measure consisting of multiple measures. | 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 | Change in child behavior problem scores | Self-reported child behavior problems will be assessed using a behavior problem checklist developed using qualitative data collected from this population. Respondents report how often they have done or experienced each behavior in the past two weeks. Response options range from 0 "none of the time" to 3 "almost all of the time". | 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 | Change in child functional impairment | Self-reported child functional impairment will be assessed using a functioning scale developed using qualitative data collected from this population. Respondents report how much difficulty they currently have doing tasks of daily living. Response options range from 0 "no difficulty" to 3 "often cannot do". | 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. |
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