Impact Evaluation Study of The Faithful House Programme on Violence Reduction in Families

Child Maltreatment Clinical Trial

— TFHEVAL  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02168985
• Other study ID #: SFTZ-C&VECF
• Status: Not yet recruiting
• Phase: N/A
• First received: June 18, 2014
• Last updated: July 5, 2014
• Start date: July 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2014
• Source: Savannas Forever Tanzania
• Contact: Dorothy Brewster Lee, MD
• Phone: +255 764501245
• Email: dkm4dbl[@]gmail.com
• Is FDA regulated: No
• Health authority: Tanzania: National Institute for Medical Research
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: February 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Child Maltreatment

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Tanzania	Arusha Lutheran Medical Centre	Arusha	Arusha Region

Sponsors (3)

Lead Sponsor	Collaborator
Savannas Forever Tanzania	Arusha Lutheran Medical Centre, National Institute for Medical Research, Tanzania

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and three months after couples attend seminar	No
Secondary	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.	Baseline and three months after seminar	No

External Links

•   National Institute for Medical Research
•   Savannas Forever Tanzania is a research organization in Tanzania
•   Selian Hospital and Selian Aids Control Programme