NCT Number: NCT06443918
The goal of this clinical trial is to test an app-based just-in-time-adaptive intervention (JITAI). The intervention aims to improve child and family mental health. A JITAI provides in-the-moment feedback to coach families. The questions it tests are if the app will improve mental health and family functioning. Participants will download an app on their phone and complete JITAI sessions. Researchers will compare intervention and control groups to see if the app improves mental health.
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Notify Me6 year and older
All sexes
Interventional
Not applicable
Florida International University, Miami, Florida, United States
The following study tests the efficacy of an app-based program designed to improve child and family mental health and well-being. The intervention will include family-based activities for improving child and family mental health and functioning delivered as psychoeducation and activities through the smartphone app, as well as a just-in-time adaptive intervention (JITAI) component where AI analysis for family interactions will be used to provide real-time, dynamic feedback to families. Participants will be informed during consent that they will have a 50-50 chance of receiving the intervention. The study will assess caregiver and child functioning in a variety of domains, such as mental health symptoms, attachment style, and family conflict through a series of baseline and follow-up questionnaires. Caregivers may use their own smartphones, or they will be lent smartphones for the study. Caregivers and children will also be lent Fitbits/Apple Watches. The intervention will last 8 weeks. Data will include daily surveys, daily audio recordings, 15-minute surveys every 2 weeks about their experiences using the app, bi-weekly check-ins, psychoeducational modules, homework activities, JITAI sessions, and passively sensed data. The intervention will be administered through the smartphone app and will include daily 5-15-minute psychoeducation modules and practice sessions and daily JITAI sessions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Families meeting these exclusion criteria will undergo a clinical risk assessment and be referred for alternative treatment services.
Families in the intervention group will download an app on their smartphones. The app will deliver psychoeducational modules and family-based homework activities. It will include a component where AI is used to assess the quality of family-based interactions and provide in-the-moment feedback and coaching to guide the family interaction.
Time frame: 8 weeks
Assesses caregiver-reported child internalizing symptoms (e.g., anxiety, depression, withdrawal) using the Child Behavior Checklist (CBCL) Internalizing Problems scale, evaluated as change from baseline to post-intervention follow-up to determine intervention effects on child emotional functioning.
Time frame: 8 weeks
Assesses caregiver-reported child externalizing behaviors (e.g., aggression, rule-breaking) using the Child Behavior Checklist (CBCL) Externalizing Problems scale to characterize broader child functioning and potential spillover effects of the intervention.
Time frame: 8 weeks
Evaluates caregiver psychological distress across multiple symptom domains using the Symptom Checklist-27-Plus (SCL-27-Plus) total score to examine changes in caregiver mental health associated with participation.
Time frame: 8 weeks
Assesses the quality of the child's attachment-related behaviors and relational security within the caregiver-child relationship using the Attachment Style Questionnaire for Latency Age Children to evaluate changes in child attachment functioning
Time frame: 8 weeks
Measures the frequency and severity of aggressive or harsh behaviors occurring within the parent-child relationship using the Conflict Tactics Scale Parent-Child version.
Time frame: 8 weeks
Measures the frequency and severity of aggressive or harsh behaviors occurring within the parent-child relationship using the Conflict Tactics Scale Parent-Child version.
Time frame: 8 weeks
Assesses the occurrence and intensity of conflict and aggressive behaviors between caregivers using the Conflict Tactics Scale (Partner Version; CTS2) partner-report form to characterize changes in inter-parental conflict.
Time frame: 8 weeks
Examines caregiver-reported child anxious/depressed symptoms using the CBCL Anxious/Depressed syndrome subscale to characterize symptom-specific changes over time.
Time frame: 8 weeks
Assesses caregiver-reported child withdrawn/depressed behaviors using the CBCL Withdrawn/Depressed syndrome subscale to evaluate patterns of social withdrawal and depressive features.
Time frame: 8 weeks
Evaluates additional CBCL syndrome-level symptom domains to descriptively characterize broader child symptom profiles and trajectories across the intervention period.
Time frame: 8 weeks
Assesses caregiver psychological symptom patterns across syndrome-level domains of the Symptom Checklist-27-Plus to describe changes in specific areas of caregiver distress.
Time frame: 8 weeks
Evaluates caregiver-reported child physical and health-related symptoms using the Child Health Questionnaire to characterize changes in child health functioning.
Time frame: 8 weeks
Assesses caregiver self-reported physical or somatic symptoms using the Physical Health Questionnaire to examine potential changes in caregiver health status.
Time frame: 8 weeks
Characterizes longitudinal patterns of caregiver- and/or child-reported symptoms collected via repeated daily surveys across the intervention period to examine within-person symptom dynamics.
Time frame: 8 weeks
Describes participant interaction with the digital intervention, including module completion, AI coaching session use, and survey completion, using backend application analytics to characterize adherence and exposure.
Time frame: 8 weeks
Examines proximal changes in self-reported mood and perceived family interaction quality immediately following participant-reported use of intervention skills using in-app daily assessments.
Time frame: 8 weeks
Evaluates short-term changes in mood and perceived family functioning immediately after completion of intervention modules using module-based surveys.
Time frame: 8 weeks
Characterizes participant sentiment derived from AI-assisted coaching interactions using Microsoft Azure natural language processing to detect positive, negative, and neutral sentiment during parent-child play sessions.
Colliga Apps Corp.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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