Malezi Na Kilimo Bora - Skilful Parenting and Agribusiness Child Abuse Prevention Study

NCT ID: NCT02633319

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2017-03-01

Brief Summary

The Malezi ne Kilimo Bora ("Good Parenting and Farming" in Kiswahili) Skilful Parenting and Agribusiness Child Abuse Prevention Study is a collaboration between the University of Oxford, University of Glasgow, and the Tanzania National Medical Research Institute (NIMR). It is pilot cluster randomised controlled trial (cRCT) of a community-based intervention implemented by Investing in Children and Our Societies (ICS), an international non-governmental organization (NGO) with extensive experience operating in rural Tanzania. The overall focus of the project is to evaluate ICS's agribusiness and skilful parenting programmes' impact on the prevention of child maltreatment and improvement of child and family psychosocial and economic wellbeing (n = 8 villages, n = 16 farmer groups, n = 240 families).

Detailed Description

Background on Child Maltreatment in Tanzania

Child maltreatment and other childhood adversities often occur in many low- and middle-income countries at rates that are higher than in high-income countries - rates that often exceed 50%. In Tanzania, a national survey examining violence against children (VAC) found that almost 73.5% of females and 71.7% of males between the ages of 13 and 24 had experienced physical violence by prior to the age of 18. Furthermore, 23.6% of females and 27.5% of males had experienced emotional violence by an adult during childhood, and 27.9% of females and 13.4% of males had experienced some form of sexual violence before the age of 18 years. In addition, the survey identified an overlap among physical, emotional, and sexual violence against children. Approximately 80% of respondents who experienced sexual violence also experienced physical violence as a child, and nearly all children who experienced physical violence also experienced emotional violence. The VAC study also found that parents and other adult relatives are the most commonly reported perpetrators of physical and emotional violence against children, with corporal punishment considered a social norm.

Recent advances in neuroscience, genomics, developmental psychology, epidemiology, and economics have shed light on the long-term and far-reaching consequences of childhood adversities, many of which, like child maltreatment, are directly related to poor parenting. These consequences include serious physical and mental health problems later in life, as well as difficulties in school, jobs, and relationships. Child maltreatment can have substantial intergenerational effects in which some parents who experienced maltreatment during childhood are more vulnerable to the risk of maltreating their own children. Child maltreatment is also a risk factor for later intimate partner violence, increased risk of HIV-infection, and transactional sex amongst AIDS-affected youth. Furthermore, not only is child maltreatment a serious public health and human rights issue, but it comes at an economic cost due to expenses relating to the treatment of victims' health problems, criminal justice and welfare costs, and lower economic productivity.

The risks factors of child maltreatment can be best understood using an ecological framework. A recent review of 23 quantitative studies in Africa by Meinck et al identified a number of child, family, and social risk factors for child maltreatment. Child factors associated with increased likelihood of physical abuse included younger children, boys, children with disability or chronic illness, child behaviour problems, and school non-attendance and poor performance. Family-level factors include caregiver chronic illness, HIV/AIDS, caregiver mental health problems, caregiver disability, domestic violence, substance abuse, poor family functioning, and inconsistent parenting. Finally, household poverty and low socioeconomic status was found to be a major factor for increased risk of child abuse, as well as indirectly through increased family stress and reduced parental involvement.

Parenting Programmes to Prevent Child Maltreatment

Parenting programmes have shown particular promise in preventing child maltreatment and other childhood adversities and averting many of the life-long negative consequences for children and society. A recent meta-analysis reported that parenting programs successfully reduced substantiated and self-reported child maltreatment reports and reduced the potential for child maltreatment, both in high and middle-income countries. Often group-based, these programmes typically aim to strengthen caregiver-child relationships through play and praise, and to help parents to manage children's behaviour through effective, age-appropriate, positive discipline strategies. However, almost all the evidence for their effectiveness comes from high-income countries and they often cost many thousands of dollars per family served. They are thus prohibitively expensive for most governments and NGOs in low- and middle-income countries. Furthermore, their license-holders have been reluctant to implement them in such settings due to what they perceive as lack of the requisite infrastructure and trained personnel. In sum, there are currently no parenting programmes that are both evidence-based and affordable for low- and middle-income countries (LMIC), where the need is the greatest.

Economic Strengthening Programmes

Household poverty has also been identified as a risk factor for parental psychological distress and depression as well as physical and emotional child abuse. Consequently, in addition to improving parenting behaviour, in order to reduce the risk of child maltreatment, it may be necessary to address issues of poverty through economic strengthening programmes. These programmes include micro-financing, conditional and unconditional cash transfers, and agricultural interventions that provide skills training, credit loans, access to markets. However, there is still little empirical evidence on the benefits of an integrated approach of economic strengthening and parenting interventions. It may be sufficient to provide parent management training alone as a key mechanism of change in improving parent-child relationships and reducing the risk of child maltreatment. For instance, a recent meta-analysis by Leijten et al found that parenting programs were equally effective for socioeconomically disadvantaged families in comparison to non-disadvantaged families. On the other hand, some evidence suggests that families require additional support that addresses other social risk factors including poverty and material hardship. Furthermore, economic strengthening programs may in fact harm children if not combined with adequate child protection. Other research in East Africa indicates linkages between economic strengthening programs and child wellbeing, as well as the importance of integrating such interventions with psychosocial support. Nevertheless, more research is needed to understand the role of economic strengthening programs and parent management training in reducing on the risk of child maltreatment, as well as the utility of using a combined approach.

