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Recruiting NCT06788028

Multi-level Child Mental Health Interventions in Azerbaijan

Trial Parameters

Condition Mental Health
Sponsor University of Chicago
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,200
Sex ALL
Min Age 7 Years
Max Age 14 Years
Start Date 2025-03-01
Completion 2028-12-31
Interventions
Usual CareFamily StrengtheningMental Health Screening, Referral and Connection to Services

Brief Summary

To improve mental health outcomes among children aged 7-14 from low-income families in Azerbaijan, this study will refine and test three evidence-based intervention approaches: family-strengthening intervention; trauma-focused mental health services; and economic empowerment in the form of Child Savings Accounts. Based on prior research on the mental health of deinstitutionalized children conducted by this U.S.-Azerbaijani team in collaboration with a local Community Collaborative Board, these intervention components have been adapted to maximize fit to the cultural context of Azerbaijan. In this study, the adapted interventions will be tested with 600 child-caregiver dyads in a trial using the Multiphase Optimization Strategy (MOST) to compare different intervention components and identify the most optimal combination. Given the limited human and financial resources in low- and middle-income countries (LMICs), it will be important to identify whether each of these interventions is necessary and/or sufficient for improving the mental health of children. The study will test the effects of each intervention component on children's mental health outcomes (symptoms of depression, anxiety; disruptive behaviors; post-traumatic symptoms;), on associated cognitive and social processes (e.g., attention, emotion recognition bias) and functional outcomes (e.g., academic performance). The study will also examine the mediating pathway associated with each intervention component.

Eligibility 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 Crit

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