Parenting Clinical Trial
— SPACAPSOfficial title:
Malezi ne Kilimo Bora (Good Parenting and Farming) - Skilful Parenting and Agribusiness Child Abuse Prevention Study (SPACAPS)
Verified date | June 2017 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 248 |
Est. completion date | March 1, 2017 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Tanzania | Tanzania National Institute of Medical Research | Mwanza |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Investing in Children and Our Societies, Tanzanian National Institute of Medical Research, UBS Optimus Fund, University of Glasgow |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Basic Caregiver and Child Demographic Information | Basic caregiver and child demographic information will be asked using items from the UNICEF Multiple Indicators Cluster Survey (MICS) Household Survey. It assesses caregiver/child age, gender, marital status, employment status, education level, basic literacy, child's relationship to caregiver, presence of child's biological parents (including reasons for absence), and other household members' age, gender and relationship to caregiver. It also assesses other household socio-demographic characteristics including household structure, family employment, and whether or not the family receives any governmental grant support. | Baseline | |
Other | Change in Caregiver General Health | Caregiver general health will be assessed using 3 items from the Medical Outcomes Study (MOS) Short Form-12 Health Survey (SF-12). This scale is an adapted version of the MOS SF-34 Health Survey to examine physical and mental health. Items include difficulty in moderate daily activities, such as moving boxes, shopping, or carrying a child. Response options are based on a 3-point Likert-like scale (1 = yes, limited a lot; 3 = no, not limited at all). An additional item requires respondents to assess their overall health on a 5-point Likert scale (1 = excellent; 5 = poor). | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Other | Caregiver/Child Disability | Caregiver and child disability will be assessed using the census questions (4 items) on disability endorsed by the Washington Group. These questions rely on self-report of difficulty the caregiver or child may experience in seeing, hearing, walking or climbing steps, remembering, washing him/herself, and communicating in his/her usual language. Response options have been simplified to "yes" or "no" for each item. Two additional items asks respondents whether they or their child has a disability. If they respond "yes", they are asked to specify which type of disability. | Baseline | |
Other | Parental History of Child Maltreatment | Parental history of child maltreatment in their families of origin will be measured using an adapted version of the ISPCAN Child Abuse Screening Tools Retrospective version (ICAST-R, 10 items). This scale utilises parent self-report of experiences during their own childhood (under 18 years old) to assesses the history of incidence of physical maltreatment, verbal abuse, and sexual abuse. In this study, incidence of past history of child maltreatment will be scored as dichotomous variables for physical, verbal, and sexual abuse, as well as an overall indication of previous child abuse (0 = no abuse; 1 = previous abuse). | Baseline | |
Other | Obstacles to Engagement Scale | Adult report of barriers to program participation and engagement will be measured using the Obstacles to Engagement Scale. This 14-itme scale has four subscales: family obstacles (4 items); relevance of parenting programmes (4 items); suitability of group-based programmes (4 items); and barriers due to time commitments (2 items). Participants rate each item on a 7-point sliding Likert scale ranging from "Strongly disagree" to "Strongly agree." Scores for each subscale are created as well as an overall barrier to engagement score by summing totals. | Baseline | |
Primary | Change in Child Abuse - Parent Report | Child abuse will be measured using adapted versions of the ISPCAN Child Abuse Screening Tool-Parent version (ICAST-P), a multi-national and consensus-based survey instrument measuring the incidence and prevalence of child abuse and neglect. This 19-item scale ICAST-P was validated in 6 LMIC and 7 languages (a = 0.77-0.88) and measures four types of abuse: physical, emotional and sexual abuse, as well as neglect. In this study, the response code was adapted to a frequency scale from 0 to more than 8 times as certain behaviour occurred in the past month. In this study, incidence child maltreatment will be scored as dichotomous variables for physical, verbal, and sexual abuse, as well as an overall indication of previous child abuse (0 = no abuse; 1 = previous abuse). The investigators will also assess frequency of overall abuse by summing all of the subscales as well as for each individual subscale. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Primary | Change in Child Abuse - Child Report | Child report of child abuse will be measured using adapted versions of the ISPCAN Child Abuse Screening Tool-Child version (ICAST-C), a multi-national and consensus-based survey instrument measuring the incidence and prevalence of child abuse and neglect. This 32-item scale ICAST-C was validated in 6 LMIC and 7 languages (a = 0.77-0.88) and measures four types of abuse: physical, emotional and sexual abuse, as well as neglect. In this study, the response code was adapted to a frequency scale from 0 to more than 8 times as certain behaviour occurred in the past month. In this study, incidence child maltreatment will be scored as dichotomous variables for physical, verbal, and sexual abuse, as well as an overall indication of previous child abuse (0 = no abuse; 1 = previous abuse). The investigators will also assess frequency of overall abuse by summing all of the subscales as well as for each individual subscale. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Primary | Change in Parenting Behaviour - Adult Report | Parent-child interaction, will be measured using the Alabama Parenting Questionnaire (APQ) - Adult Report (37 items). The APQ contains five subscales assessing Positive Parenting (8 items), Parent Involvement (8 items), Inconsistent Discipline (11 items), Poor Supervision (10 items). The APQ has been shown to have moderate to strong internal reliability for both parent and child reports (Cronbach's a = 0.50 to 0.89). It has been used widely including in LMIC such as South Africa and Mexico. Caregivers report on the frequency of parenting behaviour based on a 4-point Likert scale (0 = never; 3 = Often, more than 5 times). Items are summed to create total frequency score (range 0 to 81) as well as for each subscale. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Primary | Change in Parenting Behaviour - Child Report | Parent-child interaction, will be measured using the Alabama Parenting Questionnaire - Child Report (42 items). The APQ contains five subscales assessing Positive Parenting (8 items), Parent Involvement (8 items), Inconsistent Discipline (11 items), Poor Supervision (10 items), and Harsh Discipline (5 items). The APQ has been shown to have moderate to strong internal reliability for both parent and child reports (Cronbach's a = 0.50 to 0.89). It has been used widely including in LMIC such as South Africa and Mexico. Children report on the frequency of parenting behaviour based on a 4-point Likert scale (0 = never; 3 = Often, more than 5 times). Items are summed to create total frequency score (range 0 to 126) as well as for each subscale. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Parental Attitudes to Punishment | This study asked one question from the UNICEF Multiple Indicator Cluster Survey regarding parental attitudes to physical discipline based on a 5-point Likert scale of 0 to 4: "In order to bring up, raise up, or educate a child properly, the child needs to be physically punished." Caregivers report whether they disagree or agree with the statement (0 = disagree strongly; 4 = agree strongly). | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Parenting Stress - Adult Report | Parenting stress will be assessed using the Parental Stress Scale (PSS; 18 items). PSS has been widely used to measure parenting stress, including in LMIC, such as Pakistan and China. The scale has also been used with non-parent caregivers such as grandparents. Caregivers report current positive attitudes (n = 8, e.g., "I feel close to my child") and negative attitudes (n = 10, e.g., "I feel overwhelmed by the responsibility of being a parent") related to parenting stress based on a five-point Likert scale (0 = strongly disagree; 4 = strongly agree). Positive items are reversed and then all items are summed to create a total parenting stress score (range 0 to 90). | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Caregiver Depression - Adult Report | The Centre for Epidemiological Studies Depression Scale (CES-D) (20 items) has been widely used throughout LMIC to assess self-report screening of adult depression. This was used in previous studies in sub-Saharan Africa of caregivers with strong reliability (a = .91). Caregivers report on the frequency of depressive symptoms in the previous week (0 to 7 times, e.g., "I thought my life was a failure"). Items are summed to create an overall depression score. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change Child Behaviour - Adult Report | Strengths and Difficulties Questionnaire has been used previously in Tanzania and has officially been translated into Kiswahili. It examines prosocial behaviour, conduct problems, hyperactivity-inactivity, peer problems, and emotional problems. The investigators also added a 5-item subscale to assess local cultural norms of child behaviour regarding respectability, or Hashima (e.g., "My child's behaviour brings embarrassment to my family"). Items are summed for each subscale (range 0 to 10). Behaviour problem subscales are also summed to create a total child behaviour problems score (0 to 50). | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change Child Behaviour - Child Report | Strengths and Difficulties Questionnaire has been used previously in Tanzania and has officially been translated into Kiswahili. It examines prosocial behaviour, conduct problems, hyperactivity-inactivity, peer problems, and emotional problems. The investigators also added a 5-item subscale to assess local cultural norms of child behaviour regarding respectability, or Hashima (e.g., "My