Reintegration of Children From Institutions in Azerbaijan

NCT05396625 | Active Not Recruiting DMC

• 2 other identifiers: IRB20-1018R01HD099847
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

To prevent mental health problems among 7-12 children from orphanages reunited with their biological or extended families in Azerbaijan, this study will refine and test three evidence-based intervention approaches (a) family strengthening intervention; b) mental health screening and referral for treatment; and c) economic empowerment in the form of Child Development Accounts. The study will use a randomized experimental design and participating families will be assigned to receive the family strengthening, mental health, or economic interventions. Eligible and consenting 400 child-caregivers dyads will complete baseline, 1-year, and 2-year follow-up measures. Additionally, post-intervention qualitative interviews (n=60) will solicit narrative information about participants' and services providers' reactions and experiences with each intervention component and will provide more comprehensive evidence about the interventions' efficacy. It is hypothesized that by enhancing children's coping skills, strengthening child-parent relationships, and reducing parental stress, an intervention can help children demonstrate fewer symptoms of: a) disturbances of attachment; b) internalizing problems (depressive or anxious mood), c) externalizing problems (aggressive, delinquent, or disruptive behaviors); d) post-traumatic stress; and e) lower prevalence of diagnoses (e.g. depression, anxiety, PTSD, oppositional-defiant disorder, and reactive attachment disorder).

Conditions

Emotional Trauma; Child Mental Disorder; Child Maltreatment

Keywords

Azerbaijan; Children; Child Mental Health; Family Strengthening; Economic Empowerment; Child and Family Well-being; Child Separation; Child Maltreatment

Outcome Measures

Primary Outcomes (3)

• Change in child mental health measured using the Strengths and Difficulties Questionnaire (SDQ)

  Questions assess child's internalizing problems (depression, anxiety) and externalizing problems (aggressive or disruptive behavior). SDQ includes five scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behaviors reported by parent/caregiver and teacher. With the exception of prosocial behaviors, lower score indicates reduction in mental health symptoms.

  Baseline, 12 months, 24 months

• Changes in child self-reported symptoms of depression using the Center for Epidemiological Studies Depression Scale for Children (CES-DC)

  The Center for Epidemiological Studies Depression Scale for Children (CES-DC) is a 20 item self-report questionnaire for young people between the ages of 6 and 17. Possible scores ranging from 0 to 60 and lower score indicates a reduction in depressive symptoms.

  Baseline, 12 months, 24 months

• Changes in child's post-traumatic symptoms using the Revised Child Impact of Events Scale

  Revised Child Impact of Events Scale (CRIES-8) is a 8-item child-friendly measure designed to screen children at risk for Post-Traumatic Stress Disorder (PTSD). the CRIES-8 has two sub-scales (Intrusion and Avoidance). Total scores range from 0 to 40, with higher scores indicated higher PTSD symptoms. A reduction in trauma symptoms would indicate improvement.

  Baseline, 12 months, 24 months

Secondary Outcomes (3)

• Change in supportive parenting

  Baseline, 12 months, 24 months

• Change in parental stress

  Baseline, 12 months, 24 months

• Changes in savings

  Baseline, 12 months, 24 months

Study Arms (8)

Family Strengthening, Mental Health, Economic Empowerment

EXPERIMENTAL

Group will receive: 1) Usual Care, 2) Family Strengthening, 3) Mental Health Screening \& Referral, and 4) Economic Empowerment Interventions

Behavioral: Usual Care; Behavioral: Family Strengthening; Behavioral: Mental Health Screening, Referral and Connection to Services; Other: Economic Empowerment

Family Strengthening, Mental Health

EXPERIMENTAL

Group will receive: 1) Usual Care, 2) Family Strengthening, and 3) Mental Health Screening \& Referral Interventions

Behavioral: Usual Care; Behavioral: Family Strengthening; Behavioral: Mental Health Screening, Referral and Connection to Services

