- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05632237
Evaluation of a Family Strengthening Program Evaluation in Sierra Leone to Prevent Family Separation
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bo, Sierra Leone
- the Child Reintegration Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- 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.
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: 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
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- cafo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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