Improving child mental health in Azerbaijan through community interventions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.