This study, titled "The Effect of the MIND Diet on ADHD Symptom Severity in Children with ADHD Not on Pharmacotherapy: A Randomized Controlled Trial in Lebanon," aims to evaluate whether a structured dietary intervention can improve behavioral and cognitive outcomes in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). ADHD is one of the most common neurodevelopmental disorders in childhood and is characterized by persistent patterns of inattention, hyperactivity, and impulsivity that interfere with academic performance, social functioning, and daily activities. Although pharmacological treatments such as stimulant medications are considered the standard approach for ADHD management, many families either prefer to delay medication use or avoid it altogether due to concerns about side effects, stigma, or personal preferences. Consequently, there is growing interest in complementary and non-pharmacological approaches that may help manage symptoms and improve quality of life for children with ADHD.

The present study investigates the potential benefits of the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay), a dietary pattern that combines elements of the Mediterranean diet and the DASH diet. The MIND diet emphasizes foods associated with brain health and anti-inflammatory properties, including green leafy vegetables, berries, nuts, whole grains, olive oil, fish, legumes, and poultry, while limiting foods that may negatively affect cognitive function such as processed foods, fried foods, red meats, and sweets. Although the MIND diet has demonstrated neuroprotective effects in adults, particularly in relation to cognitive decline and neurodegenerative diseases, its potential role in managing ADHD symptoms in children remains largely unexplored. This study therefore seeks to address an important gap in the literature by evaluating whether dietary patterns that support brain health can influence behavioral and cognitive outcomes in pediatric ADHD.

The research employs a two-arm randomized controlled trial (RCT) design and will recruit a total of 158 children aged 6-12 years who have been diagnosed with ADHD and are not currently receiving pharmacological treatment. Participants will be randomly assigned in a 1:1 ratio to either the intervention group, which will follow the MIND diet, or a control group, which will receive general dietary advice based on standard nutritional recommendations. The intervention will last for 12 weeks, with data collected at baseline and at monthly follow-up visits throughout the study. During the intervention, families in the MIND diet group will receive education sessions from a nutritionist, educational materials including recipes and meal plans, and biweekly phone calls to support adherence and address any difficulties in implementing the diet.

The primary outcome of the study is the change in ADHD symptom severity, measured using the ADHD Rating Scale-IV (ADHD-RS-IV), a validated instrument completed by both parents and teachers. Assessing symptoms from both home and school settings provides a comprehensive evaluation of behavioral changes over time. Secondary outcomes include measures of executive functioning, assessed using the Behavior Rating Inventory of Executive Function (BRIEF) and selected tasks from the Cambridge Neuropsychological Test Automated Battery (CANTAB). These tools allow the study to evaluate both subjective and objective aspects of cognitive functioning, including working memory, planning, and inhibitory control.

Additional outcomes include assessments of quality of life, physical health, and dietary adherence. Quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL), while broader emotional and behavioral functioning will be evaluated using the Strengths and Difficulties Questionnaire (SDQ). Anthropometric measurements such as height, weight, and body mass index (BMI) will be recorded throughout the study to assess potential physical health changes associated with the dietary intervention. Dietary adherence will be monitored using repeated dietary records and a sociodemographic and barriers questionnaire designed to identify factors influencing families' ability to follow the diet. These analyses will also explore predictors of adherence, including caregiver involvement, socioeconomic status, and the child's age.

The study is particularly relevant within the Lebanese and broader Middle East and North Africa (MENA) context, where stigma surrounding mental health and concerns about medication often contribute to underutilization of mental health services. By examining a culturally acceptable and accessible intervention based on widely available foods, the study aims to provide families with an alternative or complementary strategy for ADHD management.

Overall, this research seeks to determine whether adherence to the MIND diet can reduce ADHD symptom severity, improve executive function

Background and Rationale Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most prevalent neurodevelopmental disorders affecting children worldwide. It is characterized by persistent patterns of inattention, hyperactivity, and impulsivity that interfere with development and functioning across multiple settings, including home, school, and social environments. Children with ADHD frequently experience difficulties in academic performance, behavioral regulation, executive functioning, and interpersonal relationships. In addition to these immediate challenges, untreated ADHD may lead to long-term consequences including poor educational attainment, social difficulties, substance use, and psychiatric comorbidities in adolescence and adulthood.

Standard treatment for ADHD typically involves pharmacological therapy, most commonly stimulant medications, combined with behavioral and psychosocial interventions. Pharmacotherapy has been consistently shown to reduce core ADHD symptoms and improve functioning in many patients. Despite its effectiveness, medication treatment is not always acceptable or accessible for all families. Some parents express concerns about potential side effects, long-term medication use, or the stigma associated with psychiatric treatment. In certain cultural contexts, including the Middle East and North Africa region, stigma related to mental health conditions and psychiatric medication can further contribute to delays in treatment initiation.

