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NCT06788028: AZ CMH
Multi-level Child Mental Health Interventions in Azerbaijan
NA trial testing Usual Care in Mental Health in 1,200 participants. Currently enrolling.
31 December 2028
Quick facts
| Lead sponsor | University of Chicago |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 1,200 |
| Start date | 1 March 2025 |
| Primary completion | 31 December 2028 |
| Estimated completion | 31 January 2029 |
| Sites | 2 locations across Azerbaijan |
Drugs / interventions tested
- Usual Care
- Family Strengthening
- Mental Health Screening, Referral and Connection to Services
- Economic Empowerment
Conditions studied
- Mental Health — all drugs for Mental Health →
- Child Externalizing Problems — all drugs for Child Externalizing Problems →
- Child Behavior Problem — all drugs for Child Behavior Problem →
Sponsor
University of Chicago
Who can join
Adults 7 to 14, any sex, with Mental Health or Child Externalizing Problems. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06788028
- Europe PMC full search
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- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06788028 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Chicago
- Last refreshed: 6 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06788028.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing