Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201707002407325 Date of Approval: 06/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Management of school age children with ADHD
Official scientific title Study of the efficacy of behavioral modification therapy, neurofeedback training or behavioral parent training program as adjuvant therapy for school aged children with Attention Deficit Hyperactivity Disorder.
Brief summary describing the background and objectives of the trial Attention deficit hyperactivity disorder (ADHD) is a disorder that manifests in early childhood with symptoms of hyperactivity, impulsivity, and/or inattention. The symptoms affect cognitive, academic, behavioral, emotional, and social functioning. It is the most common neurodevelopmental and behavioral disorders of childhood. According o The American Academy of Pediatrics, school-aged children (¿6 years) and adolescents who meet diagnostic criteria for ADHD should be treated with medications with or without behavioral/psychological interventions as the first-line therapy. In the current study we allocated 60 school aged children with ADHD to different interventional strategies of management (medications only or in combination with either behavioral therapy, or cognitive training). The primary goal is to individualize the proper management plan for children with ADHD based on his/her core symptoms and co-morbidities. The General objective for this study is to deduce the indicators for better quality of care provided for school aged children with attention deficit hyperactivity disorder attending Alexandria University Children¿s Hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Attention Deficit Hyperactivity Disorder,Mental and Behavioural Disorders,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/01/2014
Actual trial start date 01/02/2016
Anticipated date of last follow up 28/02/2017
Actual Last follow-up date 31/08/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization (variable block size) Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group QEEG based Neurofeedback training (NFT) and non stimulant medication 24 sessions 3 months a kind of biofeedback, aiming to enhance self regulatory capacity over brain activity patterns and consequently over brain mental states. The preceded brain mapping with QEEG helps to individualize the training location and threshold. All 15 studied children had standard protocol of (Inhibiting Theta amplitude (4-8 Hz), muscle movement (43-59 Hz), rewarding Beta 1 (15-21 Hz). Plus reduction of TB 15
Experimental Group Behavioral modification therapy and non stimulant medication 24 sessions 3 months Child focused social skills and attention skills training provided by trained psychologist 15
Experimental Group Behavioral parent training (BPT) and non stimulant medication Training was implemented for the whole group on three days per week for 2 weeks. Each day of training was 6 hours duration (from 9 AM to 3 PM) with 30 minutes break. 3 months BPTs are usually directed at functional impairments targets which often include improving adherence to parental requests, reducing dependence on parents to manage daily routines and lessening defiance toward parental requests. The training program was based on a book ¿Taking Charge of ADHD, Third Edition. The Complete, Authoritative Guide for Parents¿ by Dr. Russell A. Barkley. Handouts 15
Control Group Medication only daily dose of approximately 1.2 mg/kg 3 month Non-stimulant medication (Atomoxetine) started at a dose of 0.5 mg/kg for a minimum of three days and then titrated up to a daily dose of approximately 1.2 mg/kg, within 4 weeks duration, in either one or two daily doses; the maximum daily dose did not exceed 1.4 mg/kg/day or 100 mg/day. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Fulfillment of ADHD DSM-V diagnostic criteria. - Children with moderate or severe functional impairment either in their social or academic performances. - Parent¿s cooperation and informed consent. - IQ test of 85 or more. Contraindications to non-stimulant medications. Lack of parent adherence to therapy. The presence of any dysmorphic features or any neurocutenous manifestation. The presence of any visual, hearing impairment or abnormal neurological findings. The presence of significant psychiatric disorders. 6 Year(s) 10 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/11/2013 IRB, Ethics Committee, Faculty of Medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah, Alexandria, Egypt Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome alleviation of the core symptoms of ADHD and its co-morbidities 6 months
Primary Outcome most appropriate intervention strategy for children with ADHD according to their presenting core symptoms. 6 months
Secondary Outcome implementation tools for ADHD management ( Structural parent training program in Arabic) 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Children (AlHospital Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Pediatric Departement, Faculty of Medicine, Alexandria University Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric Departement, Faculty of Medicine, Alexandria University Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hanan Galal Azouz Camp Chizar Alexandria 21525 Egypt
Tarek ElSayed Omar Semoha Alexandria 21615 Egypt
Faten Abdel Latef Semoha Alexandria 21615 Egypt
Mona Khalil Fouad st Alexandria 21514 Egypt
Marwa Saeed Abdel Maksoud Camp Chizar Alexandria 21525 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hanan Azouz hananazouz@hotmail.com 01010566690 Camp-Chizar
City Postal code Country Position/Affiliation
Alexandria 21525 Egypt Professor of pediatric neurology and behavioral pediatrics
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Tarek Omar tarek.omar@alexmed.edu.eg 01222668880 11 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Professor of pediatric neurology and behavioral pediatrics
REPORTING
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