Clinical Trials Logo

Clinical Trial Summary

The aim of this feasibility study is to determine whether a nutritional intervention in children and their parents can improve their sleep quality and behavior. The study is a randomized, double-blind, placebo-controlled parallel trial of omega-3 supplementation to children and their mothers.


Clinical Trial Description

Previous studies show omega-3 fatty acid supplements improve adolescent's antisocial behavior. However it is less known whether the same effect could be achieved in younger children. Furthermore it is not known whether omega-3 fatty acids could also improve parental behavior and parenting style which could further reduce behavioral problems in children. Moreover, we recently found that children who consume fish more frequently have less sleep problems but it is not known whether omega-3 supplements could also potentially improve children's sleep. We aim to test several hypotheses in this random controlled trial of omega-3 fatty acids.

The study design will consist of a double-blind, randomized placebo-controlled trial of children and their caregivers in a community sample in the city of Philadelphia. It will utilize a random parallel design, in which child and mother pairs will be randomly assigned to either omega-3 supplementation (treatment condition) or a placebo (control condition). This results in 2 groups: (1) child and caregiver both receiving omega-3 and (2) both parent and child receiving the placebo. Treatment will last 45 days. Assessments will take place at 0 months (baseline), 45 days (end of supplementation) and 90 days (45 days after the end of treatment). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03694314
Study type Interventional
Source University of Pennsylvania
Contact
Status Completed
Phase N/A
Start date May 15, 2018
Completion date June 30, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT04725721 - Testing FIRST in Youth Outpatient Psychotherapy N/A
Completed NCT03687879 - Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum
Completed NCT03599648 - The Pro-Parenting Study: Helping Parents Reduce Behavior Problems in Preschool Children With Developmental Delay N/A
Active, not recruiting NCT03641664 - FCT Study: Reducing the Need for Out-of-Home Placements N/A
Recruiting NCT06228950 - Mindfulness-Based Intervention for Emotional and Behavioural Problems of Students With Visual Impairment N/A
Recruiting NCT05581914 - Effectiveness of the MY LIFE Treatment for Adolescents With Behavioral Problems N/A
Not yet recruiting NCT03260296 - Smartphones Addiction in Assiut University Students N/A
Completed NCT02970565 - Family Nurture Intervention, A Group Model in Connecticut N/A
Recruiting NCT05280613 - The Family Check-Up in Autism Services N/A
Recruiting NCT05603000 - Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties N/A
Completed NCT05008354 - Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam Phase 4
Completed NCT04547192 - Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form N/A
Completed NCT03298724 - Teachers and Parents as Partners During Middle School N/A
Completed NCT03709472 - Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth N/A
Enrolling by invitation NCT04001140 - Enhancement of Emotion Regulation Skills in Adolescents N/A
Not yet recruiting NCT06417125 - Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children Phase 4
Active, not recruiting NCT05856435 - Tailoring CPP for the Foster Care Setting N/A
Recruiting NCT04298437 - Addressing Depression and Positive Parenting Techniques (ADAPT) N/A
Recruiting NCT05667675 - Targeting Child Mental Health and Household Poverty N/A
Recruiting NCT05273320 - Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities Phase 1