Child MaltreatmentTFHEVALNCT02168985
Impact Evaluation Study of The Faithful House Programme on Violence Reduction in Families
A study testing TFH program in people with Child Maltreatment, run by Savannas Forever Tanzania at 1 site in Tanzania.
Trial summary
The Faithful House (TFH), is a 3-day faith-based skills-building curriculum which aims to increase household resilience by strengthening families. TFH draws on improved communication and conflict resolution skill building and the individual's faith-values as a catalyst for transformation in attitudes regarding gender… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Child Maltreatment
- What is being tested?
- TFH program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTanzania
- Study dates
- Jul 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both male and female partners in an HIV AIDS conflicted couple
- Has at least one child age 10 to 17 years living in couple's household
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Arusha Lutheran Medical Centre
Arusha, Arusha
John A Laiser, + 255 754761295, johnlaiser@yahoo.com
About this study
Official title: Impact Evaluation for the Faithful House Program in Reducing Violence in Families in Which Couples Are Discordant or HIV/AIDS Positive in Arusha Region, in Tanzania
The Faithful House (TFH), is a 3-day faith-based skills-building curriculum which aims to increase household resilience by strengthening families. TFH draws on improved communication and conflict resolution skill building and the individual's faith-values as a catalyst for transformation in attitudes regarding gender roles in care giving and the use of violence in the home. The study hypothesis is that couples who complete the Faithful House Programme will demonstrate increased communication skills with their spouses and children, which reduces the negative impact of family stress triggers and ultimately leads to a reduction of intimate partner violence witnessed by children as well as physical and emotional violence against children by parents.
The mixed methods study will include a Randomized Control Trial (RCT) of HIV/AIDS infected or conflicted couples and a child in each household, focus group discussions (FGD) of men, women and children and key informant interviews of local experts in family violence and social protection service network providers.
Read the detailed description
A mixed-method evaluation of The Faithful House is proposed. In the main, we will conduct a randomized control trial of the education program to determine treatment effect. We will also conduct semi-structured interviews and focus groups with stakeholders. This more qualitative work will be done in order to refine our program and evaluation and to assess the fidelity of the intervention and assess and unintended consequences. Informed consent will be sought from all prospective participants.
The source population is families that receive HIV care from Arusha Lutheran Medical Centre and Selian Hospital. Participation and related compliance is enhanced because subjects come to the hospital for HIV treatment. Couples with children ages 10 to 17 years will be recruited to participate in a Faithful House workshop and study by hospital volunteers. All patients attending the clinic during the recruiting period will be screened based on eligibility criteria. The list of patients screened will be checked against the clinic register to verify that all potential participants were screened and all eligible respondents were invited to participate in the workshop and study.
The list of recruited couples will be randomized to receive the intervention or to serve as the control arm. The control arm will be offered the intervention at the conclusion of the study. The goal is to have N=150 couples in the treatment arm and N=150 couples in the control arm. The rationale for the sample size is twofold. First, given the estimated variances from surveillance studies the sample size permits the estimates of small to moderate effect sizes at 80% power and 5% Type I error. In simple terms, the proposed evaluation is strongly powered to detect politically and clinically meaningful effects. Second, given time, budget, and patient flow characteristics, 300 couples is near the maximum of our capacity. Baseline measures will be taken via survey on all participants in a clinical setting about one month prior to beginning the education program. Post program measures will be taken in a clinical setting three months after the intervention is complete. A context-based pretest and post-test will be administered to only those in the treatment group on the first and last day of the intervention.
Gender and age specific surveys will be used to interview men, women and children and questions on self-reported violence will be included in women and children's questionnaires. Answers to questions on violence will be collected using non-verbal response cards to protect confidentiality and to assure respondents that enumerators will not know their responses.
Analyses will focus mainly on difference in estimates for the primary outcome measures of the self reported incidence by mothers and children (10-17) of acts of violence against women and children including child-witnessed violence in the past three months before the intervention and three months post intervention. Sub-group analysis by gender will be conducted. We will look at within group difference and between group differences. Retention will be assessed by comparing results from the pretest and post-test given on the first and last day of the intervention.
Secondary analyses on secondary outcomes such as parental attitudes toward violence and abuse and changes in intimate partner violence. We will examine the hypothesized theoretical links (e.g., mediation) between observed outcomes and program characteristics. A two-sample t-test will be used to look for differences in incidence of violence between the intervention and control groups. Multiple regression will be used to identify and examine predictor variables.
All data will be collected using electronic pads that contain self-checking logic within the questionnaire. Should missing data exceed 10%; multiple imputation procedures will be employed. However, our experience in similar studies is that imputation was not required because our fielding processes led to very high completions in the field.
Study instruments will include before focus group discussions (FGD) prior to the intervention, baseline, before and after workshop tests, three-month follow-up interviews, and post analysis FGD. Where possible, questions from other family and child violence studies will be utilized to allow for inter-study comparisons, especially focusing on evaluation studies of other The Faith House education programs and on the Violence Against Children in Tanzania National Survey conducted in 2009. All differences will be reported at a p <0.05. Data analysis will be completed using Stata v12. Importantly, we will also conduct a qualitative comparison of our outcome measures with published surveillance estimates in order to learn more about our source population and the potential impact of our program on the area if scaled up. As mentioned above, we will conduct interview and focus groups to improve program development, assess the fidelity of the implementation, and potential unintended consequences. Indeed, on-going study results will be monitored and a priori stopping rules assessed.
