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Currently accepted at: JMIR Research Protocols

Date Submitted: Mar 20, 2026
Open Peer Review Period: Apr 27, 2026 - Apr 29, 2026
Date Accepted: Jun 2, 2026
(closed for review but you can still tweet)

This paper has been accepted and is currently in production.

It will appear shortly on 10.2196/93033

The final accepted version (not copyedited yet) is in this tab.

Optimizing Multicomponent Interventions to Improve Child Mental Health Following Reintegration from Institutions: Protocol for a Factorial Randomized Trial

  • Leyla Ismayilova; 
  • Narmin Guliyeva; 
  • Fuad Ismayilov; 
  • Emma Heidorn; 
  • Fred Ssewamala; 
  • Kerim Munir; 
  • Deborah Gorman-Smith; 
  • Parvin Muslumzada; 
  • Emily Claypool; 
  • Loren Beard; 
  • Donald Hedeker

ABSTRACT

Background:

The legacy of the former Soviet system of childcare has made post-Soviet countries report some of the highest rates of children living in institutions to this day. Often referred to as “social orphans”, many of these children have at least one living parent but are placed in institutions voluntarily by their parents, primarily for socio-economic reasons, including poverty. Given the challenges associated with institutional care on children, including its impact on long-term developmental and mental health outcomes, many countries in the region are implementing deinstitutionalization policies with a strong focus on family reunification. To further support children and families during this transition, these efforts could be strengthened by providing comprehensive support for children's mental health and improving family functioning.

Objective:

This protocol outlines the National Institute of Child Health and Human Development-funded Optimizing Prevention Approaches for Children Reintegrating from Orphanages in Azerbaijan study.

Methods:

This randomized controlled trial employs the Multiphase Optimization Strategy (MOST) to test the effectiveness of three community-based intervention components—family strengthening, child mental health services, and economic empowerment in the form of Child Development Accounts (or Matched Child Saving Accounts)—on improving the mental health outcomes of children with a history of institutional care in the country.

Results:

Recruitment and data collection for this study was complete as of June 2025. The study enrolled 436 children and 305 of their caregiver participants from the three largest cities in Azerbaijan. The majority of caregivers are female (92.46%), predominantly mothers and grandmothers, and families exhibit significant economic instability. Over half of children (52%) exhibit depressive symptoms, nearly 40% exhibit symptoms of PTSD, and over one-third exhibit symptoms of ADHD. Analysis of baseline data suggest that economic instability, parental stress, and family environment appear to play important roles in child outcomes among this population. Specifically, economic deprivation is positively associated with parental distress (β = 0.38, p < .001) which, in turn, was negatively associated with a supportive family environment (β = -0.69, p< .001). A more supportive family environment was linked to fewer child internalizing problems (β = -0.54, p < .001).

Conclusions:

These findings provide important evidence to support deinstitutionalization and family reunification initiatives in the region and strengthen the global evidence base on effective community-based interventions addressing multilevel determinants of mental health among at-risk children in low- and middle-income countries. These efforts are important because most of the mental health challenges that show up in older age could be prevented if children are intervened on early in their life. Clinical Trial: The study is registered with [ClinicalTrials.gov] [NCT05396625]; [https://clinicaltrials.gov/study/NCT05396625]


 Citation

Please cite as:

Ismayilova L, Guliyeva N, Ismayilov F, Heidorn E, Ssewamala F, Munir K, Gorman-Smith D, Muslumzada P, Claypool E, Beard L, Hedeker D

Optimizing Multicomponent Interventions to Improve Child Mental Health Following Reintegration from Institutions: Protocol for a Factorial Randomized Trial

JMIR Research Protocols. 02/06/2026:93033 (forthcoming/in press)

DOI: 10.2196/93033

URL: https://preprints.jmir.org/preprint/93033

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