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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02633319
Date of registration: 02/11/2015
Prospective Registration: No
Primary sponsor: University of Oxford
Public title: Malezi Na Kilimo Bora - Skilful Parenting and Agribusiness Child Abuse Prevention Study SPACAPS
Scientific title: Malezi ne Kilimo Bora (Good Parenting and Farming) - Skilful Parenting and Agribusiness Child Abuse Prevention Study (SPACAPS)
Date of first enrolment: August 1, 2015
Target sample size: 248
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02633319
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Tanzania
Contacts
Name:     Frances Gardner, DPhil
Address: 
Telephone:
Email:
Affiliation:  University of Oxford
Name:     Joyce Wamoyi, PhD
Address: 
Telephone:
Email:
Affiliation:  Tanzania National Institute of Medical Research
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Parenting
Child Abuse
Intervention(s)
Other: Agrics
Behavioral: Skilful Parenting
Primary Outcome(s)
Change in Child Abuse - Child Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Child Abuse - Parent Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Parenting Behaviour - Adult Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Parenting Behaviour - Child Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Secondary Outcome(s)
Change Child Behaviour - Adult Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Child Attitudes to Punishment [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Household Hunger - Child Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change Child Behaviour - Child Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Adult Alcohol Use [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Agricultural Assets - Adult Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Household Assets - Adult Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Child Alcohol Use [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Child labour - Child report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Child Development - Adult Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Child food consumption - Child report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Child Sexual Behavior [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Household Hunger - Adult Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Caregiver Depression - Adult Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Child Labor - Adult Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Intimate partner Violence - Adult Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Child Depression [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Early Childhood Home Environment - Observed and Adult Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Infant/Toddler Weight [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Parental Attitudes to Punishment [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Parenting Stress - Adult Report [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Change in Infant/Toddler Height [Time Frame: Baseline; 6-Months Follow-Up; 12-Months Follow-Up]
Secondary ID(s)
SSD/CUREC1A/14-SSH_C2_15_023
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Glasgow
UBS Optimus Fund
Investing in Children and Our Societies
Tanzanian National Institute of Medical Research
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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