Trial Outcomes & Findings for Randomized Control Trial on Trauma Focused CBT in Zambia (NCT NCT01624298)
NCT ID: NCT01624298
Last Updated: 2024-08-09
Results Overview
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.
COMPLETED
NA
257 participants
Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.
2024-08-09
Participant Flow
Recruitment began August 15, 2012 and ran until August 1, 2013. Recruitment was done at 5 community organizations located in Lusaka Zambia.
Participant milestones
| Measure |
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.
|
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) 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.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
131
|
|
Overall Study
COMPLETED
|
104
|
106
|
|
Overall Study
NOT COMPLETED
|
22
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Control Trial on Trauma Focused CBT in Zambia
Baseline characteristics by cohort
| Measure |
Wait List Control Group
n=126 Participants
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.
|
Intervention Group
n=131 Participants
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.
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.29 years
STANDARD_DEVIATION 2.99 • n=99 Participants
|
14.02 years
STANDARD_DEVIATION 2.78 • n=107 Participants
|
13.66 years
STANDARD_DEVIATION 2.90 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
121 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
243 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Region of Enrollment
Zambia
|
126 participants
n=99 Participants
|
131 participants
n=107 Participants
|
257 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Wait List Control Group
n=104 Participants
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.
|
Intervention Group
n=106 Participants
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.
|
|---|---|---|
|
Post Traumatic Stress Disorder- Reaction Index (RI)
Baseline
|
1.75 trauma score
Standard Deviation 0.44
|
1.88 trauma score
Standard Deviation 0.51
|
|
Post Traumatic Stress Disorder- Reaction Index (RI)
Post Assessment
|
1.38 trauma score
Standard Deviation 0.66
|
0.34 trauma score
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Wait List Control Group
n=10 Participants
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.
|
Intervention Group
n=4 Participants
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.
|
|---|---|---|
|
Risk Reduction as Assessed by the World AIDS Foundation (WAF) Risk Reduction Scale
Baseline
|
0.7 score on a scale
Standard Deviation 0.4
|
0.9 score on a scale
Standard Deviation 0.1
|
|
Risk Reduction as Assessed by the World AIDS Foundation (WAF) Risk Reduction Scale
Post Assessment
|
0.8 score on a scale
Standard Deviation 0.4
|
0.2 score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Wait List Control Group
n=5 Participants
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.
|
Intervention Group
n=8 Participants
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.
|
|---|---|---|
|
Child Behavior Checklist (CBCL) Score
Baseline
|
36.8 score on a scale
Standard Deviation 13.0
|
77.8 score on a scale
Standard Deviation 48.7
|
|
Child Behavior Checklist (CBCL) Score
Post Assessment
|
2.4 score on a scale
Standard Deviation 5.4
|
15.8 score on a scale
Standard Deviation 14.6
|
Adverse Events
Wait List Control Group
Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place