Evaluation of a Family Strengthening Program Evaluation in Sierra Leone to Prevent Family Separation

April 16, 2025 updated by: Sarah Neville, Boston College
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sierra Leone
      • Bo, Sierra Leone
        • the Child Reintegration Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  1. 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)
  2. Primary child is ages 9-13
  3. Dyad is actively participating in Child Reintegration Centre services (i.e., child must have been seen by the case manager in the last month)
  4. Dyad lives in the Bo area.

Exclusion criterion:

(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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Family strengthening program
Behavioral: Family strengthening program

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.
No Intervention: Care as usual
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Caregiver and child change in emotional regulation as measured by the Difficulties in Emotional Regulation (DERS) scale
Time Frame: Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention
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)
Time Frame: Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention
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
Time Frame: Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention
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
Time Frame: Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in child- and caregiver-reported parenting behaviors by caregiver
Time Frame: Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention
Measures developed for this study tailored for context and intervention content; e.g., asking child about their life, spending one-on-one time with child, physically showing affection, giving compliments/praise, using a routine, apologizing, providing emotional support
Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Christian Alliance for Orphans
Helping Children Worldwide
Child Reintegration Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • cafo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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