Effectiveness Study of a Treatment to Improve the Mental Health of Children and Adolescents

NCT03075475 | Terminated

• 1 other identifier: 00007317
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Mental Disorder; Behavior Problem

Keywords

Child; Adolescent; Mental Health; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in child behavior problem scores

  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

  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.

Study Arms (2)

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.

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).

Interventions

Common Elements Treatment Approach BEHAVIORAL

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.

Also known as: CETA

CETA Treatment

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Kachin Baptist Convention Jan Mai Kawng Camp

Myitkyina, Kachin State, 101, Burma

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Neurodevelopmental Disorders; Mental Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Catherine Lee, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 9, 2017
• Study Start: June 1, 2017
• Primary Completion: January 8, 2018
• Study Completion: January 8, 2018
• Last Updated: July 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)