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Post Traumatic Stress DisorderNCT01624298

Randomized Control Trial on Trauma Focused CBT in Zambia

A study testing Trauma Focused Cognitive Behavioral Therapy in people with Post Traumatic Stress Disorder and Depression, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to study the effectiveness of Trauma Focused Cognitive Behavioral Therapy in subset of children who are affected by trauma with significant mental health symptomatology in order to 1) examine the effectiveness of TF-CBT in reducing the severity of mental health symptoms experienced by… Read more about this study

Who is it for?
Ages 5 to 18 yearsHealthy volunteers can take part
What is being tested?
Trauma Focused Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
1 siteZambia
Study dates
Aug 2012to Mar 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 5 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Youth found to exhibit significant trauma symptomatology as evidenced by a score of 38 or above on the previously validated PTSD-RI symptom scale (Murray, et al. 2011) (trauma severity is the main study outcome) will be invited to join the trial. Youth must live in Lusaka, Zambia.

Who cannot join

  • Youth currently receiving psychiatric care
  • Youth who are actively suicidal
  • Persons who are not mentally competent to give assent or whose legal guardians are not mentally competent to give consent to participate in the intervention

Trial locations and contacts

1 site in 1 country.

Zambia1 site
  • Serenity Harm Reduction Programme Zambia

    Lusaka, 10101

Other trials in Zambia

About this study

Official title: A Randomized Control Trial to Determine the Effectiveness of Trauma Focused Cognitive Behavioral (TF-CBT) Among Children in Lusaka, Zambia

The purpose of this study is to study the effectiveness of Trauma Focused Cognitive Behavioral Therapy in subset of children who are affected by trauma with significant mental health symptomatology in order to 1) examine the effectiveness of TF-CBT in reducing the severity of mental health symptoms experienced by traumatized children and adolescents in Lusaka and 2) determine the effectiveness of TF-CBT in reducing HIV risk taking behaviors and increasing coping strategies and health promotion activities in traumatized children and adolescents in Lusaka. The study will be integrated into current programing of the Serenity Harm Reduction Programme, a community and faith based organization focusing on mental health and substance use prevention and treatment, and its partners in 5 compounds.

Read the detailed description

In preparation for the trial, in February and March of 2012, a US-based clinical psychologist and expert trainer in TF-CBT traveled to Lusaka Zambia and trained 20 counselors in TF-CBT. This included supplemental training of the already established and trained national TF-CBT supervisors from SHARPZ and the University of Zambia (UNZA). Counselors will take on 1 practice case each in TF-CBT. Local supervisors will meet with the counselors in groups on a weekly basis to monitor the intervention and will be in regular phone and email contact to assist with the initiation of cases. The US-based TF-CBT experts (Drs. Murray and Dorsey) will be in contact with the supervisors on a weekly basis (via skype) to assist with the supervision and provide ongoing support to the supervisors and the counselors. This follows the Apprenticeship Model of Training and Supervision (Murray et al., 2011).

As part of the study, 11 assessors will be trained on a comprehensive intake assessment process. The process uses an adapted initial intake form that is currently used by the partner organization to collect basic demographic, health, and other information about the client and a parent or guardian and adds a standard mental health and functioning assessment instrument based on the earlier qualitative and quantitative research conducted by the Johns Hopkins University (JHU) faculty. All children age 5-8 enrolled in the study will receive the demographics section, the PTSD-RI and the Shame measures as well as section one of the World AIDS Foundation measure that covers the topics of HIV Testing and Substance Abuse. Children ages 12 years and older will also receive the World Aids Foundation (WAF) questionnaire section 2 that asks questions related self-efficacy and sexual relationships and violence. Only children ages 12 and older who report yes to having experienced sexual intercourse of any form will be asked section 3 of the WAF which includes questions related to their relationship with their partner, sexual behaviors and HIV-risk behaviors commonly connected to trauma and mental health symptoms. Adults participating in the study will be given a demographics section, a section related to services received and the Child Behavior Checklist (CBCL).

The proposed study will be embedded within the ongoing SHARPZ program. We will study the effectiveness of TF-CBT for children who are affected by trauma with significant mental health symptomatology. The partner organizations will continue to provide services to anyone who seeks their services regardless of whether they meet eligibility for our proposed study, however those who meet our inclusion criteria will be invited to participate in the research component of the SHARPZ service program.

Qualitative exit interviews: Following completion of the therapy by the first set of 20 participants, assessors will ask these intervention participants what has changed since the intervention began and what change they attribute to the intervention. Interviews will be open ended, written by the assessors (not tape recorded) and identifying information will not be recorded. The research team will review these qualitative exit interviews to identify any unexpected positive or negative effects of the intervention. Questions on the more significant and/or frequent responses will be added to the original assessment instrument.

