
IS YOUR CHILD EXPERIENCING MOOD DIFFICULTIES?
Volunteers are needed to examine the effects of the spice saffron in children aged 6 to 11 years who are experiencing low mood/ mood swings.
This is a registered clinical trial with the Australian and New Zealand Clinical Trials Registry
PLEASE NOTE: No travel is required for this study. All assessments are completed online.
Saffron is a dietary spice that has been shown in several studies to improve mood, overall wellbeing, and sleep quality in adults and teens. In this study, we are interested in examining its effects on mood and sleep in children aged 6 to 11 years experiencing low mood.
If your child is aged between 6 and 11 years and experiencing low mood, irritability, or mood swings, we invite you and your child to participate in this randomised, controlled study.
Eligible participants will be RANDOMLY allocated into ONE of TWO treatment conditions:
- Daily intake of chewable tablets containing saffron, or
- Daily intake of placebo (fake) chewable tablets
This 4-week study consists of the following:
- You will participate in a 10-minute phone interview with a researcher to discuss the study and assess your child’s eligibility to participate.
- You and your child will complete a study consent form to ensure you both agree to participate in this study
- Your child will take ONE chewable tablet, TWICE daily for 6 weeks
- You will complete a daily rating of your child’s mood. This will be sent to your phone every evening and will take less than a minute to complete.
- You and your child will complete a series of questionnaires asking about your child’s mood and sleep. This will be completed online every 2 weeks and will take less than 10 minutes.
You can download the full STUDY INFORMATION SHEET by clicking the button on this webpage
To compensate you and your child for the time involved in this study, we will send you a $150 gift voucher at the end of the study.
To be INCLUDED in the study, the following inclusion criteria must be met:
- Males & females aged 6 to 11 years.
- Parent-reported emotional difficulties in the child.
- Child attends mainstream schooling/ classes.
- Child has a healthy body mass index.
- Child and parent understand, are willing, and are able to comply with all study procedures.
- Child is willing and able to take the prescribed placebo/saffron tablets.
- Child lives with the reporting parent for at least 5 days a week.
If any of the exclusion criteria below are met, the applicant will not be suitable for participation in this study:
- Child has a known allergy to saffron.
- Child is currently receiving treatment for emotional or behaviour-related difficulties, or there is a plan to start a new treatment during the study period.
- Child has a diagnosis of a sleep disorder, including but not limited to, insomnia, night terrors, and/or sleepwalking.
- Child has a medical/physical condition that significantly affects daily function.
- Child has been diagnosed with a psychiatric condition that significantly affects daily function.
- Child engages in self-harm behaviours or has suicidal ideation.
- Child has had any injury, surgery, or illness in the last 3 months that significantly affected his/her daily function.
- Child has been currently taking, or in the last 8 weeks, taken a pharmaceutical medication.
- Child has been currently taking, or in the last 8 weeks, taken a nutritional or herbal supplement that may affect the treatment outcomes.
- Any plan to commence a pharmaceutical medication, nutritional, or herbal supplement during the study period.
- Child is experiencing a significant family or lifestyle stressor that may impact his/her emotional function.
- A planned significant lifestyle, dietary or environmental change during the study period for the child and/or parent.
- Child has participated in a clinical research trial within 30 days.
- Child has a significant learning or cognitive impairment.
- Any other condition which, in the Investigator’s opinion, may adversely affect the child’s and/or parent’s ability to complete the study, its measures, or which may pose a significant risk to the child
This study has been approved by the National Institute of Integrative Medicine (NIIM) Ethics Committee (Reference number: 0162E_2025)
If you are interested in participating in this study, please click on the button "Complete the Study Application Form" located on this webpage. This questionnaire will take aproximately 10 minutes to complete and helps us assess your eligibility to participate in this study.
Please Note: All answers are confidential and will only be seen by study investigators. If you are not eligible to participate in this study, your records will be deleted immediately
If you would like to speak to a researcher to get more information about this study, you can call us on 08 9448 7376
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