A two arm randomized controlled trial comparing the short and long term effects of an elimination diet and a healthy diet in children with ADHD (TRACE study). Rationale, study design and methods

Table 3 Outcome Parameters from Baseline to 12 Months after Baseline

Measurement	Time^a	Instrument
Descriptives
Prior beliefs	T0, T1	5-item questionnaire
IQ	T0	WPPSI-III or WISC-III
Demographics	T0	Separate questions
Parental psychopathology	T0, T2, T3	GHQ
Parental ADHD symptoms	T0	ADHD Rating Scale
Primary outcome
Respondership	T1, T4	SWAN, SDQ
Secondary outcomes
Blinded ADHD assessment	T0, T1, T4	DB-DOS
Parent & teacher comorbidity ratings	T0, T1, T4	SDQ, CSBQ, BRIEF, UPPS-P, EDI
Cognitive performance	T0, T1, T4	COTAPP
School performance	T0, T4	Monitoring system Dutch education
Motor activity and sleep pattern	T0, T1, T4	Actigraph
Physical measurements	T0, T1, T4	Weight, height, blood pressure, heart rate
Somatic complaints	T0, T1, T2, T3, T4	Pittsburgh side-effects rating scale
Sleep problems	T0, T1, T2, T3, T4	5-item questionnaire
Quality of life	T0, T1, T2, T3, T4	EQ-5D
Food consumption & eating habits	T0	Questionnaire dietary pattern
	T0, T4	Nutritional assessment (‘Eetmeter’)
Nutritional quality	T0, T2, T3, T4	Nutritional assessment (‘Eetmeter’)^b
	T0, T1, T2, T3, T4	Expert view
	T0, T1, T4	Blood sample
Carer-related quality of life	T0, T1, T2, T3, T4	CarerQol, PSQ
Parenting styles and family functioning	T0, T1, T4	FFQ, BSBP
Adherence	T1, T4	Morisky Adherence Scale, food diary, separate questions
Satisfaction	T1, T4	GGZ-Thermometer
Cost measurements	T1, T2, T3, T4	Tic-P

WPPSS-III Wechsler Preschool and Primary Scale of Intelligence, WISC-III Wechsler Intelligence Scale for Children, GHQ General Health Questionnaire, SWAN Strengths and Weaknesses of ADHD-symptoms and Normal-behaviors (SWAN) rating scale, SDQ Strength and Difficulties Questionnaire, DB-DOS Disruptive Behavior Diagnostic Observation Schedule, CSBQ Children’s Social Behavior Questionnaire, BRIEF Behavior Rating Inventory of Executive Function, UPPS-P Urgency, Premeditation, Perseverance, Sensation seeking, and Positive urgency Impulsivity scale, EDI Emotion Dysregulation Inventory, COTAPP Cognitive Task Application, PSQ Parenting Stress Questionnaire, EQ-5D EuroQol Five Dimensions Health Questionnaire, FFQ Family Functioning Questionnaire, BSBP Brief Scale of Parental Behavior, Tic-P Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness’
^aT0 baseline; T1 five weeks after baseline; T2 four months after baseline; T3 eight months after baseline; T4 12 months after baseline. ^b Only parents of healthy diet participants who continue the diet after five weeks, register food consumption at T2 and T3

ISSN: 1471-244X