Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02054780 |
| Other study ID # |
5R01HD070720 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 17, 2013 |
| Last updated |
April 4, 2018 |
| Start date |
February 2014 |
| Est. completion date |
November 2017 |
Study information
| Verified date |
April 2018 |
| Source |
Johns Hopkins Bloomberg School of Public Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to compare the effectiveness of two types of counseling,
Psychosocial Counseling (PC) and Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), in
addressing outcomes of orphans and vulnerable children (OVC) including mental and behavioral
health, well-being, social support, and HIV risk behaviors. The study will be conducted in
Lusaka, Zambia.
Description:
This is a randomized controlled trial to evaluate the effectiveness of TF-CBT compared to PC
in improving a range of OVC outcomes including HIV risk behaviors but also mediating factors
which constitute important outcomes - well-being, mental health, functioning, and caregiver
health and support. The study design also includes measurement of the impact of factors that
may moderate effects - age, gender, religion, ethnicity, HIV knowledge and attitudes,
education, and physical health. This is an effectiveness trial in that the interventions will
be provided by Ministry of Health (MoH) and organizations already providing services to OVC.
Assessments: Study instruments will be administered using an Audio Computer Assisted
Self-Interviewing (ACASI) system developed by Tufts University. The Tufts ACASI system allows
the responder control to navigate and answer sensitive questions privately and discreetly. It
was developed using Macromedia Authorware (v7.0) and can be programmed in any language by
having a native speaker record the screen text. The Tufts ACASI system offers both live
interview and data entry modes and can deliver a variety of question types, including yes/no,
single-answer multiple choice (select one answer), and multiple-answer multiple choice
(select all that apply) questions which allow numeric keypad entry, as well as scale
questions which allow the user to click on a point along a scale, and text entry for
interviewer-administered, open-ended questions
Procedure: Study participants will be recruited via several methods. The first method of
recruitment is from urban communities through outreach by existing Home Based Care Workers
(HBCWs) and other peer educators under the Archdiocese of Lusaka, local churches, and other
local organizations that have outreach activities in the community. The HBCWs and peer
educators will introduce the study to families in the community who they believe may be
eligible for the study. Investigators will also ask these peer educators and HBCWs to use a
recruitment script to introduce the study to both the adolescent and his/her caretaker. If
the adolescent and/or caretaker are not interested in hearing more about the study, their
information will not be passed on to study staff and we will have no contact with that
family. The HBCW will make follow-up appointments with families who are interested in hearing
more about the study and arrange a time for them to go to a local parish. At these follow-up
appointments one of the study assessors will discuss the study in detail with the potential
participants (adolescent and caretaker). This is preferable to clinic-based recruitment
because, 1) many OVC do not come to clinics for reasons such as stigma, fear, mental health
problems or transport problems 2) HBCWs will assist with retention, and 3) study staff will
have no contact with any families who have not already indicated to their HBCW that they
would like to hear more about the study
As a second recruitment strategy, investigators will also hold general community meetings in
each of the study sites in which all members of the community will be invited. Investigators
will explain the general purpose of the study at these meetings and answer any questions.
Investigators will invite families to contact us directly if they are interested in hearing
more about the study from one of our study assessors or to talk with their HBCW who can put
the family in touch with our research staff. The community will also be given specific dates
when the study team will be at a central parish where they may come to be assessed and/or ask
additional questions.
Third, we may use a school-based recruitment. For this strategy investigators will first hold
meetings with school officials (e.g., Principals, head teachers) in schools within our
catchment area in Lusaka. Investigators will also gain approval from the Ministry of
Education of Zambia if needed. Investigators will also hold general meetings at the school
open to all staff, students, and parents to let them know about the study. If the school
officials agree to have recruitment in the school, investigators will ask that they introduce
guidance counselors. Investigators will train the guidance counselors in the school, who have
knowledge of which students in the school might be eligible for the study, on the purpose of
the study and how to introduce the study to families that they believe would be eligible.
Meet with head teacher, explain study. Also talks to other staff members. Guidance counselor
would meet with the parents and child to see if they are interested. Additionally, we will
provide our study contact information at the general school meeting so that interested
families may contact us directly. Investigators will have study staff on-site on selected
days to meet privately with interested families for explaining the study in full, obtaining
informed consent, and proceeding with study activities.
Fourth, investigators will use a snowball sampling strategy. A large number of adolescents
and caregivers enrolled in the study have informed us that they know other families in their
communities they think would benefit from mental health and psychosocial services.
Investigators plan to have counselors ask current study participants if they know of specific
families who they think would be interested in hearing more about the study. If participants
know other families who they think would be interested, investigators will ask the
participants to bring those families to meet with the counselor. The counselor will then give
a brief introduction to the study. The counselor will then refer families who are still
interested to the research team and a day/time will be setup for the family to privately meet
with an assessor for consenting and screening as per the original study protocol.
The assessors will be at the parish locations, or if needed would go with an HBCW (if an HBCW
was involved in the recruitment) to the families' homes that indicated interest in the study.
The assessor will conduct the adult consent and caretaker permission process with the
caretaker first. Consent and permission will be obtained at this time for all parts of the
study-- screening, interview using ACASI, and intervention. In all cases, the caretaker will
have to provide consent to participate in the interview and intervention for him/herself and
will also have to provide permission for the adolescent to participate in the screening,
interview, and intervention. For these cases, in the response section the assessor will
indicate if the caretaker consents to participate in each of the sections
(screening/interview and intervention) separately and gives permission for their adolescent
to participate in each of the 3 sections (screener, interview and intervention) separately.
If the caregiver and child respond yes to the consent and the caretaker provides permission
for the adolescent, the assessor will administer the screener. This screener will be scored
immediately and if the child is determined eligible for the study, the assessor will ask if
they are able to complete the full assessment battery at this time (approximately 2 hours) or
if they would like to schedule a separate time to complete this. If a separate time/date is
preferred, the assessor will schedule that with the family. The HBCW will not be present
during the consent or assessment process.
If the adolescent is found to be eligible after the screening interview (through the results
of either the adolescent screening, caretaker screening, or both), then the assessor will
allocate a study ID number to the adolescent. When the baseline is designated to be
completed, the assessor will set up two notebook computers for the baseline interview: one
for the adolescent and one for the caretaker. The adolescent and caretaker will complete the
interview simultaneously but separately (in separate rooms), with the assessor not present
but close by in case of problems or questions. On completion of the baseline interview the
assessor will let the family know that someone from their nearest MoH clinic will contact
them.
At the end of each day all assessors will report the allocated study IDs to the on-site Study
Director, who will send them to a Johns Hopkins-based research staff who will retain the
confidential master list linking study IDs to interventions based on random assignment. The
Johns Hopkins researcher will respond with the allocations for those study IDs. These data
will be used to inform the clinics which intervention each new participant will receive prior
to their first visit. Both interventions will be available at all study sites. Neither
assessor, caretaker, nor adolescent will know which intervention the adolescent will receive.
Whether or not an adolescent agrees to join the study s/he will have access to other services
under the Archdiocese of Lusaka. These services include Psychosocial Counseling, Home Based
Care services, medical and education support, voluntary counseling and testing (VCT),
Community Sensitization Campaigns, Behavioral Change, livelihood support, tuberculosis care,
awareness programs on communicable diseases. The adolescent will also have access to the HIV
prevention strategies available at the MoH clinics including, VCT, counseling, safe sex
interventions and primary care services. For those in the study, we will monitor utilization
of these services and include that information as a variable in the analysis, to determine
their effects as potential moderators of treatment effects.
The adolescent will either go to a MoH clinic or a different, pre-identified community center
for their first appointment with their counselor to receive either TF-CBT or PC. Later
sessions will either be at the clinic or at another location that the counselor and family
agree on, and locations can vary from week to week if necessary and feasible. The caretaker
may also participate in these sessions (if they have consented to participate in the study
along with the adolescent). Because the Archdiocese of Lusaka sites are deeply embedded into
the community, other neighborhood structures—such as churches—may be used as meeting points.