Family Strengthening, Economic Empowerment

EXPERIMENTAL

Group will receive: 1) Usual Care, 2) Family Strengthening, and 3) Economic Empowerment Interventions

Behavioral: Usual Care; Behavioral: Family Strengthening; Other: Economic Empowerment

Family Strengthening Only

EXPERIMENTAL

Group will receive: 1) Usual Care and 2) Family Strengthening Interventions

Behavioral: Usual Care; Behavioral: Family Strengthening

Mental Health, Economic Empowerment

EXPERIMENTAL

Group will receive: 1) Usual Care, 2) Mental Health Screening \& Referral, and 3) Economic Empowerment Interventions

Behavioral: Usual Care; Behavioral: Mental Health Screening, Referral and Connection to Services; Other: Economic Empowerment

Mental Health Only

EXPERIMENTAL

Group will receive: 1) Usual Care and 2) Mental Health Screening \& Referral Interventions

Behavioral: Usual Care; Behavioral: Mental Health Screening, Referral and Connection to Services

Economic Empowerment Only

EXPERIMENTAL

Group will receive: 1) Usual Care and 2) Economic Empowerment Interventions

Behavioral: Usual Care; Other: Economic Empowerment

Usual Care Only

EXPERIMENTAL

Group will receive: Usual Care Intervention only

Behavioral: Usual Care

Interventions

Usual Care BEHAVIORAL

All participants will receive the following services: case management and psychosocial support (e.g., assessment and identification of families eligible for reunification; preparing children and parents for reunification; and assistance with receiving social benefits such as Targeted Social Assistance, alimonies, or disability benefits); referrals to schools outside of their orphanage; and leisure activities for children (e.g., music, sport, and drama) provided by the orphanage staff and municipal social services.

Economic Empowerment Only; Family Strengthening Only; Family Strengthening, Economic Empowerment; Family Strengthening, Mental Health; Family Strengthening, Mental Health, Economic Empowerment; Mental Health Only; Mental Health, Economic Empowerment; Usual Care Only

Family Strengthening BEHAVIORAL

Due to its focus on family-strengthening, the study uses the evidence-based intervention, SAFE Children, which employs a multiple family group format and is designed to improve family functioning, strengthen child-parent relationships and communication, enhance supportive parenting strategies, and prevent emotional and behavioral problems among at-risk children. The family-focused intervention consists of weekly multiple family group meetings (e.g. about 5 families per group). All interested family members are invited to join the sessions. The adapted intervention incorporates new sessions that address unique issues faced by families reuniting with formerly institutionalized children, such as, separation and attachment issues, children's feelings of resentment, parents' feelings of guilt and shame, stigmatized status in the community. Each session lasts about one to one and a half hours and delivered by facilitator and co-facilitator at the SOS Child and Family Center.

Also known as: Schools and Families Educating Children

Family Strengthening Only; Family Strengthening, Economic Empowerment; Family Strengthening, Mental Health; Family Strengthening, Mental Health, Economic Empowerment

Mental Health Screening, Referral and Connection to Services BEHAVIORAL

Children assigned to this intervention will receive clinical assessment performed by psychiatrists at the National Mental Health Centre in Azerbaijan. From there, each child will have an individual plan developed by the multidisciplinary team and will be connected to the National Mental Health Centre clinicians to receive corresponding mental health services.

Family Strengthening, Mental Health; Family Strengthening, Mental Health, Economic Empowerment; Mental Health Only; Mental Health, Economic Empowerment

Economic Empowerment OTHER

The economic component will be in the form of Child Development Accounts/CDAs, an asset-based strategy encouraging savings and investment. This component will connect families to a bank and train them on how to save small amounts, which will be matched by contributions from the project. Matched savings will be deposited in a separate account and can be used only towards a child's education or for housing. The project will provide $50 as seed money to open a savings account in the child's name. The child's family members will make small monthly contributions to the CDA, and savings of up to $20 per month will be matched with project funds at a rate of 2:1. Caregivers will also receive training on savings and financial planning. The curriculum will be taught by trainers from the SOS in a group format for 5 sessions and will cover these topics: The Importance of Saving; Identifying and Managing Resources; Setting Up a Savings System; Sources of Income; and Budgeting and Spending.

