Effectiveness of adding melatonin and sleep hygiene education to the usual treatment of attention deficit hyperactivity disorder with sleep phase delay syndrome.

Phase 3

Recruiting

• Conditions: Attention Deficit-Hyperactivity Disorder.; Attention-deficit hyperactivity disorder, combined type; F90.2

• Registration Number: IRCT20211004052670N5
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Definitive diagnosis of ADHD with DSPS between 12 and 18 years
Informed consent to participate in the research project
Having minimum education (reading and writing literacy) of parents for sleep training for teenagers

Exclusion Criteria

Suffering from chronic physical diseases including diabetes, liver problems, immune system defects and autoimmune diseases
Taking medicine with side effects of sleep problems such as insomnia or hypersomnia

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determining the mean scores of Conners Hyperactivity Questionnaire. Timepoint: The questionnaire is administered at the baseline visit (before the intervention), after participating in sleep health education sessions and taking melatonin medicine, and then three months after the intervention is completed for follow-up. Method of measurement: Conners Hyperactivity Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Sleep quality score. Timepoint: The questionnaire is administered at the baseline visit (before the intervention), after the training sessions on sleep hygiene and the use of melatonin medication, and three months after the end of the intervention for follow-up. Method of measurement: Petersburg Sleep Quality Questionnaire.