child's behaviour brings embarrassment to my family"). Items are summed for each subscale (range 0 to 10). Behaviour problem subscales are also summed to create a total child behaviour problems score (0 to 50). | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Intimate partner Violence - Adult Report | The Revised Conflict Tactics Scale Short Form (CTS2S; 10 items) measures exposure to intimate partner physical and psychological violence (IPV). Assessments use adult self-report on the frequency of negotiation, physical assault, psychological aggression, sexual coercion, and physical injury. Answers are coded on a 5-point Likert scale of 0 to 4 (0 = never happened; 4 = more than 3 times in the past month). The CTS2S will determine an overall indication of IPV on a level of severity (sum of items) and prevalence (dichotomous variable indicating experience of conflict or not) as well as for each subscale. The CTS2S has been used extensively in studies on IPV in sub-Saharan Africa. The original validation study showed strong internal consistency (a = .89). | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Child Labor - Adult Report | Adult report of child involvement in labour will be measured using items from the UNICEF MICS Household Survey. This 6-item questionnaire asks caregivers whether their child was involved in farm work, running or helping to run a business, production of goods for sales, collection of firewood, or other household activities. It also assesses the amount of hours per week that the child is involved in each household task. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Household Hunger - Adult Report | Relative poverty will be assessed using 3 items from the Hunger Scale Questionnaire. These items examine food shortage and hunger in the household. Parents respond positively or negatively regarding the occurrence of hunger during the past 30 days and whether it occurred more than 5 times (e.g., "the household has run out of money to by food"). The scale produces scores for single occurrence and intensity of hunger. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Agricultural Assets - Adult Report | In order to assess the impact of agribusiness training, household agricultural assets will be measured using 8 items from the UNICEF MICS Household Survey. Caregivers will be asked if the household owns land for farming and, if so, how many acres (individually, not collectively). They will also be asked which animals they own and how many (e.g., cattle). | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Household Assets - Adult Report | Household assets will be assessed using items from the Economic Asset Index (9-items). The Economic Asset Index (EAI) measures relative household poverty based on methodology used in the Demographic Health Survey (DHS). This measurement has been used in over 55 countries, including Tanzania, and by the World Bank to asses relative poverty from a variety of factors. Instead of directly measuring poverty by income, the EAI examines adult reports of household ownership of consumer goods (cell phone, radio, car, etc.) and access to utilities and running water. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Early Childhood Home Environment - Observed and Adult Report | Observed early childhood home environment will be assessed using the Home Observation for Measurement of the Environment (HOME) assessment tool for infants and toddlers aged 0 to 3 years (44 items). It combines interview and observational items to assess the quality of family environment and engagement in child rearing. The scale includes 6 subscales: responsiveness (11 items), acceptance (7 items), organisation (6 items), play/learning materials (9 items), involvement (6 items), and variety of experience (5 items). The investigators eliminated one item on whether the family has a pet since it was considered culturally irrelevant. Double negative items on the Acceptance subscale were reversed to simplify the constructs. Assessors record whether the parent either reports the behaviour occurring or the behaviour is observed during the interview (0 = no; 1 = yes). Items are summed on each subscale as well as for an overall score on home environment stimulation and responsiveness. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Child Development - Adult Report | Child development will be assessed using the parent-report version of the Ages and Stages Questionnaire Version 3 (ASQ-3). This screening tool measures infant and toddler development from 2 months to 60 months (5 years) of age according to the following developmental domains: communication, gross motor, fine motor, problem-solving, and personal social skills. Each domain has 6 items (30 items in total). Distinct questionnaires are administered according to the child's age in 2-month intervals rounded to the nearest interval. The ASQ-3 is administered via caregiver self-report based on "Yes," "Sometime," or "Not Yet" for each developmental milestone. In addition, if the caregiver is not sure of a specific item, they are given the opportunity to perform the task with their infant or toddler. The entire assessment takes approximately 20 minutes. Items for each subscale are summed to create total scores as well as an overall indication of child development. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Infant/Toddler Weight | Child weight will be determined using a 25 kg Salter hanging scale (Weighing equipment, High Holborn, London, United Kingdom) with the child in light clothes and no shoes. A standard beam balance (SECA) will be used in weighing the young infants. The readings will be recorded to the nearest 0.1kg. Calibration of weighing scale to zero will be performed every day during the assessment period. A known 1kg weight will be used to standardize the scales every day for accuracy and consistency. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Infant/Toddler Height | Child height will be measured using a length board. Children will be placed lying shoeless in the supine position on the board with their heads placed at 900 to the fixed head piece. Research assistants will straighten the legs of the child at the knees and ensured that feet were at right angle to the sliding foot piece, which will be brought into contact to the child's heels. Child length will be recorded to the nearest 0.1 centimeters. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Household Hunger - Child Report | Child report on relative poverty will be assessed using 3 items from the Hunger Scale Questionnaire. These items examine food shortage and hunger in the household. Children will be asked to respond positively or negatively regarding the occurrence of hunger during the past 30 days and whether it occurred more than 5 times (e.g., "the household has run out of money to by food"). The scale produces scores for single occurrence and intensity of hunger. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Child food consumption - Child report | This study will assess consumption via child report on average meals consumed per day in the past week based on items from the UNICEF MICS Household Survey (e.g., "how many meals did the participant consumer per day"). | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Child labour - Child report | Child involvement in labour will be measured using items from the UNICEF MICS Household Survey. This 6-item questionnaire asks children whether they were involved in household chores, farm work, running or helping to run a business, production of goods for sales, collection of firewood, or other household activities in the past week. It also assesses the amount of hours per week that the child is involved in each household task. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Child Attitudes to Punishment | This study asked one question from the UNICEF Multiple Indicator Cluster Survey regarding parental attitudes to physical discipline based on a 5-point Likert scale of 0 to 4: "In order to bring up, raise up, or educate a child properly, the child needs to be physically punished." Children report whether they disagree or agree with the statement (0 = disagree strongly; 4 = agree strongly). | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Child Depression | Child depressive symptoms will be measured using the 10-item Child Depression Inventory (CDI) short form. This was used previously with vulnerable children in sub-Saharan Africa including a recent cross-cultural adaptation in in Kiswahili in rural Tanzania. Each item is scored on a three-point scale (0 absent; 1 moderate; 2 severe) according to symptom severity with a total possible score ranging from 0 to 20. The Tanzanian study showed acceptable reliability (a = .66). | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Child Sexual Behavior | Sexual behaviour Child sexual behaviour will be measured using 15 items from the South African National Survey of HIV and risk behavior amongst young South Africans. This study will measure sexual debut, concurrent sexual partners, sexual activity under the influence of alcohol and under the influence of drugs, and pregnancy. These items have been used in previous studies on youth in sub-Saharan Africa. In the current study, the time period was adapted to the past month to be appropriate for the present RCT research project. | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Child Alcohol Use | Child use of alcohol will be assessed by measuring alcohol consumption during the past month (1 item). Due to the sensitive nature of these items, additional items dealing with other activities to reduce stress have been included in this section to encourage accuracy (2 items; e.g., "In the past month, did the particpant play sports or dance with friends to relax?"). | Baseline; 6-Months Follow-Up; 12-Months Follow-Up | |
Secondary | Change in Adult Alcohol Use | Parental dependency on alcohol will be assessed by measuring alcohol consumption during the past month (1 item). Dependency is based on 3 or more drinks per day for female participants and 5 or more per day for male participants. Due to the sensitive nature of these items, additional items dealing with other activities to reduce stress have been included in this section to encourage accuracy (3 items; e.g., "In the past month, has the participant been for a walk or done some other exercise to help the participant relax?"). | Baseline; 6-Months Follow-Up; 12-Months Follow-Up |
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