Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05396625
Status:
UNKNOWN
Last Update Posted:
2022-05-31
First Post:
2022-05-19
Brief Title:
Reintegration of Children From Institutions in Azerbaijan
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Optimizing Prevention Approaches for Children Reintegrating From Orphanages in Azerbaijan
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Savings 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 n60 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 childrens 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 eg depression anxiety PTSD oppositional-defiant disorder and reactive attachment disorder
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 n60 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 childrens 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 eg 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 13 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 NIMH 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 US 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 childs 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
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 NIMH 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 US 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 childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD099847 | NIH | None | httpsreporternihgovquickSearchR01HD099847 |