Study Aims and Design

This study aims to contribute to the literature on the prevention and reduction of child maltreatment in northern Tanzania. It will evaluate ICS's community-based intervention model that combines Agribusiness and Skilful Parenting training using a pilot cluster randomized controlled trial design (cRCT) in order to test intervention feasibility, acceptability, and preliminary efficacy. It will enable us to conduct both a process and rigorous outcome evaluation using a mixed-methods approach with qualitative focus groups and in-depth interviews combined with quantitative implementation data and self-report questionnaires.

This pilot cRCT will randomly allocate 8 villages (16 farmer groups, 2 farmer groups per village, 240 families, 20 families per farmer group) into the following four allocation groups (2 villages per allocation group):

1. Agribusiness only

2. Skilful Parenting only

3. Agribusiness plus Skilful Parenting

4. One-year wait-list control

For villages allocated to Agribusiness only, Skilful Parenting only, and/or the wait-list control group, participating farmer groups and families will have the opportunity to participate in the other intervention components after the final follow-up data assessment (1-year after baseline) provided that analysis of the results do not indicate any harmful effects.

This study will examine preliminary intervention effects comparing intervention arms with the wait-list control group as well as among active arms (Proschan, 1999). Although our focus will be on the effect of economic strengthening combined with parenting programs on reducing the risk of child maltreatment and improve child wellbeing, the investigators will also be examining the potential benefits of Skilful Parenting or Agribusiness programs delivered separately in comparison to controls.

This study will qualitatively and quantitatively examine intervention effects on parent-child interaction and child behaviour across the developmental spectrum. This includes (1) parents' report on interactions with a selected child between the ages of 3 to 17, (2) child report on parent-child interaction, child mental health, and child behaviour for families with children aged 10 to 16, and (3) early childhood development assessments in families with children aged 0 to 3. The investigators will also examine the feasibility (acceptability, implementation, and participation) of the Agribusiness and Skilful Parenting interventions.

Quantitative data collection will occur at 3 stages: baseline, immediate post-test, and 1-year follow-up from baseline. The investigators will use descriptive and psychometric scales to measure family socioeconomic status, parent-child interaction (including child maltreatment or harsh parenting), parent mental health, child depression and behaviour, early child development and stimulation, and child biometric data. Quantitative data collection will include parent report assessments for families with children aged 3 to 17, child report assessments for families with children aged 10 to 16, and early childhood development assessments for families with children aged 0 to 3. As a result, each participating family will have a maximum of 3 assessments per data collection stage.

Qualitative data will be collected from multiple sources using focus groups and in-depth interviews to strengthen the reliability of results: participating parents and co-parents, children, and facilitators. Focus groups (n=4) with participating families in the intervention arms will occur in local community centers at immediate post-test. In-depth interviews will take place at participants' homes with a targeted selection of participating parents, co-parents, and children (aged 10-16) at immediate post-test. In addition, focus groups will be conducted with program facilitators (n=8) at immediate post-test. Additional data will be collected from participants who drop out of the programme or have low attendance rates to examine barriers to participation.

Quantitative process data will be collected using trained staff responsible for monitoring programme facilitators. Weekly facilitator fidelity checklists will be administered after each session of Skillful Parenting. Research staff will also collect data on participant enrolment, participation, and engagement using attendance registers and client satisfaction surveys administered the end of program completion. This will allow us to quantitatively examine predictors of programme enrolment, participation, and dropout as well as potential risk factors for withdrawal from the intervention.

Conditions

Child Abuse; Parenting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Parenting Training

Skilful Parenting: 12-week group-based parent intervention delivered by Investing in Children and Our Societies to caregivers who are members of farmer groups in participating villages.

Group Type: EXPERIMENTAL

Skilful Parenting

Intervention Type: BEHAVIORAL

Skilful Parenting is a 2-week group-based parenting intervention delivered by Investing in Children and Our Societies to caregivers who are members of farmer groups in participating villages. It reinforces positive parenting practices, empowering parents to address the challenges that they face in bringing up their children. The intervention helps create parent peer groups to share ideas, support, information, and resources in the community. The intervention involves weekly sessions with farmer groups, awareness raising amongst local authorities and communities, and the establishment of parent peer groups. Topics consist of the following issues related to parenting: roles and responsibilities; family relations; communication; values; positive discipline; child protection; and family budgeting.

Agricultural Training

Agrics: Initial 3-month agricultural training intervention with ongoing support afterwards.