- Conditions
- Child Maltreatment
- Being tested
- TFH program
- Keywords
- Child violence, HIV AIDS conflicted couples, Intimate partner violence, Tanzania, Marriage counseling, Child maltreatment, Couples communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFH programBehavioural
Also called The Faithful House Training (TFH) Program
The Faithful House (TFH), is a three-day faith-based skills-building curriculum. The curriculum aims to increase household resilience by strengthening families and couples' relationships through enhanced couple communication
| Study group | Role | What they receive |
|---|---|---|
| Attend TFH Program | Experimental | Couples attend the three-day Faithful House Training program immediately Receives: Behavioral: TFH program |
| Wait-listed for TFH Program | No intervention | Couples attend The Faithful House program three-months after the initial group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of violence against or witnessed by children insults, and threats of physical harm and abandonment in the past three months and similar violent acts between partners that are observed by their children ages 10-17.
Change in self-reported incidence by parents and children (10-17) of acts of physical and emotional violence against children such as kicking, hitting, verbal insults, and threats of physical harm and abandonment and similar violent acts between partners that are observed by their children ages 10-17 years at baseline and three-months after couples attend seminar.
Measured: Baseline and three months after couples attend seminar
Secondary outcomes (1)
Attitudes about violence
The study will measure changes in men, women's and children (age 10-17) attitudes related to the use of emotional and physical violence using self-reported ratings of agreement using agreement (yes/no) or (strongly disagree, disagree, neither agree nor disagree, agree and strongly agree) on statements about the acceptability of violence in different situations such as infidelity, burning food, disobedience. Respondents survey at baseline and three months after seminar.
Measured: Baseline and three months after seminar
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Savannas Forever Tanzania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Arusha Lutheran Medical Centre
- Responsible party
- Sponsor
- Investigators
- Susan M James, MBA, Principal investigator, Savannas Forever TanzaniaSarah Milder, MPH, Principal investigator, Arundel Street ConsultingBernard J Ngowi, MD PhD, Principal investigator, National Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168985
- Sponsor's protocol ID
- SFTZ-C&VECF
- Acronym
- TFHEVAL
- Status last verified
- Jul 2014
- First submitted
- 18 Jun 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation for the Faithful House Program in Reducing Violence in Families in Which Couples Are Discordant or HIV/AIDS Positive in Arusha Region, in Tanzania
- ClinicalTrials.gov ID
- NCT02168985
- Acronym / sponsor ID
- TFHEVAL / SFTZ-C&VECF
- Conditions
- Child Maltreatment
- Keywords
- Child violence, HIV AIDS conflicted couples, Intimate partner violence, Tanzania, Marriage counseling, Child maltreatment, Couples communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Savannas Forever TanzaniaUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania, Arusha Lutheran Medical Centre
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Faithful House (TFH), is a 3-day faith-based skills-building curriculum which aims to increase household resilience by strengthening families. TFH draws on improved communication and conflict resolution skill building and the individual's faith-values as a catalyst for transformation in attitudes regarding gender roles in care giving and the use of violence in the home. The study hypothesis is that couples who complete the Faithful House Programme will demonstrate increased communication skills with their spouses and children, which reduces the negative impact of family stress triggers and ultimately leads to a reduction of intimate partner violence witnessed by children as well as physical and emotional violence against children by parents.
The mixed methods study will include a Randomized Control Trial (RCT) of HIV/AIDS infected or conflicted couples and a child in each household, focus group discussions (FGD) of men, women and children and key informant interviews of local experts in family violence and social protection service network providers.
Detailed description
A mixed-method evaluation of The Faithful House is proposed. In the main, we will conduct a randomized control trial of the education program to determine treatment effect. We will also conduct semi-structured interviews and focus groups with stakeholders. This more qualitative work will be done in order to refine our program and evaluation and to assess the fidelity of the intervention and assess and unintended consequences. Informed consent will be sought from all prospective participants.
The source population is families that receive HIV care from Arusha Lutheran Medical Centre and Selian Hospital. Participation and related compliance is enhanced because subjects come to the hospital for HIV treatment. Couples with children ages 10 to 17 years will be recruited to participate in a Faithful House workshop and study by hospital volunteers. All patients attending the clinic during the recruiting period will be screened based on eligibility criteria. The list of patients screened will be checked against the clinic register to verify that all potential participants were screened and all eligible respondents were invited to participate in the workshop and study.
