Actively Recruiting

Phase Not Applicable
Age: 7Years - 14Years
All Genders
Healthy Volunteers
NCT06788028

Multi-level Child Mental Health Interventions in Azerbaijan

Led by University of Chicago ยท Updated on 2025-04-06

1200

Participants Needed

2

Research Sites

204 weeks

Total Duration

On this page

Sponsors

U

University of Chicago

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Multi-level Child Mental Health Interventions in Azerbaijan

Who Can Participate

Age: 7Years - 14Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child is between 7 and 14 years old
  • Child is at risk for mental health problems based on high scores on the Strengths and Difficulties Questionnaire or caregiver's severe emotional distress
  • Child and primary caregiver can commit to participating in the study
  • If multiple children in a family are eligible, the older child is offered participation
  • All eligible children in a family can be enrolled
Not Eligible

You will not qualify if you...

  • Child, parent, or caregiver has cognitive impairment preventing informed consent
  • Inability to understand key aspects of study participation, risks, or benefits during consent process
  • Child or caregiver has significant behavioral or mental health impairments such as developmental disorders, autism, psychosis, or severe trauma symptoms that interfere with safe participation or benefit from the program

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

National Mental Health Centre under the Ministry of Health

Baku, Azerbaijan, Azerbaijan

Actively Recruiting

2

Research and Education Center

Baku, Azerbaijan, Azerbaijan

Actively Recruiting

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Research Team

L

Leyla Ismayilova, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

PREVENTION

Number of Arms

8

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