MedPath

Reintegration of Children From Institutions in Azerbaijan

Not Applicable
Active, not recruiting
Conditions
Child Mental Disorder
Emotional Trauma
Child Maltreatment
Interventions
Behavioral: Usual Care
Behavioral: Family Strengthening
Behavioral: Mental Health Screening, Referral and Connection to Services
Other: Economic Empowerment
Registration Number
NCT05396625
Lead Sponsor
University of Chicago
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).

Detailed Description

The countries of the former Soviet Union (fSU) and Eastern Europe have the highest number of children in institutional care worldwide--up to 1.3 million children. Institutional care is associated with severe developmental setbacks and poor mental health outcomes for children, and many fSU countries are looking to develop reintegration programs supported by evidence.

Acknowledging the detrimental effects of institutionalization on children, the government of Azerbaijan jointly with UNICEF is implementing a national de-institutionalization program (De-I) aiming to close down orphanages and place children in family-oriented care. The De-I program provides basic case management services to reunite children with their families of origin, but does not address mental health needs of institutionalized children, who after years of isolation, maltreatment and traumatic experiences in orphanages, are returning home to parents who are unprepared to deal with the emotional and behavioral problems of their children. In addition, the current De-I model does not address the family-level poverty which led to institutionalization in the first place, creating a risk for future abandonment and poor psychosocial outcomes.

This study focuses on building research capacity in the field of global mental health to identify effective prevention strategies and develop innovative psychosocial intervention models tailored to the local context of post-Soviet countries. According to the National Institute of Mental Health Grand Challenges in Global Mental Health, advancement of prevention and implementation of early interventions (Goal B) is among the key global mental health priorities. Early prevention reduces the risk of developing mental disorders in adulthood, has long-term impact and may concurrently affect a number of psychosocial outcomes. There are no evidence-based, culturally-tailored, preventive mental health interventions available for institutionalized children in Azerbaijan and other fSU countries. Existing interventions in the U.S. often require highly skilled clinicians and are not adapted for the context of developing countries with limited financial and human mental health resources.

Effective parenting and behavior management skills are essential for preventing emotional and behavioral problems among children. However, in low-resource settings, non-parenting factors such as poverty induced parental stress have also been linked to poor child mental health outcomes and cannot be addressed by parenting skills programs alone. Based on the formative research conducted by the investigative team (2014-2018) in collaboration with a local Community Collaborative Board (CCB), we selected and adapted empirically-tested intervention components to ensure their cultural relevance, viability and inexpensive delivery, essential for developing countries. To promote family stability and improve the emotional well-being among children reuniting with psychosocial functioning of institutionalized children, the proposed intervention will include three components: a) a family-strengthening program, b) referral and access to mental health treatment; and c) economic empowerment. The proposed study will test these intervention components with 400 child-parent dyads in a trial using the Multiphase Optimization Strategy (MOST) to compare different intervention components and identify the most optimal combination. If efficacious, the optimized intervention may enhance the traditional De-I model and be scaled up throughout Azerbaijan and other fSU countries.

The specific aims of the research study within the R01 mechanism are:

Aim 1: To refine, test and compare the effects of three intervention components (family strengthening intervention; referral and access to mental health treatment; and economic empowerment) on mental health outcomes (a) post-traumatic symptoms; b) disturbances of attachment; c) internalizing problems--depression, anxiety; and d) externalizing problems--aggressive or disruptive behavior) among 7-12 year old children from orphanages re-entering family contexts in Azerbaijan.

Aim 2: To examine the role of hypothesized intervention mediators (emotion regulation, supportive parenting, and parental stress) and moderators (child's age, gender, length in institution, family structure, and intervention adherence) in improvements in child mental health outcomes.

Aim 3: To explore facilitating factors and barriers to implementation and participation in each intervention component (at individual, family, and organizational levels) using qualitative interviews with intervention participants and service providers. We will also conduct a secondary analysis to estimate the preliminary costs (operations and personnel) of each intervention component compared to the usual care alone.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
400
Inclusion Criteria
  1. The child is between ages 7 and 12;
  2. The caregiver is at least 18 years old;
  3. The child has a history of institutionalization (lived in an orphanage or another institution in Azerbaijan for a minimum of one month);
  4. The child has been reunited with a caregiver (biological parent or kin relative) within a year prior to the study;
  5. The child has a caregiver who is a biological parent or kin relative (e.g., grandparent) who serves as the primary caregiver;
  6. The child and caregiver can commit to study participation.
Exclusion Criteria
  1. Child is not between the ages of 7-12.
  2. Caregiver is below the age of 18.
  3. Eligible child and/or caregiver cannot commit to study participation.
  4. 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Family Strengthening, Mental Health, Economic EmpowermentMental Health Screening, Referral and Connection to ServicesGroup will receive: 1) Usual Care, 2) Family Strengthening, 3) Mental Health Screening \& Referral, and 4) Economic Empowerment Interventions
Family Strengthening, Mental Health, Economic EmpowermentUsual CareGroup will receive: 1) Usual Care, 2) Family Strengthening, 3) Mental Health Screening \& Referral, and 4) Economic Empowerment Interventions
Family Strengthening, Economic EmpowermentEconomic EmpowermentGroup will receive: 1) Usual Care, 2) Family Strengthening, and 3) Economic Empowerment Interventions
Family Strengthening, Mental Health, Economic EmpowermentFamily StrengtheningGroup will receive: 1) Usual Care, 2) Family Strengthening, 3) Mental Health Screening \& Referral, and 4) Economic Empowerment Interventions
Family Strengthening, Mental Health, Economic EmpowermentEconomic EmpowermentGroup will receive: 1) Usual Care, 2) Family Strengthening, 3) Mental Health Screening \& Referral, and 4) Economic Empowerment Interventions
Family Strengthening, Mental HealthMental Health Screening, Referral and Connection to ServicesGroup will receive: 1) Usual Care, 2) Family Strengthening, and 3) Mental Health Screening \& Referral Interventions
Family Strengthening OnlyUsual CareGroup will receive: 1) Usual Care and 2) Family Strengthening Interventions
Family Strengthening, Mental HealthUsual CareGroup will receive: 1) Usual Care, 2) Family Strengthening, and 3) Mental Health Screening \& Referral Interventions
Family Strengthening, Economic EmpowermentUsual CareGroup will receive: 1) Usual Care, 2) Family Strengthening, and 3) Economic Empowerment Interventions
Mental Health, Economic EmpowermentUsual CareGroup will receive: 1) Usual Care, 2) Mental Health Screening \& Referral, and 3) Economic Empowerment Interventions
Mental Health, Economic EmpowermentEconomic EmpowermentGroup will receive: 1) Usual Care, 2) Mental Health Screening \& Referral, and 3) Economic Empowerment Interventions
Economic Empowerment OnlyUsual CareGroup will receive: 1) Usual Care and 2) Economic Empowerment Interventions
Family Strengthening, Mental HealthFamily StrengtheningGroup will receive: 1) Usual Care, 2) Family Strengthening, and 3) Mental Health Screening \& Referral Interventions
Family Strengthening, Economic EmpowermentFamily StrengtheningGroup will receive: 1) Usual Care, 2) Family Strengthening, and 3) Economic Empowerment Interventions
Family Strengthening OnlyFamily StrengtheningGroup will receive: 1) Usual Care and 2) Family Strengthening Interventions
Mental Health, Economic EmpowermentMental Health Screening, Referral and Connection to ServicesGroup will receive: 1) Usual Care, 2) Mental Health Screening \& Referral, and 3) Economic Empowerment Interventions
Mental Health OnlyUsual CareGroup will receive: 1) Usual Care and 2) Mental Health Screening \& Referral Interventions
Mental Health OnlyMental Health Screening, Referral and Connection to ServicesGroup will receive: 1) Usual Care and 2) Mental Health Screening \& Referral Interventions
Usual Care OnlyUsual CareGroup will receive: Usual Care Intervention only
Economic Empowerment OnlyEconomic EmpowermentGroup will receive: 1) Usual Care and 2) Economic Empowerment Interventions
Primary Outcome Measures
NameTimeMethod
Change in child mental health measured using the Strengths and Difficulties Questionnaire (SDQ)Baseline, 12 months, 24 months

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.

Changes in child self-reported symptoms of depression using the Center for Epidemiological Studies Depression Scale for Children (CES-DC)Baseline, 12 months, 24 months

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.

Changes in child's post-traumatic symptoms using the Revised Child Impact of Events ScaleBaseline, 12 months, 24 months

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.

Secondary Outcome Measures
NameTimeMethod
Changes in savingsBaseline, 12 months, 24 months

Monthly savings in the Child Savings Accounts are collected through participant's bank statements. Higher average monthly saving amount would indicate improvement.

Change in supportive parentingBaseline, 12 months, 24 months

The use of harsh parenting practices and level of parental support using Parenting Styles \& Dimensions Questionnaire - Short version (PSDQ-Short Version). The scale includes 32 items and can be grouped into three styles and seven dimensions of parenting (e.g., physical coercion, verbal hostility, and punishment; support and affection, regulation, and autonomy). The score in all dimensions and styles ranges from 1 to 5, with higher scores indicating more use of its dimensions or styles.

Change in parental stressBaseline, 12 months, 24 months

The parental level of distress is measured using the Depression Anxiety Stress Scale - 21 items / DASS-21). The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. The scores for each of three sub-scales range from 0 to 42. Lower DASS score would indicate a reduction in the level of stress and anxiety among parents.

Trial Locations

Locations (2)

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

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Baku, Azerbaijan

Research and Education Center

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Baku, Azerbaijan

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