As a result, there has been increasing interest in non-pharmacological approaches that may complement or serve as alternatives to traditional ADHD treatments. Lifestyle factors such as diet, sleep, and physical activity have emerged as potential contributors to cognitive and behavioral functioning in children. In particular, nutrition has gained attention as a potentially modifiable factor influencing neurodevelopment and mental health outcomes.

Dietary patterns can influence brain health through several biological pathways, including inflammation, oxidative stress, and neurotransmitter synthesis. Diets rich in whole foods, antioxidants, and unsaturated fats have been associated with improved cognitive functioning and mental well-being. Conversely, diets high in processed foods, saturated fats, and refined sugars have been linked to poorer cognitive outcomes and increased behavioral problems in children.

The MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) is a dietary pattern specifically designed to promote brain health and reduce cognitive decline. It combines elements from two well-established dietary patterns: the Mediterranean diet and the Dietary Approaches to Stop Hypertension (DASH) diet. The MIND diet emphasizes the consumption of foods associated with neuroprotection and anti-inflammatory effects, including green leafy vegetables, berries, nuts, whole grains, olive oil, legumes, fish, and poultry. At the same time, it encourages limiting foods that may negatively affect cognitive health, such as fried foods, red meats, processed foods, butter, and sweets.

Although the MIND diet has demonstrated beneficial effects on cognitive aging and neurodegenerative diseases in adult populations, its potential role in pediatric neurodevelopmental disorders has not yet been thoroughly investigated. ADHD has been associated with neurobiological mechanisms that involve inflammation, oxidative stress, and altered neurotransmitter pathways. Because the MIND diet contains foods rich in antioxidants, polyphenols, omega-3 fatty acids, and other nutrients that support brain health, it may represent a promising intervention for improving ADHD symptoms and cognitive functioning in children.

Furthermore, the dietary components emphasized in the MIND diet are largely consistent with traditional Mediterranean dietary patterns commonly found in Lebanon and neighboring countries. This cultural compatibility may facilitate the implementation and sustainability of the intervention among families in the region.

The present study therefore seeks to evaluate whether adherence to the MIND diet can reduce ADHD symptom severity and improve cognitive and behavioral functioning in children diagnosed with ADHD who are not currently receiving pharmacological treatment.

Study Objectives Primary Objective The primary objective of this study is to determine whether adherence to the MIND diet leads to a reduction in ADHD symptom severity among children diagnosed with ADHD who are not currently receiving pharmacological treatment.

Secondary Objectives

Several secondary objectives will also be investigated:

• To evaluate the impact of the MIND diet on executive functioning in children with ADHD.
• To assess changes in cognitive performance using objective neuropsychological testing.
• To examine whether the dietary intervention improves quality of life and psychosocial functioning.
• To assess whether the intervention influences physical health indicators such as body mass index.
• To evaluate adherence to the dietary intervention and identify barriers to maintaining the diet.
• To explore sociodemographic and environmental factors associated with successful adherence to the MIND diet.

Study Hypothesis The study hypothesizes that children who follow the MIND diet will demonstrate a greater reduction in ADHD symptoms compared with children receiving general dietary advice. Additionally, the intervention group is expected to show improvements in executive functioning, cognitive performance, and overall quality of life.

Study Design This research will be conducted as a randomized controlled trial (RCT) with two parallel arms.

Participants will be randomly assigned to one of two groups:

Intervention Group: Participants will follow the MIND diet for the duration of the study.

Control Group: Participants will receive general dietary guidance based on standard healthy eating recommendations.

Randomization will be performed using a computer-generated randomization sequence to ensure unbiased allocation of participants to each study arm. Allocation will occur in a 1:1 ratio, ensuring equal distribution of participants across the intervention and control groups.

The intervention will last 12 weeks (three months). Participants will undergo assessments at baseline and at regular intervals throughout the intervention period in order to evaluate changes in ADHD symptoms and other outcomes over time.

Study Population Target Population The target population for this study consists of children aged 6 to 12 years who have been diagnosed with ADHD according to the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

Sample Size A total of 158 participants will be recruited for the study. This sample size was determined based on statistical power calculations designed to detect a clinically meaningful reduction in ADHD symptom severity between the intervention and control groups.

Participants will be evenly divided between the two study arms, with approximately 79 children in each group.

Recruitment Participants will be recruited primarily from the Department of Psychiatry at the American University of Beirut Medical Center (AUBMC). Children who receive a clinical diagnosis of ADHD during routine psychiatric evaluation may be invited to participate in the study if they meet eligibility criteria.

Recruitment is expected to occur over a period of approximately two years. Inclusion and Exclusion Criteria Inclusion Criteria

Participants must meet the following criteria:

• Children aged between 6 and 12 years
• Diagnosis of ADHD based on DSM-5 diagnostic criteria
• Not currently receiving pharmacological treatment for ADHD
• Willingness of both the child and caregiver to participate in the study
• Caregivers willing to follow the dietary intervention and attend study visits Exclusion Criteria

Children may be excluded if they:

• Have medical conditions requiring specialized diets
• Have severe developmental or neurological disorders that may interfere with study participation
• Are currently receiving stimulant or other pharmacological treatment for ADHD Intervention Participants in the intervention group will follow the MIND diet for the duration of the study.

The MIND diet encourages regular consumption of foods associated with brain health, including:

• Green leafy vegetables
• Other vegetables
• Berries
• Nuts
• Whole grains
• Legumes
• Fish
• Poultry
• Olive oil

The diet also recommends limiting the consumption of foods that may negatively affect cognitive functioning, including:

• Fried foods
• Processed foods
• Red meats
• Butter and margarine
• Sweets and sugary foods The dietary intervention will be delivered by a registered nutritionist who is part of the research team.

At the beginning of the study, caregivers will attend an educational session where they will receive detailed instructions about the dietary guidelines, recommended food portions, and practical strategies for implementing the diet in daily meals.

Participants will receive educational materials that include:

• Meal planning guides
• Recipes based on the MIND diet
• Lists of recommended and restricted foods
• Practical tips for grocery shopping and meal preparation To support adherence, families in the intervention group will receive biweekly follow-up phone calls from the research team. These calls will help address potential challenges, reinforce dietary recommendations, and monitor compliance.

Participants in the control group will receive general advice regarding healthy eating but will not receive specific instructions about the MIND diet.

Outcome Measures Primary Outcome The primary outcome of the study is ADHD symptom severity. Symptoms will be assessed using the ADHD Rating Scale-IV, an 18-item questionnaire that measures the frequency of ADHD symptoms based on DSM-5 diagnostic criteria. Each item is rated on a four-point scale ranging from "never" to "very often." Both parents and teachers will complete the questionnaire to provide information about symptoms across different environments.

Secondary Outcomes Executive Function Executive functioning will be evaluated using the Behavior Rating Inventory of Executive Function (BRIEF), which assesses domains such as inhibition, working memory, cognitive flexibility, and planning.

Cognitive Performance Objective neuropsychological functioning will be assessed using tasks from the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Quality of Life Children's quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL).

Behavioral and Emotional Functioning Emotional and behavioral difficulties will be assessed using the Strengths and Difficulties Questionnaire (SDQ).

Dietary Adherence Adherence to the dietary intervention will be assessed through repeated 24-hour dietary recall records.

Sociodemographic and Environmental Factors Participants will complete questionnaires assessing sociodemographic characteristics and potential barriers to adherence, including financial constraints, food availability, and caregiver involvement.

Physical Health Measures Anthropometric measurements including height, weight, and body mass index (BMI) will be recorded at baseline and at the end of the study.

Data Collection Timeline

Data will be collected at several time points:

• Baseline assessment before the intervention begins
• Monthly follow-up assessments during the three-month intervention
• Final assessment at the end of the intervention period This repeated-measures design will allow researchers to monitor changes in ADHD symptoms and cognitive functioning over time.

Potential Challenges and Mitigation Strategies One potential challenge is adherence to the dietary intervention. Families may encounter barriers such as cost, limited food availability, or children's resistance to dietary changes. To mitigate these challenges, the study will provide educational resources, meal planning tools, and regular follow-up support.

Another challenge involves potential variability in behavioral therapy among participants. Information about therapy type and frequency will therefore be collected and considered during statistical analysis.

Finally, subjective reporting of symptoms by parents and teachers may introduce bias. To address this limitation, the study incorporates both subjective rating scales and objective neuropsychological assessments.

Significance of the Study This study addresses an important gap in the literature by evaluating the effects of a comprehensive dietary intervention on ADHD symptoms in children. Most existing research has focused on individual nutrients or dietary supplements rather than overall dietary patterns.

By conducting a randomized controlled trial, the study aims to provide stronger evidence regarding the potential role of diet in improving ADHD symptoms and cognitive functioning.

If effective, the findings may support the integration of dietary interventions into comprehensive ADHD management strategies. Such approaches could provide families with accessible, culturally appropriate, and non-pharmacological options for supporting children with ADHD.

The results of this research may therefore contribute to the growing field of nutritional psychiatry and inform future clinical practice, research initiatives, and public health strategies aimed at improving mental health outcomes in children.

Inclusion Criteria:

• Children aged 6 to 12 years at the time of enrollment
• Clinical diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) based on DSM-5 diagnostic criteria
• Not currently receiving pharmacological treatment for ADHD
• Child and caregiver willing to participate in the study procedures for the full 12-week intervention period

Exclusion Criteria:

Current use of stimulant or non-stimulant pharmacological treatment for ADHD

• Presence of medical conditions requiring specialized dietary restrictions (e.g., severe food allergies, metabolic disorders, or medically prescribed diets)
• Severe neurological or developmental disorders that may interfere with participation or study assessments
• Serious chronic medical illnesses that may affect growth, nutrition, or participation in dietary interventions
• Inability of caregiver to comply with study procedures or dietary monitoring requirements