Multi-level Child Mental Health Interventions in Azerbaijan

NCT06788028 | Recruiting DMC

• 2 other identifiers: IRB24-1074R01MH135095
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 2

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.

Conditions

Mental Health; Child Externalizing Problems; Child Behavior Problem

Keywords

Azerbaijan; Children; Child Mental Health; Family Strengthening; Economic Empowerment; Child and Family Well-being

Outcome Measures

Primary Outcomes (3)

• Change in child mental health using the Strengths and Difficulties Questionnaire (SDQ)

  Questions assess child's internalizing problems (depression, anxiety) and externalizing problems (aggressive or disruptive behavior). Strengths and Difficulties Questionnaire includes five scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behaviors reported by parent/caregiver and teacher. With the exception of prosocial behaviors, a higher score indicates a worse outcome. For the prosocial scale, a higher score indicates a better outcome. The total score minimum value is 0 and maximum is 40. For all subscales, minimum value is 0 and maximum is 10.

  Baseline, 12 months, 24 months

• Changes in child's post-traumatic symptoms using the Revised Child Impact of Events Scale

  Revised Child Impact of Events Scale (CRIES-8) is a 8-item child-friendly measure designed to screen children at risk for Post-Traumatic Stress Disorder (PTSD). the CRIES-8 has two sub-scales (Intrusion and Avoidance). Total scores range from 0 to 40, with higher scores indicated higher PTSD symptoms. A reduction in trauma symptoms would indicate improvement.

  Baseline, 12 months, 24 months

• Change in child mental health using the Revised Children's Anxiety and Depression Scale (RCADS)

  The Revised Children's Anxiety and Depression Scale (RCADS) is a self- and parent-reported measure that assesses a child's internalizing problems, specifically symptoms of anxiety and depression. Sub-scales assess for separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). Results produce a total anxiety score and total internalizing score. Higher scores indicate worse outcomes and a greater severity of anxiety or depression. For the total scale, the maximum score is 141 and the minimum is 0. For the sub scales: Generalized Anxiety Disorder (0 to 15), Social Phobia (0 to 15), Separation Anxiety Disorder (0 to 15), Panic Disorder (0 to 15), Depression (0 to 24)

  Baseline, 12 months, 24 months

Secondary Outcomes (5)

• Change in cognitive functioning using Cambridge Neuropsychological Test Automated Battery

  Baseline, 12 months, 24 months

• Change in school attendance

  Baseline, 12 months, 24 months

• Change in cognitive functioning using Wechsler Intelligence Scale for Children (Fifth Edition)

  Baseline, 12 months, 24 months

• Change in grade average

  Baseline, 12 months, 24 months

• Change in school problem behavior

  Baseline, 12 months, 24 months

Study Arms (8)

Family Strengthening, Mental Health, Economic Empowerment

EXPERIMENTAL

Group will receive: 1) Usual Care, 2) Family Strengthening, 3) Trauma-focused Mental Health Services, and 4) Economic Empowerment Interventions

Behavioral: Family Strengthening; Behavioral: Mental Health Screening, Referral and Connection to Services; Other: Economic Empowerment

Family Strengthening, Mental Health

EXPERIMENTAL

Group will receive: 1) Usual Care, 2) Family Strengthening, and 3) Trauma-focused Mental Health Services

Behavioral: Family Strengthening; Behavioral: Mental Health Screening, Referral and Connection to Services

Family Strengthening, Economic Empowerment

EXPERIMENTAL

Group will receive: 1) Usual Care, 2) Family Strengthening, and 3) Economic Empowerment Interventions

Behavioral: Family Strengthening; Other: Economic Empowerment

Family Strengthening Only

EXPERIMENTAL

Group will receive: 1) Usual Care and 2) Family Strengthening Interventions

Behavioral: Family Strengthening

Mental Health, Economic Empowerment

EXPERIMENTAL

Group will receive: 1) Usual Care, 2) Trauma-focused Mental Health Services, and 3) Economic Empowerment Interventions

Behavioral: Mental Health Screening, Referral and Connection to Services; Other: Economic Empowerment

Mental Health Only

EXPERIMENTAL

Group will receive: 1) Usual Care and 2) Trauma-focused Mental Health Services

Behavioral: Mental Health Screening, Referral and Connection to Services

Economic Empowerment Only

EXPERIMENTAL

Group will receive: 1) Usual Care and 2) Economic Empowerment Interventions

Other: Economic Empowerment

Usual Care Only

EXPERIMENTAL

Group will receive: Usual Care Intervention only

Behavioral: Usual Care

Interventions

Usual Care BEHAVIORAL

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.

Usual Care Only

Family Strengthening BEHAVIORAL

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.

Family Strengthening Only; Family Strengthening, Economic Empowerment; Family Strengthening, Mental Health; Family Strengthening, Mental Health, Economic Empowerment

Mental Health Screening, Referral and Connection to Services BEHAVIORAL

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.

Family Strengthening, Mental Health; Family Strengthening, Mental Health, Economic Empowerment; Mental Health Only; Mental Health, Economic Empowerment

Economic Empowerment OTHER

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.

Economic Empowerment Only; Family Strengthening, Economic Empowerment; Family Strengthening, Mental Health, Economic Empowerment; Mental Health, Economic Empowerment

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child is between ages 7 and 14;
• The child is at-risk for mental health problems as measured by one of the following criteria:
• 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
• 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);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

National Mental Health Centre under the Ministry of Health

Baku, Azerbaijan, Azerbaijan

RECRUITING

Research and Education Center

Baku, Azerbaijan, Azerbaijan

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Leyla Ismayilova, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leyla Ismayilova, PhD

CONTACT

773-834-0401; leyla@uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will use a randomized design and apply MOST approach to test and compare the three intervention components: a) a family-strengthening intervention (yes or no); b) trauma-focused mental health services (yes or no); and c) economic empowerment in the form of Child Savings Accounts /Child Development Accounts-CDAs (yes or no). There are three factors (intervention components) and each factor has two levels. This is a 2\*2\*2, or 23, factorial design and, therefore, the study will have eight different experimental conditions or groups (2\*3 = 8). All participating families are eligible to receive the government-based usual care. The eligible and consenting child-parent dyads (N=600) will be randomly assigned to one of eight study groups, determining how many and which intervention components participants will receive. Given this design, half of the sample will receive each intervention component.

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 22, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Once all of the data have been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. Upon completion of the deliverable(s), the requestor will be instructed to destroy all copies of the data. If deliverables have not been produced yet, the agreement to share data will be revisited annually to decide to continue sharing or terminate the sharing agreement. If the Investigators determine that the sharing agreement should be terminated, the requestor will be instructed to destroy all copies of the data.
• Access Criteria: The University of Chicago has a data sharing agreement that specifies the following conditions be met before data are shared: 1. A formal research question is specified a priori; 2. Names, affiliations, and roles of any other individuals who will access the shared data; 3. The deliverable(s) (e.g., manuscript, conference presentation) are specified a priori; 4. Proper credit and attribution-e.g., authorship, co-authorship, and order-for each deliverable are specified a priori; 5. A statement indicating an understanding that the data can not be further shared with any additional individual(s) or parties without the PI's permission; 6. Institutional Review Board (IRB) approval for use of the data (or documentation that IRB has determined the research is exempt);

Locations

AZ (2)