Parent-Child RelationsNCT05632237
Evaluation of a Family Strengthening Program Evaluation in Sierra Leone to Prevent Family Separation
A study testing Family strengthening program in people with Parent-Child Relations and Emotion Regulation, run by Boston College at 1 site in Sierra Leone.
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. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, Emotion Regulation, Economic Problems
- What is being tested?
- Family strengthening program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteSierra Leone
- Study dates
- 16 Oct 2022to 22 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Family strengthening program
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family strengthening programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Family strengthening program | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver and child change in emotional regulation as measured by the Difficulties in Emotional Regulation (DERS) scale
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
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
Measured: Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start16 Oct 2022
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- Christian Alliance for Orphans, Helping Children Worldwide, Child Reintegration Centre
- Responsible party
- Principal investigator, Sarah Neville, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632237
- Sponsor's protocol ID
- cafo
- Status last verified
- Aug 2024
- First submitted
- 9 Nov 2022
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Family Strengthening Program Evaluation in Sierra Leone to Prevent Family Separation
- ClinicalTrials.gov ID
- NCT05632237
- Acronym / sponsor ID
- cafo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- Christian Alliance for Orphans, Helping Children Worldwide, Child Reintegration Centre
- Study start
- 16 Oct 2022 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family strengthening programPhase 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. | Behavioural | Family strengthening program |
Primary outcome
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
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
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family strengthening program in people with Parent-Child Relations and Emotion Regulation, run by Boston College at 1 site in Sierra Leone.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.