Attention Deficit Hyperactivity Disorder (ADHD) in children and their mothers Mental and Behavioural Disorders Hyperkinetic disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All patients: 1. Voluntary and written informed consent of the mother, the child and other persons having the care and custody of the child Children: 1. Aged six to 12 years 2. Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria 3. No medication or on stable medication for at least four weeks before baseline assessment Mothers: 1. Diagnosis of ADHD according to DSM-IV criteria 2. A score of 30 or more on the short version of the Wender-Utah-Rating-Scale 3. Aged 18 to 60 years, inclusive 4. Chronic course of ADHD symptoms from childhood to adulthood, onset of ADHD symptoms before the age of seven 5. No abnormality detected on physical examination, routine blood testing (blood count, renal, hepatic and thyroid function), Electrocardiogram (ECG) and Electroencephalogram (EEG)
Exclusion criteria
Exclusion criteria: All patients: 1. Participation in another clinical trial 2. Specific interventions for the treatment of ADHD within the last six months before screening 3. Need for inpatient treatment Children: 1. Intelligence Quotient (IQ) less than 80 2. Pervasive developmental disorder, psychosis, schizophrenia, bipolar disorder, severe depressive episode Mothers: 1. IQ less than 80 2. Schizophrenia, bipolar disorder, borderline personality disorder, antisocial personality disorder, suicidal or self-injurious behaviour, autism, motor tics, Tourette's syndrome 3. Substance abuse/dependence within six months prior to screening. Episodic abuse is not an exclusion criterion 4. Neurological diseases, seizures, glaucoma, uncontrolled hypertension 5. Current eating disorder/low weight (Body Mass Index [BMI] less than 20) 6. Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the extent of externalising symptoms in the children: 1. ADHD-ODD-Scale (ODD: Oppositional Defiant Disorder): number of symptoms of ADHD and ODD present during the last two weeks before assessment (ADHD-section and ODD-section of the Kiddie Schedule for Affective Disorders and Schizophrenia [KIDDIE-SADS], blind investigator-rating) | — |
Secondary
| Measure | Time frame |
|---|---|
| Children: 1. ADHD-section and ODD-section of the KIDDIE-SADS (diagnosis +/-, responders-nonresponders: 30 percent reduction of the ADHD-ODD-Scale, blind investigator-rating) 2. Externalising and internalising symptoms: Strength and Difficulties Questionnaire (SDQ) (mother and teacher report) 3. Family functioning: Home-Situations-Questionnaire (HSQ, mother-report) 4. Impact of the child's symptoms on the family: Family Impact Questionnaire (FIQ, mother-report) 5. Process-quality, related to parent training (Fragebogen zur Beurteilung der Behandlung, FBB, mother- and therapist-report) Mothers: 1. Symptom-Checklist (SCL-90-R, self-rating mother) 2. Conners Adult ADHD Rating Scale (CAARS-S:L, self-rating mother; CAARS-O:L, blind investigator rating) | — |
Countries
Germany