Dietary Supplement for Stress, Anxiety, Mood, and Sleep in Children
Placebo
+ Dietary Supplement with actives
Supportive Care Study
Summary
Study start date: July 15, 2025
Actual date on which the first participant was enrolled.This study focuses on exploring the effects of a dietary supplement on stress, anxiety, mood, and sleep in children. The aim is to see if this supplement can help improve these aspects of mental and emotional well-being, which are important for healthy development and daily functioning. By addressing these issues in a pediatric population, the study seeks to find new ways to support children who might struggle with stress and sleep problems, potentially offering an alternative to more conventional treatments. Participants in the study will consume the dietary supplement, and researchers will assess its impact by using various scoring systems. These include the Perceived Stress Scale for Children (PSS-C), which measures stress levels, the Positive and Negative Affect Schedule for Children (PANAS-C) that assesses mood, and the Children's Sleep Habits Questionnaire (CSHQ) to evaluate sleep patterns. Each of these tools helps determine if the supplement has a positive or negative effect by looking at changes in scores, where higher scores typically indicate more stress, negative emotions, or disturbed sleep. The study is designed to be interventional, meaning it actively involves participants taking the supplement and observing changes.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 5 to 14 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location