Trial results for a study investigating a culturally adapted emotional-behavioral prevention program for American Indian children with anxiety and depressive disorders were posted on ClinicalTrials.gov on 2025-09-04, involving 28 participants.
Background
American Indian youth face a heightened risk for anxiety and depression early in life, conditions that can lead to significant negative effects across the lifespan, including increased rates of substance use and suicide. Despite this critical need, there are limited culturally adapted prevention and early intervention (PEI) programs available for anxiety and depression in this population. The development and evaluation of culturally consonant, brief PEIs are therefore essential to provide communities with effective tools to mitigate anxiety and depressive symptoms in American Indian youth.
Trial design
This completed study, designated as Phase NA, enrolled 28 participants to investigate conditions including Anxiety Disorder and Depressive Disorder. The trial focused on the feasibility of a culturally adapted emotional-behavioral prevention program for American Indian children. The overall goal was to develop and evaluate a culturally consonant, brief prevention and early intervention (PEI) to address anxiety and depression in this youth population.
Key results
The trial reported several key measurements related to post-intervention symptoms, control beliefs, rumination, resilience, and program likability within the Culturally Adapted Prevention and Early Intervention Program group:
- Post-Intervention Youth-reported Anxiety Disorder Symptoms From Pre- to Post-Intervention (mean score on scale):
- A mean score of 0.94 (Standard Deviation 0.65) was observed.
- Mean Likability of the Prevention and Early Intervention Modules (Score on a scale):
- A mean score of 2.43 (Standard Deviation 0.51) was observed.
- A mean score of 2.5 (Standard Deviation 0.51) was observed.
- A mean score of 2.5 (Standard Deviation 0.51) was observed.
- A mean score of 2.6 (Standard Deviation 0.50) was observed.
- A mean score of 2.33 (Standard Deviation 0.57) was observed.
- Post-Intervention Youth-reported Depressive Disorder Symptoms (mean score on scale):
- A mean score of 1.03 (Standard Deviation 0.51) was observed.
- Post-Intervention Youth-reported Anxiety Control Beliefs (mean score on scale):
- A mean score of 2.42 (Standard Deviation 0.66) was observed.
- Post-Intervention Youth-reported Rumination (mean score on scale):
- A mean score of 1.22 (Standard Deviation 0.70) was observed.
- Post-Intervention Youth-reported Personal Skills Resilience (mean score on scale):
- A mean score of 1.35 (Standard Deviation 0.33) was observed.
- Post-Intervention Youth-reported Peer Support Resilience (mean score on scale):
- A mean score of 1.50 (Standard Deviation 0.60) was observed.
- Post-Intervention Youth-reported Social Skills Resilience (mean score on scale):
- A mean score of 1.52 (Standard Deviation 0.36) was observed.
What this means
The posted results provide initial data on the feasibility and preliminary outcomes of a culturally adapted emotional-behavioral prevention program for American Indian children. The measurements include post-intervention symptom scores for anxiety and depression, as well as several indicators of resilience and the reported likability of the program modules. While these mean scores and standard deviations offer initial insights into the program's impact and acceptability, the study's primary focus on feasibility means that no comparative analyses or statistical significance values are available to infer definitive efficacy. These findings contribute to the foundational understanding necessary for developing and evaluating culturally sensitive mental health interventions for this population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05371665, titled "Feasibility of a Culturally Adapted Emotional-Behavioral Prevention Program for American Indian Children", were posted on 2025-09-04 on clinicaltrials.gov.