Economic Empowerment Only; Family Strengthening, Economic Empowerment; Family Strengthening, Mental Health, Economic Empowerment; Mental Health, Economic Empowerment

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child is between ages 7 and 12;
• The caregiver is at least 18 years old;
• The child has a history of institutionalization (lived in an orphanage or another institution in Azerbaijan for a minimum of one month);
• The child has been reunited with a caregiver (biological parent or kin relative) within a year prior to the study;
• The child has a caregiver who is a biological parent or kin relative (e.g., grandparent) who serves as the primary caregiver;
• The child and caregiver can commit to study participation.

You may not qualify if:

• Child is not between the ages of 7-12.
• Caregiver is below the age of 18.
• Eligible child and/or caregiver cannot commit to study participation.
• Children or caregivers with significant cognitive, behavioral, and/ or mental health impairment (e.g., severe developmental disorder, psychosis, severe symptoms of trauma) that may interfere with their ability to consent to and/or benefit from the program or to participate safely will also be excluded from the study.

Sponsors & Collaborators

• University of Chicago: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Mental Health Centre: collaborator
• SOS Children's Villages: collaborator
• Research and Education Center: collaborator

Study Sites (2)

National Mental Health Centre under the Ministry of Health, Republic of Azerbaijan

Baku, Azerbaijan

Location

Research and Education Center

Baku, Azerbaijan

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

Schools; Referral and Consultation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Leyla Ismayilova, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The eligible and consenting child-caregiver dyads will be randomized into one of eight experimental conditions. The randomization will be performed by the Project Director immediately following the baseline visit. A secure, web-based, password-protected database built on a REDCap (Research Electronic Data Capture) platform will be used to randomize participants into the 8 experimental conditions and to manage recruitment; eligibility assessment; scheduling and tracking of baseline and follow-up assessments; and sending intervention reminders. All data collectors (or interviewers) will receive a highly structured and intensive interview training conducted by the PIs. Data collectors and outcome assessors will be masked to participants' intervention group assignment.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will use a randomized design and apply MOST approach to test and compare the three intervention components: a) a family-strengthening intervention; b) mental health screening and referral for treatment; and c) economic empowerment in the form of Child Savings Accounts. There are three factors (intervention components) and each factor has two levels. This is a 2\*2\*2, or 2 by 3, factorial design and, therefore, the study will have eight different experimental conditions or groups (2 by 3=8). The eligible and consenting child-parent dyads (N=400) will be randomly assigned to one of eight study groups (50 dyads per group), determining how many and which intervention components participants will receive. Given this design, half of the sample (n=200) will receive each intervention component (e.g., families assigned to Groups 1-4 will receive the family strengthening intervention and will be compared to families from Groups 5-8). All participants will receive Usual Care.

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 31, 2022
• Study Start: May 1, 2021
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Once all of the data have been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. Upon completion of the deliverable(s), the requestor will be instructed to destroy all copies of the data. If deliverables have not been produced yet, the agreement to share data will be revisited annually to decide to continue sharing or terminate the sharing agreement. If the Investigators determine that the sharing agreement should be terminated, the requestor will be instructed to destroy all copies of the data.
• Access Criteria: The University of Chicago has a data sharing agreement that specifies the following conditions be met before data are shared: 1. A formal research question is specified a priori; 2. Names, affiliations, and roles of any other individuals who will access the shared data; 3. The deliverable(s)-e.g., manuscript, conference presentation-are specified a priori; 4. Proper credit and attribution-e.g., authorship, co-authorship, and order-for each deliverable are specified a priori; 5. A statement indicating an understanding that the data can not be further shared with any additional individual(s) or parties without the PI's permission; 6. Institutional Review Board approval for use of the data (or documentation that Institutional Review Board has determined the research is exempt);

Locations

AZ (2)