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Randomized Control Trial on Trauma Focused CBT in Zambia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01624298
Enrollment
257
Registered
2012-06-20
Start date
2012-08-31
Completion date
2014-03-31
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Post Traumatic Stress Disorder, Risk Behaviors

Keywords

Randomized controlled trial, Traumatized youth, HIV risk

Brief 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 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.

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.

Interventions

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.

Sponsors

Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Post Traumatic Stress Disorder- Reaction Index (RI)Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.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.

Secondary

MeasureTime frameDescription
Risk Reduction as Assessed by the World AIDS Foundation (WAF) Risk Reduction ScaleBaseline and follow-up within one month of treatment completion. For controls follow up was done 4 months post baseline.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.
Child Behavior Checklist (CBCL) ScoreBaseline and follow-up within one month of treatment completion. For controls follow up was done 4 months post baseline.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.

Countries

Zambia

Participant flow

Recruitment details

Recruitment began August 15, 2012 and ran until August 1, 2013. Recruitment was done at 5 community organizations located in Lusaka Zambia.

Participants by arm

ArmCount
Wait List Control Group
The 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.
126
Intervention Group
Children randomized into the intervention group will immediately receive the Trauma Focused Cognitive Behavioral Therapy with a trained counselor for 12 weeks. Trauma Focused Cognitive Behavioral Therapy: 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.
131
Total257

Baseline characteristics

CharacteristicWait List Control GroupIntervention GroupTotal
Age, Categorical
<=18 years
121 Participants122 Participants243 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
5 Participants9 Participants14 Participants
Age, Continuous13.29 years
STANDARD_DEVIATION 2.99
14.02 years
STANDARD_DEVIATION 2.78
13.66 years
STANDARD_DEVIATION 2.9
Region of Enrollment
Zambia
126 participants131 participants257 participants
Sex: Female, Male
Female
65 Participants63 Participants128 Participants
Sex: Female, Male
Male
61 Participants68 Participants129 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1260 / 131
serious
Total, serious adverse events
0 / 1260 / 131

Outcome results

Primary

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Wait List Control GroupPost Traumatic Stress Disorder- Reaction Index (RI)Baseline1.75 trauma scoreStandard Deviation 0.44
Wait List Control GroupPost Traumatic Stress Disorder- Reaction Index (RI)Post Assessment1.38 trauma scoreStandard Deviation 0.66
Intervention GroupPost Traumatic Stress Disorder- Reaction Index (RI)Baseline1.88 trauma scoreStandard Deviation 0.51
Intervention GroupPost Traumatic Stress Disorder- Reaction Index (RI)Post Assessment0.34 trauma scoreStandard Deviation 0.43
Secondary

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.

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

Population: Only participants with complete data were included in this analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Wait List Control GroupChild Behavior Checklist (CBCL) ScoreBaseline36.8 score on a scaleStandard Deviation 13
Wait List Control GroupChild Behavior Checklist (CBCL) ScorePost Assessment2.4 score on a scaleStandard Deviation 5.4
Intervention GroupChild Behavior Checklist (CBCL) ScoreBaseline77.8 score on a scaleStandard Deviation 48.7
Intervention GroupChild Behavior Checklist (CBCL) ScorePost Assessment15.8 score on a scaleStandard Deviation 14.6
Secondary

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.

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

Population: Only participants with complete data were included in this analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Wait List Control GroupRisk Reduction as Assessed by the World AIDS Foundation (WAF) Risk Reduction ScaleBaseline0.7 score on a scaleStandard Deviation 0.4
Wait List Control GroupRisk Reduction as Assessed by the World AIDS Foundation (WAF) Risk Reduction ScalePost Assessment0.8 score on a scaleStandard Deviation 0.4
Intervention GroupRisk Reduction as Assessed by the World AIDS Foundation (WAF) Risk Reduction ScaleBaseline0.9 score on a scaleStandard Deviation 0.1
Intervention GroupRisk Reduction as Assessed by the World AIDS Foundation (WAF) Risk Reduction ScalePost Assessment0.2 score on a scaleStandard Deviation 0.2

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026