Group Type: EXPERIMENTAL

Agrics

Intervention Type: OTHER

Agrics provides smallholder farmers, organized in farmer groups, with access to farm inputs on a credit basis, and agricultural extension and advisory services to improve farming techniques and improve market connections. These services include an intensive intervention during planting season and then ongoing support after the initial 3-month intervention.

Parenting and Agricultural Training

Village farmer groups receiving both Skilful Parenting and Agrics interventions.

Group Type: EXPERIMENTAL

Skilful Parenting

Intervention Type: BEHAVIORAL

Skilful Parenting is a 2-week group-based parenting intervention delivered by Investing in Children and Our Societies to caregivers who are members of farmer groups in participating villages. It reinforces positive parenting practices, empowering parents to address the challenges that they face in bringing up their children. The intervention helps create parent peer groups to share ideas, support, information, and resources in the community. The intervention involves weekly sessions with farmer groups, awareness raising amongst local authorities and communities, and the establishment of parent peer groups. Topics consist of the following issues related to parenting: roles and responsibilities; family relations; communication; values; positive discipline; child protection; and family budgeting.

Agrics

Intervention Type: OTHER

Agrics provides smallholder farmers, organized in farmer groups, with access to farm inputs on a credit basis, and agricultural extension and advisory services to improve farming techniques and improve market connections. These services include an intensive intervention during planting season and then ongoing support after the initial 3-month intervention.

Control

6-month wait-list control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Skilful Parenting

Skilful Parenting is a 2-week group-based parenting intervention delivered by Investing in Children and Our Societies to caregivers who are members of farmer groups in participating villages. It reinforces positive parenting practices, empowering parents to address the challenges that they face in bringing up their children. The intervention helps create parent peer groups to share ideas, support, information, and resources in the community. The intervention involves weekly sessions with farmer groups, awareness raising amongst local authorities and communities, and the establishment of parent peer groups. Topics consist of the following issues related to parenting: roles and responsibilities; family relations; communication; values; positive discipline; child protection; and family budgeting.

Intervention Type: BEHAVIORAL

Agrics

Agrics provides smallholder farmers, organized in farmer groups, with access to farm inputs on a credit basis, and agricultural extension and advisory services to improve farming techniques and improve market connections. These services include an intensive intervention during planting season and then ongoing support after the initial 3-month intervention.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Situated within 1 hour driving distance from Shinyanga, Tanzania

2. Provide community consent via community local leader and approval from local authorities

3. Contain registered farmer groups

1. Situated within participating village

2. Registered with Tanzanian Ministry of Agriculture within the previous 3 years

3. Registered to participate in ICS's Agribusiness and Skilful Parenting programme

4. Provide consent via farmer group leader

1. Age 18 or older

2. Serves as the primary caregiver of a child in the household between the ages of 3 and 17

3. Lives in the house at least 4 nights per week.

4. Is a registered member of the included agricultural farmer group

5. Provides consent to participate in the full study

1. Age 10 to 17 years at initial assessment

2. Lives in the house at least 4 nights per week

3. Must have an adult primary caregiver who lives in the household, who provides consent, and who participates in the study

4. Provides assent to participate in the full study

1. Age 0 to 3 years at initial assessment

2. Lives in the house at least 4 nights per week

3. Must have an adult primary caregiver who lives in the household, who provides consent, and who participates in the study

1. Age 18 or older

2. Is registered as a facilitator of ICS's Agribusiness or Skilful Parenting programme

3. Provides consent to participate in the full study

Exclusion Criteria

1. Any adult exhibiting severe mental health problems or acute mental disabilities.

2. Any adult that has been referred to social services or child protection services during the course of baseline data collection as a result of reported or observed indications of significant potential psychological harm towards a child.

1. Any child who is either experiencing severe mental health problems, has acute developmental disabilities,

2. If the child participant has been referred to social services during baseline data collection due to reported or observed indications of significant harm.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanzanian National Institute of Medical Research

UNKNOWN

Sponsor Role: collaborator

University of Glasgow

OTHER

Sponsor Role: collaborator

Investing in Children and Our Societies

UNKNOWN

Sponsor Role: collaborator

UBS Optimus Fund

UNKNOWN

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frances Gardner, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Joyce Wamoyi, PhD

Role: PRINCIPAL_INVESTIGATOR

Tanzania National Institute of Medical Research

Locations

Tanzania National Institute of Medical Research

Mwanza, , Tanzania

Countries

Tanzania

References

Lachman J, Wamoyi J, Spreckelsen T, Wight D, Maganga J, Gardner F. Combining parenting and economic strengthening programmes to reduce violence against children: a cluster randomised controlled trial with predominantly male caregivers in rural Tanzania. BMJ Glob Health. 2020 Jul;5(7):e002349. doi: 10.1136/bmjgh-2020-002349.

Reference Type: DERIVED

PMID: 32641291 (View on PubMed)

Other Identifiers

SSD/CUREC1A/14-SSH_C2_15_023

Identifier Type: -

Identifier Source: org_study_id