Clinical trial NCT02633319: Malezi Na Kilimo Bora - Skilful Parenting and Agribusiness Child Abuse Prevention Study
Official title: Malezi ne Kilimo Bora (Good Parenting and Farming) - Skilful Parenting and Agribusiness Child Abuse Prevention Study (SPACAPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Abuse
Parenting
Keywords: Parenting
Child maltreatment
Economic strengthening
Early childhood development
Cluster randomized controlled trial
Pilot evaluation
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Tanzanian National Institute of Medical Research
name: University of Glasgow
name: Investing in Children and Our Societies
name: UBS Optimus Fund
First posted: 2015-12-17
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion criteria for villages (n = 8):

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

Inclusion criteria for participating farmer groups (n = 16, 2 per village):

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

Inclusion criteria for adults caregivers (n = 240, 30 per village):

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

Exclusion criteria for adult participants:

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.

Inclusion criteria for child respondents (n = 240, 30 per village):

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

Exclusion criteria for child respondents:

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.

Inclusion criteria for observed children (n = 240, 30 per village):

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

Inclusion criteria for adult ICS programme facilitators:

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

Primary outcomes:
measure: Change in Child Abuse - Parent Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Child Abuse - Child Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Parenting Behaviour - Adult Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Parenting Behaviour - Child Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
Secondary outcomes:
measure: Change in Parental Attitudes to Punishment
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Parenting Stress - Adult Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Caregiver Depression - Adult Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change Child Behaviour - Adult Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change Child Behaviour - Child Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Intimate partner Violence - Adult Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Child Labor - Adult Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Household Hunger - Adult Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Agricultural Assets - Adult Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Household Assets - Adult Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Early Childhood Home Environment - Observed and Adult Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Child Development - Adult Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Infant/Toddler Weight
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Infant/Toddler Height
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Household Hunger - Child Report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Child food consumption - Child report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Child labour - Child report
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Child Attitudes to Punishment
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Child Depression
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Child Sexual Behavior
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Child Alcohol Use
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Change in Adult Alcohol Use
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
Other outcomes:
measure: Basic Caregiver and Child Demographic Information
timeFrame: Baseline
measure: Change in Caregiver General Health
timeFrame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up
measure: Caregiver/Child Disability
timeFrame: Baseline
measure: Parental History of Child Maltreatment
timeFrame: Baseline
measure: Obstacles to Engagement Scale
timeFrame: Baseline
Locations:
city: Mwanza
country: Tanzania
facility: Tanzania National Institute of Medical Research
Study officials:
affiliation: University of Oxford
name: Frances Gardner, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanzania National Institute of Medical Research
name: Joyce Wamoyi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.