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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05632237
Other study ID # cafo
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 16, 2022
Est. completion date March 1, 2023

Study information

Verified date January 2023
Source Boston College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 226
Est. completion date March 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Sierra Leone the Child Reintegration Centre Bo

Sponsors (4)

Lead Sponsor Collaborator
Boston College Child Reintegration Centre, Christian Alliance for Orphans, Helping Children Worldwide

Country where clinical trial is conducted

Sierra Leone, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Change in child- and caregiver-reported parenting behaviors by caregiver 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
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