Follow-up Assessments with both adolescent and caretaker will be done at 0 and 6 months after
completion of the interventions. The 6 month time point is considered the primary time point
of interest. If one treatment shows substantially greater efficacy at 6 months it will be
offered to those that received the other intervention and a 12 month assessment will be done
only with the group originally allocated to the more effective intervention.
We expect to have 3-4 study contacts with research participants and their caregivers:
1. Baseline interview
2. Follow-up at 0 months
3. Follow-up interview at 6 months
4. Follow-up interview at 12 months.
The outcomes for Specific Aim 1 are indicators of HIV risk behaviors. This includes questions
about social circles engaging in risky sexual behaviors such as multiple sexual partners,
having sex without a condom, sexually transmitted infections (STIs) and substance use (HIV
risk assessment screening tool). The WAF instrument will also assess broader HIV risk
indicators such as knowledge, attitudes, self-efficacy and sexual practices. The outcomes for
Specific Aim 2 are the scores on various mental health and well-being tests, including Child
PTSD Symptom Scale (CPSS), Child Behavior Checklist (CBCL), self-perception, Achenbach Youth
Self Report, ASSIST (substance use), and functionality.
All primary analyses will be based on an intent-to-treat approach. For all continuous
outcomes, linear mixed models will model each outcome over time by incorporating a random
intercept term and possibly a random slope term to account for within subject correlation on
repeated measures. The test scores at completion of intervention and at 6 and 12 months after
completion will be modeled separately using treatment arm, baseline symptom score, time, and
an interaction between each treatment arm and time as fixed covariates in each model. This
analysis will allow estimation of the mean difference in each symptomatology score between
the two treatment arms at each time, adjusting for baseline score if needed. Mean differences
and 95% confidence intervals will be calculated and presented. For dichotomous variables, a
generalized linear mixed effects models will be used. A risk ratio and 95% confidence
interval comparing each binary outcome between the two arms at each time will be reported.
Potential modifiers and mediators will be handled as described below.
Moderator and mediator analyses: The study will evaluate the impact of hypothesized
moderators (child age, gender, religion, ethnicity, HIV knowledge and attitudes, family
formation, education, physical health) on treatment response. We have also hypothesized that
changes in the course of therapy in caregiver levels of distress and support and changes in
the child's mental health and self-perception will mediate the impact of treatment on
children's outcomes.
All of the significant moderating and mediating variables then will be simultaneously entered
into multiple regression analyses with respect to the individual outcome measures to
ascertain which variables contribute unique variance to estimating the outcome variables.
Significant moderators and mediators will then be tested for specific treatment effects using
multiple linear-regression analyses. Multiple regression techniques will examine the pattern
of relationships between treatment, hypothesized mediating influences and outcomes. Using the
steps suggested by Baron and Kenny, we will examine whether a) each treatment arm
significantly predicts mediator; b) mediator significantly predicts symptom outcome; and c)
whether the significant relationship between each treatment condition and symptom outcome
decreases significantly when the change in mediator is entered into the regression model.
In addition to primary analyses on the clinical effectiveness of the interventions, we will
also analyze cost effectiveness and implementation challenges.
Service use, employment-related and caregiver data will be collected for a retrospective
period of 3 months at baseline, and at 1 month, 6 months and 12 months post-treatment using a
version of the Client Service Receipt Inventory adapted for OVC. Service use and carer inputs
will be turned into cost measures by applying local and national unit cost values.
We will also monitor and evaluate system implementation factors, including acceptability,
adoption, appropriateness, feasibility, fidelity, penetration and sustainability from the
perspective of multiple stakeholders including, providers, organizations and policy leaders.
Semi-structured interviews will be conducted with these stakeholders to examine perspectives
on the barriers and facilitators of implementation.
