NCT03594617

Brief Summary

Sub-Saharan Africa, with more than 56 million orphans worldwide, is the most affected region in terms of orphans to be cared for (UNICEF, 2014). The recently developed preventative approach Interaction Competencies with Children - for Caregivers (ICC-C; Hecker, Mkinga, Ssenyonga, \& Hermenau, 2017) trains the essential interaction skills in working with children. The focus here is on strengthening a warm, sensitive and reliable relationship between caregiver and child as well as on non-violent education strategies. In a first pilot study the feasibility of the approach icould be demonstrated (Hermenau, Kaltenbach, Mkinga, \& Hecker, 2015). The study applies a two-arm cluster-randomized controlled design. The participating institutions will be randomly divided into intervention and control bodies. The follow-up examination should take place three months after the intervention. All caregivers in facility (N = approx. 150) and 25 randomly selected children (age: 6-12) per facility (N = 200) will be included in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
374

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

August 14, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 8, 2020

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

July 11, 2018

Last Update Submit

May 7, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in caregivers' application of harsh discipline

    The Conflict Tactics Scale Parent-Child version (CTSPC) will assess caregiver's use of violent discipline measure against children in the child care institution. All items are rated on a 7-point Likert scale from never (0) to more than 20 times (25). The focus will be particularly on the subscales physical violence (13 items, potential range: 0 to 325 with higher scores indicating more violence) and emotional violence (5 items, potential range: 0-125, with higher scores indicating more violence).

    The CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)

  • Change in children's exposure to harsh discipline by caregivers

    The Conflict Tactics Scale Parent-Child version (CTSPC) will assess the children's self-reported experiences of violent discipline in the child care institution. The focus will be particularly on the subscales physical violence (13 items, potential range: 0 to 325 with higher scores indicating more violence) and emotional violence (5 items, potential range: 0-125, with higher scores indicating more violence).

    CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)

Secondary Outcomes (2)

  • Change in student's mental health

    SDQ will be used at (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)

  • Change in caregiver's attitudes towards harsh discipline

    The adapted version of CTSPC will be used at T 1 (baseline, prior to intervention) and T2 (follow-up, 3-6 months after intervention)

Study Arms (2)

ICC-C

EXPERIMENTAL

Intervention: Interaction Competencies with children - for Caregivers (ICC-C) 11 days with 8 hours of training for caregivers. Core training components include caregiver-child interactions, maltreatment prevention, effective discipline strategies, child-centered institutional care, identifying and supporting burdened children and implementation of the training materials into the daily working

Behavioral: Interaction Competencies with Children - for Caregiver

Control institutions

NO INTERVENTION

The control institutions do not receive any intervention.

Interventions

Interaction Competencies with Children - for Caregiver (ICC-C) aims to reduce maltreatment and to improve care quality in institutional care facilities. Following the idea of a train-the-trainer approach, ICC-C is designed to be delivered by trained local facilitators. ICC-C is based on attachment, behavioral and social learning theories. The key principles are its feasibility in low-resource contexts, participatory approach, and practical orientation. ICC-C includes sessions on (a) caregiver-child interaction, (b) maltreatment prevention, (c) effective non-violent caregiving strategies, and (d) identifying and supporting burdened children.

ICC-C

Eligibility Criteria

Age6 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Legal age
  • Written informed consent
  • Between 6 and 12 years
  • Written informed consent by head of institutional care facility \& children oral assent

You may not qualify if:

  • Acute drug or alcohol intoxication
  • Known psychiatric disorder
  • \- Known psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dar es Salaam University College of Education

Dar es Salaam, Tanzania

Location

Related Publications (2)

  • Hecker T, Mkinga G, Hartmann E, Nkuba M, Hermenau K. Sustainability of effects and secondary long-term outcomes: One-year follow-up of a cluster-randomized controlled trial to prevent maltreatment in institutional care. PLOS Glob Public Health. 2022 May 20;2(5):e0000286. doi: 10.1371/journal.pgph.0000286. eCollection 2022.

  • Hecker T, Mkinga G, Kirika A, Nkuba M, Preston J, Hermenau K. Preventing maltreatment in institutional care: A cluster-randomized controlled trial in East Africa. Prev Med Rep. 2021 Oct 9;24:101593. doi: 10.1016/j.pmedr.2021.101593. eCollection 2021 Dec.

MeSH Terms

Interventions

Caregivers

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Tobias Hecker, PhD

    Bielefeld University

    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
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Clinical Psychology and Behvavioral Neuroscience

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 20, 2018

Study Start

August 14, 2018

Primary Completion

July 1, 2019

Study Completion

April 30, 2020

Last Updated

May 8, 2020

Record last verified: 2019-09

Locations