The list of recruited couples will be randomized to receive the intervention or to serve as the control arm. The control arm will be offered the intervention at the conclusion of the study. The goal is to have N=150 couples in the treatment arm and N=150 couples in the control arm. The rationale for the sample size is twofold. First, given the estimated variances from surveillance studies the sample size permits the estimates of small to moderate effect sizes at 80% power and 5% Type I error. In simple terms, the proposed evaluation is strongly powered to detect politically and clinically meaningful effects. Second, given time, budget, and patient flow characteristics, 300 couples is near the maximum of our capacity. Baseline measures will be taken via survey on all participants in a clinical setting about one month prior to beginning the education program. Post program measures will be taken in a clinical setting three months after the intervention is complete. A context-based pretest and post-test will be administered to only those in the treatment group on the first and last day of the intervention.
Gender and age specific surveys will be used to interview men, women and children and questions on self-reported violence will be included in women and children's questionnaires. Answers to questions on violence will be collected using non-verbal response cards to protect confidentiality and to assure respondents that enumerators will not know their responses.
Analyses will focus mainly on difference in estimates for the primary outcome measures of the self reported incidence by mothers and children (10-17) of acts of violence against women and children including child-witnessed violence in the past three months before the intervention and three months post intervention. Sub-group analysis by gender will be conducted. We will look at within group difference and between group differences. Retention will be assessed by comparing results from the pretest and post-test given on the first and last day of the intervention.
Secondary analyses on secondary outcomes such as parental attitudes toward violence and abuse and changes in intimate partner violence. We will examine the hypothesized theoretical links (e.g., mediation) between observed outcomes and program characteristics. A two-sample t-test will be used to look for differences in incidence of violence between the intervention and control groups. Multiple regression will be used to identify and examine predictor variables.
All data will be collected using electronic pads that contain self-checking logic within the questionnaire. Should missing data exceed 10%; multiple imputation procedures will be employed. However, our experience in similar studies is that imputation was not required because our fielding processes led to very high completions in the field.
Study instruments will include before focus group discussions (FGD) prior to the intervention, baseline, before and after workshop tests, three-month follow-up interviews, and post analysis FGD. Where possible, questions from other family and child violence studies will be utilized to allow for inter-study comparisons, especially focusing on evaluation studies of other The Faith House education programs and on the Violence Against Children in Tanzania National Survey conducted in 2009. All differences will be reported at a p <0.05. Data analysis will be completed using Stata v12. Importantly, we will also conduct a qualitative comparison of our outcome measures with published surveillance estimates in order to learn more about our source population and the potential impact of our program on the area if scaled up. As mentioned above, we will conduct interview and focus groups to improve program development, assess the fidelity of the implementation, and potential unintended consequences. Indeed, on-going study results will be monitored and a priori stopping rules assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attend TFH Program | Experimental | Behavioral: TFH programCouples attend the three-day Faithful House Training program immediately |
| Wait-listed for TFH Program | No intervention | –Couples attend The Faithful House program three-months after the initial group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Both male and female partners in an HIV AIDS conflicted couple
- Has at least one child age 10 to 17 years living in couple's household
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TFH programAlso: The Faithful House Training (TFH) ProgramThe Faithful House (TFH), is a three-day faith-based skills-building curriculum. The curriculum aims to increase household resilience by strengthening families and couples' relationships through enhanced couple communication | Behavioural | Attend TFH Program |
Primary outcome
Incidence of violence against or witnessed by children insults, and threats of physical harm and abandonment in the past three months and similar violent acts between partners that are observed by their children ages 10-17.
Time frame: Baseline and three months after couples attend seminar
Change in self-reported incidence by parents and children (10-17) of acts of physical and emotional violence against children such as kicking, hitting, verbal insults, and threats of physical harm and abandonment and similar violent acts between partners that are observed by their children ages 10-17 years at baseline and three-months after couples attend seminar.
1 secondary outcome
Attitudes about violence
Time frame: Baseline and three months after seminar
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Savannas Forever Tanzania is a research organization in TanzaniaLink provided by the sponsor.
- National Institute for Medical ResearchLink provided by the sponsor.
- Selian Hospital and Selian Aids Control ProgrammeLink provided by the sponsor.
Related trials for Child Maltreatment
Enrolling by invitation
MIO-CPP to Improve the Well-being, Permanency, and Safety Outcomes for Young Children at Risk of or in Out-of-home Placement in Philadelphia and Bucks Counties, and Affected by Maternal Substance Use
Substance Use Disorders, Parent-Child Relations
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruiting
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Safety, Psychological, Acceptability of Health Care
Recruiting
Rigorous Evaluation of the READY to Stand Curriculum to Prevent the Commercial Sexual Exploitation of Children
Sex Trafficking, Sex Crimes
Enrolling by invitation
Prevalence of Childhood Maltreatment Among Women With Dysmenorrhea.
Dysmenorrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan M James, MBA principal investigator
Savannas Forever Tanzania
Sarah Milder, MPH principal investigator
Arundel Street Consulting
Bernard J Ngowi, MD PhD principal investigator
National Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TFH program in people with Child Maltreatment, run by Savannas Forever Tanzania at 1 site in Tanzania.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jul 2014. 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 Tanzania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorothy Brewster Lee, MD (+255 764501245, dkm4dbl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of violence against or witnessed by children insults, and threats of physical harm and abandonment in the past three months and similar violent acts between partners that are observed by their children ages 10-17. (time frame: Baseline and three months after couples attend seminar). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2014.