NCT02633319

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

November 2, 2015

Last Update Submit

June 21, 2017

Conditions

Keywords

ParentingChild maltreatmentEconomic strengtheningEarly childhood developmentCluster randomized controlled trialPilot evaluation

Outcome Measures

Primary Outcomes (4)

  • 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 (α = 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

  • 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 (α = 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

  • 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 α = 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

  • 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 α = 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 Outcomes (22)

  • Change in Parental Attitudes to Punishment

    Baseline; 6-Months Follow-Up; 12-Months Follow-Up

  • Change in Parenting Stress - Adult Report

    Baseline; 6-Months Follow-Up; 12-Months Follow-Up

  • Change in Caregiver Depression - Adult Report

    Baseline; 6-Months Follow-Up; 12-Months Follow-Up

  • Change Child Behaviour - Adult Report

    Baseline; 6-Months Follow-Up; 12-Months Follow-Up

  • Change Child Behaviour - Child Report

    Baseline; 6-Months Follow-Up; 12-Months Follow-Up

  • +17 more secondary outcomes

Other Outcomes (5)

  • Basic Caregiver and Child Demographic Information

    Baseline

  • Change in Caregiver General Health

    Baseline; 6-Months Follow-Up; 12-Months Follow-Up

  • Caregiver/Child Disability

    Baseline

  • +2 more other outcomes

Study Arms (4)

Parenting Training

EXPERIMENTAL

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.

Behavioral: Skilful Parenting

Agricultural Training

EXPERIMENTAL

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

Other: Agrics

Parenting and Agricultural Training

EXPERIMENTAL

Village farmer groups receiving both Skilful Parenting and Agrics interventions.

Behavioral: Skilful ParentingOther: Agrics

Control

NO INTERVENTION

6-month wait-list control group

Interventions

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.

Parenting TrainingParenting and Agricultural Training
AgricsOTHER

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.

Agricultural TrainingParenting and Agricultural Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Situated within 1 hour driving distance from Shinyanga, Tanzania
  • Provide community consent via community local leader and approval from local authorities
  • Contain registered farmer groups
  • Situated within participating village
  • Registered with Tanzanian Ministry of Agriculture within the previous 3 years
  • Registered to participate in ICS's Agribusiness and Skilful Parenting programme
  • Provide consent via farmer group leader
  • Age 18 or older
  • Serves as the primary caregiver of a child in the household between the ages of 3 and 17
  • Lives in the house at least 4 nights per week.
  • Is a registered member of the included agricultural farmer group
  • Provides consent to participate in the full study

You may not qualify if:

  • Any adult exhibiting severe mental health problems or acute mental disabilities.
  • 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.
  • Age 10 to 17 years at initial assessment
  • Lives in the house at least 4 nights per week
  • Must have an adult primary caregiver who lives in the household, who provides consent, and who participates in the study
  • Provides assent to participate in the full study
  • Any child who is either experiencing severe mental health problems, has acute developmental disabilities,
  • If the child participant has been referred to social services during baseline data collection due to reported or observed indications of significant harm.
  • Age 0 to 3 years at initial assessment
  • Lives in the house at least 4 nights per week
  • Must have an adult primary caregiver who lives in the household, who provides consent, and who participates in the study
  • Age 18 or older
  • Is registered as a facilitator of ICS's Agribusiness or Skilful Parenting programme
  • Provides consent to participate in the full study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanzania National Institute of Medical Research

Mwanza, Tanzania

Location

Related Publications (1)

  • 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.

Study Officials

  • Frances Gardner, DPhil

    University of Oxford

    PRINCIPAL INVESTIGATOR
  • Joyce Wamoyi, PhD

    Tanzania National Institute of Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2015

First Posted

December 17, 2015

Study Start

August 1, 2015

Primary Completion

December 31, 2016

Study Completion

March 1, 2017

Last Updated

June 22, 2017

Record last verified: 2017-06

Locations