Post-intervention quantitative assessments will be done with the expanded assessment instrument (see qualitative exit interviews above). All post intervention quantitative interviews (including with the wait controls) will be conducted approximately 2-3 weeks after the client has completed the intervention or control period (approximately 12-14 weeks). Those randomized to the intervention will also receive a second post assessment 4 months after receiving the first post assessment. Control cases will only receive one post assessment after the wait list period so that they may then receive the intervention, unless found to be harmful or ineffective, as soon as their wait list period is over.

Following completion of the trial, the data will be analyzed, and if the intervention is found to be effective, it will become a permanent part of the services provided by the counselors at SHARPZ and the partner organizations.

Being tested
Trauma Focused Cognitive Behavioral Therapy
Keywords
Randomized controlled trial, Traumatized youth, HIV risk
Medical subject headings
Stress Disorders, Post-Traumatic, Depression, Risk-Taking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trauma Focused Cognitive Behavioral TherapyBehavioural

    Also called TF-CBT

    TF-CBT (www.musc.edu/tfcbt) is a therapy that helps children/youth ages 5-18 years and their families who have been affected by traumatic events and/or traumatic grief. Components include psychoeducation, relaxation, affective modulation, cognitive processing, Trauma Narrative (gradual exposure), In-vivo exposure, Con-joint session, and Enhancing safety skills. Youth and caregivers are seen once a week for approximately 12 weeks.

Study groups in NCT01624298
Study groupRoleWhat they receive
Wait List Control GroupNo interventionThe wait list control group will be asked to wait for approximately 4 1/2 months before being reassessed and then, unless found to be ineffective or harmful, receive the intervention being provided by the counselor.
Intervention GroupExperimentalChildren randomized into the intervention group will immediately receive the Trauma Focused Cognitive Behavioral Therapy with a trained counselor for 12 weeks.
Receives: Behavioral: Trauma Focused Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post Traumatic Stress Disorder- Reaction Index (RI)

    The PTSD-RI assesses specific traumatic events a child has experienced or witnessed, and the associated mental health symptoms to such stressors. PTSD-RI can range from a score of 0 on the scale to a score of 4 on the scale. Higher scores are associated with greater symptomatology. The psychometric properties have been extensively demonstrated in the US and Internationally. The PTSD RI has also been translated into three local Zambian languages (Nyanja, Bemba and Tonga) and validated in Zambia in Johns Hopkins University faculty preliminary studies.

    Measured: Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.

Secondary outcomes (2)
  1. Risk Reduction as Assessed by the World AIDS Foundation (WAF) Risk Reduction Scale

    Potentially risky sexual activity and substance use and abuse will be measured using the World AIDS Foundation (WAF) survey Risk Reduction Scale, developed and used with adolescents in South Africa. This measure was adapted for use in Zambia. Score range 8-16. Higher scores indicate feeling more empowered to perform risk reduction intentions, higher scores indicate a better outcome.

    Measured: Baseline and follow-up within one month of treatment completion. For controls follow up was done 4 months post baseline.

  2. Child Behavior Checklist (CBCL) Score

    The CBCL consists of eight empirically-based syndrome subscales. The range of subscale scores (summed) are: Aggressive Behavior (0-36), Anxious/Depressed (0-26), Attention Problems (0-20), Rule-Breaking Behavior (0-34), Somatic Complaints (0-22), Social Problems (0-22), Thought Problems (0-30), and Withdrawn/Depressed (0-16). Score range 0-206. The higher score suggests the more severe symptoms.

    Measured: Baseline and follow-up within one month of treatment completion. For controls follow up was done 4 months post baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2013
  4. Study completionMar 2014

Resources

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
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01624298
Sponsor's protocol ID
TFCBTRCTDCOF
Status last verified
Feb 2024
First submitted
18 Jun 2012
Last updated
9 Aug 2024
Data monitoring committee
Yes

Publications

  • Murray LK, Skavenski S, Kane JC, Mayeya J, Dorsey S, Cohen JA, Michalopoulos LT, Imasiku M, Bolton PA. Effectiveness of Trauma-Focused Cognitive Behavioral Therapy Among Trauma-Affected Children in Lusaka, Zambia: A Randomized Clinical Trial. JAMA Pediatr. 2015 Aug;169(8):761-9. doi: 10.1001/jamapediatrics.2015.0580.

    PubMed 26111066

Questions about this trial

What is this clinical trial studying?

A study testing Trauma Focused Cognitive Behavioral Therapy in people with Post Traumatic Stress Disorder and Depression, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Zambia.

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 3 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: finished, as of the sponsor's last update on 9 Aug 2024. 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 Zambia. 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?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Post Traumatic Stress Disorder- Reaction Index (RI) (time frame: Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.). 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 NCT01624298, 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 9 Aug 2024.

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