ong term effectiveness and cost-effectiveness of an elimination diet trajectory compared to care as usual in the treatment of Attention Deficit/ Hyperactivity Disorder in children aged 5 to 12 year
Recruiting
- Conditions
- ADHDattention-deficit/hyperactivity disorder10009841
- Registration Number
- NL-OMON41838
- Lead Sponsor
- Psychiatrie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 301
Inclusion Criteria
• clinical ADHD diagnosis according to the DSM-5 (any subtype)
• ADHD treatment abstinence in past 2 months
• 5-12 years old
• ADHD Rating Scale (ARS) score higher than 1.5 SD above the mean
• confirmed research diagnosis by a structured psychiatric interview with the parents (K-SADS) [26].
• comorbidities are allowed, except for eating disorders
Exclusion Criteria
• children with current treatment for ADHD, or in the past two months (either receiving medication or behavioral therapy or a diet),
• use of any other psychotropic medication, elimination diets, behavioral therapies
• children and/or parents with inadequate mastery of the Dutch language
• diabetes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome: % children showing excellent response (>30% symptom reduction)<br /><br>based on blind assessment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>ADHD and comorbid behavior rated by parents and teachers, objective cognitive<br /><br>measures and motor activity, school functioning, quality of life, health<br /><br>status, adequacy of final diet assessed by a dietician and cost-effectiveness.</p><br>