NCT05632237

Brief Summary

In Sierra Leone, poverty and challenges with family functioning can lead to family separation, and children may go to live on the street or enter residential care institutions/orphanages. Helping Children Worldwide (HCW), a non-profit organization with over 20 years of experience in Sierra Leone, has developed a two-part Family Strengthening Program delivered by their program partners in Sierra Leone, the Child Reintegration Centre, to improve families financial literacy and attachment between caregivers and children, with the ultimate goal of preventing family separation. The hypothesis of this study is that the Family Strengthening Program program is effective at (1) changing parenting behaviors, (2) improving emotional regulation, (3) improving caregiver-child attachment, and (4) improving financial literacy in dyads consisting of children ages 9-13 and their caregivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

October 16, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2023

Completed
Last Updated

April 20, 2025

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

November 9, 2022

Last Update Submit

April 16, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Caregiver and child change in emotional regulation as measured by the Difficulties in Emotional Regulation (DERS) scale

    Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention

  • Change in child attachment as measured by the Inventory of Parent and Peer Attachment (IPPA)

    Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention

  • Change in caregiver- and child-reported use of punishment by caregiver

    Measures developed for this study tailored for context; e.g., flogging child with hand or cane, public shaming, withholding food

    Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention

  • Change in self-reported economic well-being

    Measures developed for this study tailored for context and intervention content; e.g., awareness of income/spending, saving and budgeting behaviors, ability to pay for unexpected expense

    Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention

Secondary Outcomes (1)

  • Change in child- and caregiver-reported parenting behaviors by caregiver

    Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention

Study Arms (2)

Family strengthening program

EXPERIMENTAL
Behavioral: Family strengthening program

Care as usual

NO INTERVENTION

These participants have already been receiving case management from the Child Reintegration Centre prior to the study, and they will continue to receive care as usual, which is to receive normal case management visits without this added Family Strengthening Program component. Case management consists of a social work staff alternating between visiting children at home or at school each month to provide supervision, coaching, counseling, assessments, and identification of additional support needs.

Interventions

Phase I: 2-day Family Strengthening Workshop. The specific topics included in the workshop include: emotions, Body Progressive Muscle Relaxation, body stretch, self care, apologizing, routines to promote attachment, teamwork, saving, delayed gratification, anticipating unexpected expenses, identifying family strengths and values. Phase II: Case management with family strengthening curriculum. Curriculum is delivered over the course of four visits (about 3 months), some of which involve both caregiver and child while others are just for the caregiver. Topics included are using appropriate discipline, effective communication for family problem-solving, and home budgeting.

Family strengthening program

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Dyads must consist of a principal child (the one whose situation initiated their involvement with the Child Reintegration Centre) and their primary caregiver (as defined by the Child Reintegration Centre as the person in the family primarily responsible for the health and wellbeing of the principal child and is noted as such in their case file)
  • Primary child is ages 9-13
  • Dyad is actively participating in Child Reintegration Centre services (i.e., child must have been seen by the case manager in the last month)
  • Dyad lives in the Bo area.
  • (1) Family has been assessed by the Child Reintegration Centre to be in active crisis, i.e., specific concerns about the child being at-risk or unsafe (suspicions of abuse or neglect).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Child Reintegration Centre

Bo, Sierra Leone

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
During baseline data collection, participants were not yet assigned to arms, so all parties were masked.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 30, 2022

Study Start

October 16, 2022

Primary Completion

May 22, 2023

Study Completion

May 22, 2023

Last Updated

April 20, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations