Behavioral Sleep Intervention and Sleep Problems among Children with Attention Deficit Hyperactivity Disorder

The Efficacy of Behavioral Sleep Intervention on Sleep Problems among Children with Attention Deficit Hyperactivity Disorder: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202205632538061

Enrollment

Registered

2022-05-18

Start date

2022-05-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental and Behavioural Disorders

Interventions

Placebo

study group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Children with documented history of seizures, neurodegenerative disease, head injury, or mental retardation will be excluded.

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Egypt

Contacts

Public ContactAhmed Loutfy

Lecturer of Pediatric Nursing Faculty of Nursing Beni Suef University Egypt

ahmed.loutfy@nursing.bsu.edu.eg+201097358864

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026