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).

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.

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.

Datasets will be made available to any individual who makes a direct request to the PIs and indicates the data will be used for the purposes of research (per Code of Federal Regulation Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.").

Shared data will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects. Data will be shared in electronic format native to the software used by the Investigators; requestors are expected to handle converting electronic formats (though the Investigators will consider converting to tab-delimited text format if possible).

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.

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);

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.