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.: PACTR202205632538061 Date of Registration: 18/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Behavioral Sleep Intervention and Sleep Problems among Children with Attention Deficit Hyperactivity Disorder
Official scientific title The Efficacy of Behavioral Sleep Intervention on Sleep Problems among Children with Attention Deficit Hyperactivity Disorder: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial The proposed study aims to measure the efficacy of behavioral sleep intervention on sleep problems, QoL, and ADHD symptom severity among children with ADHD. We hypothesized that the intervention would improve sleep problems (primary outcome) and QoL (secondary outcome) and would reduce ADHD symptom severity (secondary outcome).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial behavioral sleep intervention on sleep problems, QoL, and ADHD symptom severity among children with ADHD
Anticipated trial start date 01/05/2022
Actual trial start date
Anticipated date of last follow up 01/08/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Completed
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 Dynamic (adaptive) random allocation such as minimization Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo No intervention 3 to 6 monthes or more No intervention 25 Placebo
Experimental Group study group behavioral sleep intervention on sleep problems 3 to 6 monthes or more Design The study design is a parallel, two-armed, randomized controlled trial of a behavioral sleep intervention compared with usual clinical care for children with ADHD and sleep problems. Setting The study will be carried out at the child psychiatry settings in Care Center for Psychiatry and Addiction Treatment - Mansoura City and Badr University Hospital-Helwan University, Egypt. Participants To be eligible for the current study, children should be previously diagnosed with ADHD by a child psychiatrist based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (American Psychiatric Association, 2013). Inclusion criteria for children recruited in the study were: school-aged children between 6 and 12 years, having primary diagnosis of ADHD, having at least one problem in sleeping, based on parents' reports using the Children's Sleep Habits Questionnaire (CSHQ) (Owens, Spirito, & McGuinn, 2000), attending child psychiatry settings with their parents who lived together at home. Children and their parents will be interviewed, informed of the study, filled out the written consent, and complete the required questionnaires. Children with documented history of seizures, neurodegenerative disease, head injury, or mental retardation will be excluded. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be eligible for the current study, children should be previously diagnosed with ADHD by a child psychiatrist based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (American Psychiatric Association, 2013). Inclusion criteria for children recruited in the study were: school-aged children between 6 and 12 years, having primary diagnosis of ADHD, having at least one problem in sleeping, based on parents' reports using the Children's Sleep Habits Questionnaire (CSHQ) (Owens, Spirito, & McGuinn, 2000), attending child psychiatry settings with their parents who lived together at home. Children and their parents will be interviewed, informed of the study, filled out the written consent, and complete the required questionnaires. Children with documented history of seizures, neurodegenerative disease, head injury, or mental retardation will be excluded. Child: 6 Year-12 Year 6 Year(s) 12 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 27/04/2022 faculty of nursing mansoura university Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
El Gomhoria Street Mansoura 30016 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The second tool is the Children’s Sleep Habits Questionnaire (CSHQ), the abbreviated version, which assess sleep problems and habits according to children's' caregivers (Owens et al., 2000). The CSHQ composes of 33 items reflecting sleep difficulties and 3 items about time of wake up, bedtime, and duration of sleep. The CSHQ reflects 8 components: daytime sleepiness (8-item), parasomnias (7-item), bedtime resistance (6-item), sleep anxiety (4-item), sleep-disordered breathing (3-item), night waking (3-item), sleep duration (3-item), and sleep onset delay (one item). Parents reported sleep habits of their children one week ago. All items are rated on a three-point scale: rarely = 1 (0 –1 time/week); sometimes = 2 (2 – 4 times/week); and usually = 3 (5 – 7 times/week). Higher scores reflect more difficulties in sleep habits. The reliability of this questionnaire was confirmed with alpha coefficients ranging from 0.44 to 0.93, with two weeks test-retest reliability ranging from 0.62 to 0.79 for the various subscales. Arabic version of the CSHQ was used in a prior study in our community. Cronbach’s alphas using data from Egyptian children were 0.77 for the entire scale, and 0.50 to 0.73 for subscales (Abou-Khadra, 2009). 3 to 6 monthes
Secondary Outcome The third tool is The Paediatric Quality of Life Inventory (PedsQL, Mapi Research Trust company, France, distributes the PedsQLTM internationally which developed to quantify QoL of children and adolescents aged 2-18 years (Varni, Seid, & Kurtin, 2001). It is composed of equivalent child self-report and parent proxy-report forms obtainable in numerous international languages including Arabic. The items for each of the forms are essentially identical, differing in developmentally appropriate language. The PedsQL 4.0 generic core scales − Arabic Egypt, consisted of 23 questions and evaluated how frequently of a trouble the child has had over the past month encompassing 8 items for physical functioning and 15 items for psychosocial functioning (emotional, social, and school functioning). Mean of each subscale was computed as the sum of the items divided by the number of items answered. Interpretation of the scale reveals the mean performance as total scale score (TSS). Child performance was scored on 0-4 scale. The responses for each item are reverse recorded and linearly converted into a 0-100 scale as follows: 0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0. The scale score for each dimension and TSS were calculated with higher results reflecting better QoL. Cronbach's alphas internal consistency values for the total and subscale scores of the Arabic version exceeded 0.70. Test-retest reliability was high (reliability coefficient exceeded 0.9) (El-Beh, Eddin Khalifa, Hassaan, & Noomani, 2018). 3 to 6 monthes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of nursing mansoura university El Gomhoria Street - Mansoura City Mansoura 30016 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Hashem ElMonshed El Gomhoria Street - Mansoura Mansoura 30016 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Hashem El Gomhoria Street - Mansoura Mansoura 30016 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Ahmed Loutfy 19 Hoda Abd Alasam, AlSalam Cairo 11788 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Hashem El Monshed ahmed_elmonshed@mans.edu.eg +201009976771 El Gomhoria Street - Mansoura
City Postal code Country Position/Affiliation
Mansoura 30016 Egypt Lecturer of Psychiatric and Mental Health Nursing Faculty of Nursing Mansoura University Egypt
Role Name Email Phone Street address
Public Enquiries Ahmed Loutfy ahmed.loutfy@nursing.bsu.edu.eg +201097358864 19 Hoda Abd Alasalam, AlSalam
City Postal code Country Position/Affiliation
Cairo 11788 Egypt Lecturer of Pediatric Nursing Faculty of Nursing Beni Suef University Egypt
Role Name Email Phone Street address
Scientific Enquiries Mohamed Zoromba zromba2010@gmail.com +201008388226 Al Thalatheeny Street
City Postal code Country Position/Affiliation
Port Said 42511 Egypt Lecturer of Psychiatric and Mental Health Nursing Faculty of Nursing Mansoura University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study approval at April 2022, I will upload Results Reporting for IPD immediatley after data collection. Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. controled access.““Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP). For more information or to submit a request, please contact ahmed_elmonshed@mans.edu.eg
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information