Multi-level Child Mental Health Interventions in Azerbaijan

NCT06788028 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2025-04-06

No results posted yet for this study

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.

Conditions

  • Mental Health
  • Child Externalizing Problems
  • Child Behavior Problem

Interventions

BEHAVIORAL

Usual Care

All participants receive the usual care via standard mental health services offered by the NMHC to the public free of charge. Participants will have access to these public services regardless of whether or not they choose to participate in this study. If they refuse to participate in the research study, they will still have access to usual care.

BEHAVIORAL

Family Strengthening

Families will engage in 12 weekly (1-1.5 hours) of family strengthening sessions, led by trained facilitators from the Research and Education Center. Groups will be composed of approximately 5 caregiver-child dyads. Sessions are designed to improve family functioning, strengthen child-parent relationships, enhance parenting strategies, and prevent emotional and behavioral problems among at-risk children.

BEHAVIORAL

Mental Health Screening, Referral and Connection to Services

Children will receive 12 sessions of individual mental health services. Clinicians are trained in the Attachment, Regulation, and Competency (ARC) framework. Services include a clinical assessment performed by a psychiatrist, development of an individual care plan, and corresponding mental health services, informed by ARC.

OTHER

Economic Empowerment

Child Development Accounts (CDAs) will be opened to facilitate family savings. The project will provide $50 as seed money to open a savings account in the child's name. Savings of up to $20 per month will be matched with study funds at a rate of 2:1 and placed in the CDA account. Caregivers and children will also engage in 12 weekly (1-1.5 hours) of financial education sessions, led by facilitators from the Research and Education Center.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • University of Chicago

    lead OTHER

Principal Investigators

  • Leyla Ismayilova, PhD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2028-12-31
Completion
2029-01-31

Countries

  • Azerbaijan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06788028 on ClinicalTrials.gov