Child Mental DisorderNCT03075475
Effectiveness Study of a Treatment to Improve the Mental Health of Children and Adolescents
A study testing Common Elements Treatment Approach in people with Child Mental Disorder and Behavior Problem, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Burma.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Mental Disorder, Behavior Problem
- What is being tested?
- Common Elements Treatment Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteBurma
- Study dates
- 1 Jun 2017to 8 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Moderately or severely affected (cutoff to be defined during validation phase) children ages 8-17 years.
Who cannot join
- Active psychosis or serious developmental disorder (e.g., mental retardation, autism) that would preclude participation in cognitive-behavioral oriented skills intervention
Trial locations and contacts
1 site in 1 country.
Burma1 site
Kachin Baptist Convention Jan Mai Kawng Camp
Myitkyina, Kachin State, 101
About this study
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
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.
Read the 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.
- Conditions
- Child Mental Disorder, Behavior Problem
- Being tested
- Common Elements Treatment Approach
- Keywords
- Child, Adolescent, Mental Health, Randomized Controlled Trial
- Medical subject headings
- Neurodevelopmental Disorders, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common Elements Treatment ApproachBehavioural
Also called CETA
The Common Elements Treatment Approach (CETA), is a trans-diagnostic psychotherapy that is based on common evidence-based treatments for depression, anxiety, trauma and stress related disorders. This treatment can be used to treat individuals with any of these mental health problems and with any combination of these problems. CETA expands upon traditional treatment approaches that are designed to focus on one specific disorder and has been proven through multiple rigorous trials to reduce the burden of multiple common mental health problems and improve functionality among men and women living in low resource settings. CETA can be provided to people in their own communities by trained and supervised lay providers, for example community health workers.
| Study group | Role | What they receive |
|---|---|---|
| CETA Treatment | Experimental | For treatment group participants, they will then have weekly Common Elements Treatment Approach (CETA) counseling sessions with a counselor lasting no more than 1.5 hours per session, and a total of approximately 10-12 sessions. They will then repeat the assessment instrument after their last session, as well as 6 months after finishing treatment, and these meetings will again last no more than 1.5 hours. All total, it is expected that treatment group participants will have 13 meetings with a study team member or counselor over the course of their participation. Receives: Behavioral: Common Elements Treatment Approach |
| Waitlist | No intervention | Waitlist group participants be contacted by a study team member from the local partner organization regularly (weekly) while they are on the wait list. These contacts from the study team will be short and last less than 30 minutes and will be used to briefly assess symptom levels and safety. At the end of their wait period, they will be asked to complete the assessment instrument a second time and this meeting will take no more than 1.5 hours. For participants in the waitlist group, we estimate 13 meetings total during their wait period (2 meetings of no more than 1.5 hours, 10 contacts less than 30 minutes). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (2)
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".
Measured: 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.
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".
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start1 Jun 2017
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Why it stopped: Very few children and adolescents identified who met intake criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child Mental DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Catherine Lee, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075475
- Sponsor's protocol ID
- 00007317
- Status last verified
- Jun 2018
- First submitted
- 6 Mar 2017
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25386945
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03075475
- Acronym / sponsor ID
- 00007317
- Conditions
- Child Mental Disorder, Behavior Problem
- Keywords
- Child, Adolescent, Mental Health, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very few children and adolescents identified who met intake criteria.
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CETA Treatment | Experimental | Behavioral: Common Elements Treatment ApproachFor treatment group participants, they will then have weekly Common Elements Treatment Approach (CETA) counseling sessions with a counselor lasting no more than 1.5 hours per session, and a total of approximately 10-12 sessions. They will then repeat the assessment instrument after their last session, as well as 6 months after finishing treatment, and these meetings will again last no more than 1.5 hours. All total, it is expected that treatment group participants will have 13 meetings with a study team member or counselor over the course of their participation. |
| Waitlist | No intervention | –Waitlist group participants be contacted by a study team member from the local partner organization regularly (weekly) while they are on the wait list. These contacts from the study team will be short and last less than 30 minutes and will be used to briefly assess symptom levels and safety. At the end of their wait period, they will be asked to complete the assessment instrument a second time and this meeting will take no more than 1.5 hours. For participants in the waitlist group, we estimate 13 meetings total during their wait period (2 meetings of no more than 1.5 hours, 10 contacts less than 30 minutes). |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Moderately or severely affected (cutoff to be defined during validation phase) children ages 8-17 years.
Key exclusion criteria (1 listed)
- Active psychosis or serious developmental disorder (e.g., mental retardation, autism) that would preclude participation in cognitive-behavioral oriented skills intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Common Elements Treatment ApproachAlso: CETAThe Common Elements Treatment Approach (CETA), is a trans-diagnostic psychotherapy that is based on common evidence-based treatments for depression, anxiety, trauma and stress related disorders. This treatment can be used to treat individuals with any of these mental health problems and with any combination of these problems. CETA expands upon traditional treatment approaches that are designed to focus on one specific disorder and has been proven through multiple rigorous trials to reduce the burden of multiple common mental health problems and improve functionality among men and women living in low resource settings. CETA can be provided to people in their own communities by trained and supervised lay providers, for example community health workers. | Behavioural | CETA Treatment |
Primary outcome
Change in child mental health scores from composite measure
Time frame: 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.
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.
2 secondary outcomes
Change in child behavior problem scores
Time frame: 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.
Change in child functional impairment
Time frame: 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.
Results and safety
The study was stopped early (reason given: Very few children and adolescents identified who met intake criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Background: PubMed 25386945Bolton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Lee, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Common Elements Treatment Approach in people with Child Mental Disorder and Behavior Problem, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Burma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burma. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Very few children and adolescents identified who met intake criteria.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child mental health scores from composite measure (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.