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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Dorothy Brewster Lee, MD contact

+255 764501245

dkm4dbl@gmail.com

Susan M James, MBA contact

+255 783514380

susan.james@sftz.org

Tanzania1 site
  • Arusha Lutheran Medical Centre

    Arusha, Arusha

    John A Laiser, + 255 754761295, johnlaiser@yahoo.com

Other trials in Tanzania

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.

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 groups in NCT02168985
Study groupRoleWhat they receive
Attend TFH ProgramExperimentalCouples attend the three-day Faithful House Training program immediately
Receives: Behavioral: TFH program
Wait-listed for TFH ProgramNo interventionCouples 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.

  1. 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)
  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.

  1. First posted20 Jun 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionOct 2014 (estimated)
  4. Study completionFeb 2015 (estimated)

Resources

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)
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

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.

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