About this trial
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
This trial accepts healthy volunteersQualifiers
The child is between ages 7 and 14;
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.
Disqualifiers
None
Trial design
Factorial
Treatments tested in this trial
Usual Care
BehavioralAll 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.
Family Strengthening
BehavioralFamilies 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.
Mental Health Screening, Referral and Connection to Services
BehavioralChildren 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.
Economic Empowerment
Other interventionChild 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.
Treatment groups
8
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
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.
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.
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)
Secondary outcomes
Change in cognitive functioning using Cambridge Neuropsychological Test Automated Battery
Cambridge Neuropsychological Test Automated Battery (CANTAB) of computer-based non-linguistic tasks that provide understanding of brain functions (Attention, Cognitive Control-Response Inhibition, Impulsivity). Children complete Emotional Bias Task (min: 0, max: 15), Motor Screening Task (min: 0, max: 6000), Reaction Time (min: 0, max: 5100), Stockings of Cambridge (min: 0, max: 12), and Spatial Span (min: 2, max: 9). Higher scores indicate better outcomes.
Change in school attendance
School attendance is collected from teachers and school records. Minimum score is 0 and maximum is the number of days in the school year (varies).
Change in cognitive functioning using Wechsler Intelligence Scale for Children (Fifth Edition)
The Wechsler Intelligence Scale for Children (Fifth Edition) is an intelligence test designed to assess the cognitive abilities in children. Children complete Block Design task, which assesses ability to visualize and manipulate spatial forms. Maximum scaled score is 19. Minimum scaled score is 1. A higher score indicates a better outcome.
Change in grade average
Change in school grades is collected from school academic records (report cards). The minimum grade is 0 and the maximum is 5. Higher grades indicate better outcomes.
Sponsors and contacts
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University of Chicago
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator