Improving child mental health in Azerbaijan through community interventions
Optimizing Multi-level Interventions to Improve Child Mental Health in Azerbaijan
This study is testing different support programs to see which combination can best improve the mental health of children aged 7-14 from low-income families in Azerbaijan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 7 Years to 14 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 2 sites (Baku, Azerbaijan and 1 other locations) |
| Trial ID | NCT06788028 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance mental health outcomes for children aged 7-14 from low-income families in Azerbaijan by testing three evidence-based interventions: family-strengthening, trauma-focused mental health services, and economic empowerment through Child Savings Accounts. The interventions have been culturally adapted based on prior research and will be evaluated using the Multiphase Optimization Strategy (MOST) with 600 child-caregiver dyads. The goal is to identify the most effective combination of these interventions to address the mental health needs of children facing economic hardship and trauma.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 7-14 who are at risk for mental health problems due to elevated emotional or behavioral issues or parental distress.
Not a fit: Patients who do not meet the age criteria or do not exhibit risk factors for mental health problems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the mental health and overall well-being of children in low-income families in Azerbaijan.
How similar studies have performed: Previous studies have shown success with similar community-based mental health interventions, indicating potential for positive outcomes in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The child is between ages 7 and 14; 2. The child is at-risk for mental health problems as measured by one of the following criteria: 1. Elevated child emotional behavioral problems as indexed by 'high' or 'very high' scores on the Strengths and Difficulties Questionnaire (SDQ, total difficulty score or any of the four difficulty subscales - emotional, conduct, hyperactivity, or peer problems); OR 2. Parental risk factor - parental elevated emotional distress, as indexed by 'severe' or 'extremely severe" score on any of the DASS-21 subscales (DASS-21 Stress = 27; Anxiety = 15; or Depression = 15); 3. The child and parent (or other primary caregiver) can commit to study participation. If a family has more than one eligible child, participation in the study will be offered to the older child. If both the eligible child and caregiver provide consent, they will be enrolled in the study. All eligible children within a family can be enrolled in the study. Exclusion Criteria: Participants will be excluded from participation in the study if the child, the parent or the participating caregiver is assessed to have a cognitive impairment that would interfere with their ability to provide informed consent. This will be assessed during the consent process. As part of the informed consent process, conducted through an Azeri speaking research assistant, potential participants will also be asked to state their understanding of areas addressed during the informed consent discussion including (1) the nature and extent of participation in the study; (2) risks involved with participation; and (3) the potential benefits of participation in the study. If a participant is unable to respond to any of the three items, this youth/caregiver pair will be excluded from the study. Children and parents will also be excluded if one of them has significant behavioral, and/or mental health impairment (e.g., development disorder, autism, psychosis, high symptoms of trauma or depression) that could interfere with either with their ability to benefit from the prevention program or to participate safely. Research Assistants will ask parents about any of these conditions during the screening process.
Where this trial is running
Baku, Azerbaijan and 1 other locations
- National Mental Health Centre under the Ministry of Health — Baku, Azerbaijan, Azerbaijan (Recruiting)
- Research and Education Center — Baku, Azerbaijan, Azerbaijan (Recruiting)
Study contacts
- Principal investigator: Leyla Ismayilova, PhD — University of Chicago
- Study coordinator: Leyla Ismayilova, PhD
- Email: leyla@uchicago.edu
- Phone: 773-834-0401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.