Attention Deficit Hyperactivity DisordersNCT02871674
Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial
A study testing Good Night Project in people with Attention Deficit Hyperactivity Disorders and Neurodevelopmental Disorders, run by University of Leeds.
Trial summary
The study aims to implement and evaluate an RCT of behavioural sleep interventions for children aged 5-12 years with ADHD, and their primary caregivers, (women) in Saudi Arabia to address the following questions: 1. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorders, Neurodevelopmental Disorders, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Good Night Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The participants will be primary caregivers (women) of children aged 5-12 years who have been diagnosed with ADHD by a psychiatrist, using the criteria taken from Diagnostic and Statistical Manual of Mental Disorders-5 in Saudi Arabia.
- Children with comorbidities will be also included.
- Sleep difficulties are defined as a total score of over 41 in the Children's Sleep Habits Questionnaire (CSHQ).
Who cannot join
- Children will be excluded from the study if they meet any of the following criteria:
- They receive non-pharmacological interventions for their sleep difficulties.
- They have been previously diagnosed as having an intellectual disability (IQ < 70).
- They have obstructive sleep apnoea, according to the three items in the CSHQ.
About this study
The study aims to implement and evaluate an RCT of behavioural sleep interventions for children aged 5-12 years with ADHD, and their primary caregivers, (women) in Saudi Arabia to address the following questions:
- To what extent can a behavioural intervention improve sleep difficulties and increase sleep duration in children with ADHD?
- To what extent do intervention-induced changes in sleep for children or primary caregivers (women) account for any changes in ADHD symptoms?
- Conditions
- Attention Deficit Hyperactivity Disorders, Neurodevelopmental Disorders, Attention Deficit Disorder With Hyperactivity
- Being tested
- Good Night Project
- Keywords
- Behavioural interventions, Sleep difficulties, Children, Attention Deficit Hyperactivity Disorder, Randomised controlled trial, Saudi Arabia, Behavioural Insomnia
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Good Night ProjectBehavioural
The behavioural interventions have been designed on the basis of three sources. Firstly, a systematic review conducted by the research team that examined the best evidence in the field in different countries. Secondly, a Delphi study, which aimed to identify behavioural interventions that can be used to manage sleep difficulties in Saudi Arabia in accordance with professionals' views and primary caregivers' needs, and which was also conducted by the research team. Thirdly, evidence-based practice resources that help in understanding and managing sleep difficulties will be translated into Arabic.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the intervention group will receive behavioural training by psychologists in three sessions over three weeks Receives: Behavioral: Good Night Project |
| Control group - usual care | No intervention | Participants in the control group will receive usual care. They will also attend their usual appointments with the psychiatrists. They will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Children's Sleep Habits Questionnaire CSHQ
This is used widely to assess sleep, pre and post intervention, and focuses on measurement of the following subscales: Bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night waking, parasomnias, sleep-disordered breathing and daytime sleepiness. Higher scores indicate significant sleep difficulties.
Measured: 2 months
Conners' Parent Rating Scale-48 (CPRS-48)
This scale consists of 48 items that focus on five subscales: conduct problems, learning disabilities, psychosomatic disorders, impulsivity and hyperactivity and anxiety. It focuses on children aged 3-17 years.
Measured: 2 months
Secondary outcomes (3)
The Sleep Disorders Scale for primary caregivers
This scale consists of 36 items that focus on sleep difficulties in adults, and is divided according to the following subscales: insomnia, hypersomnia, circadian rhythm sleep disorders, sleep terrors and sleepwalking.
Measured: 2 months
The Depression Anxiety Stress Scales DASS
This is designed to measure negative emotions in adults, according to three subscales: depression, anxiety and stress.
Measured: 2 months
Conners' Teachers Rating Scale-28 (CTRS-28)
This scale consists of 28 items that focus on three subscales: Conduct problems, Hyperactivity, Inattentive and Passive. It focuses on children aged 3-17 years.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Shaqra University
- Responsible party
- Principal investigator, Hetaf Alammar, University of Leeds
- Investigators
- Hetaf A Alammar, PhD student, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871674
- Sponsor's protocol ID
- 0000
- Status last verified
- Jan 2017
- First submitted
- 9 Aug 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02871674
- Acronym / sponsor ID
- 0000
- Conditions
- Attention Deficit Hyperactivity Disorders, Neurodevelopmental Disorders, Attention Deficit Disorder With Hyperactivity
- Keywords
- Behavioural interventions, Sleep difficulties, Children, Attention Deficit Hyperactivity Disorder, Randomised controlled trial, Saudi Arabia, Behavioural Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Shaqra University
- Study start
- Oct 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to implement and evaluate an RCT of behavioural sleep interventions for children aged 5-12 years with ADHD, and their primary caregivers, (women) in Saudi Arabia to address the following questions:
- To what extent can a behavioural intervention improve sleep difficulties and increase sleep duration in children with ADHD?
- To what extent do intervention-induced changes in sleep for children or primary caregivers (women) account for any changes in ADHD symptoms?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Good Night ProjectParticipants in the intervention group will receive behavioural training by psychologists in three sessions over three weeks |
| Control group - usual care | No intervention | –Participants in the control group will receive usual care. They will also attend their usual appointments with the psychiatrists. They will not receive any intervention. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The participants will be primary caregivers (women) of children aged 5-12 years who have been diagnosed with ADHD by a psychiatrist, using the criteria taken from Diagnostic and Statistical Manual of Mental Disorders-5 in Saudi Arabia.
- Children with comorbidities will be also included.
- Sleep difficulties are defined as a total score of over 41 in the Children's Sleep Habits Questionnaire (CSHQ).
Key exclusion criteria (4 listed)
- They receive non-pharmacological interventions for their sleep difficulties.
- They have been previously diagnosed as having an intellectual disability (IQ < 70).
- They have obstructive sleep apnoea, according to the three items in the CSHQ.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Good Night ProjectThe behavioural interventions have been designed on the basis of three sources. Firstly, a systematic review conducted by the research team that examined the best evidence in the field in different countries. Secondly, a Delphi study, which aimed to identify behavioural interventions that can be used to manage sleep difficulties in Saudi Arabia in accordance with professionals' views and primary caregivers' needs, and which was also conducted by the research team. Thirdly, evidence-based practice resources that help in understanding and managing sleep difficulties will be translated into Arabic. | Behavioural | Intervention group |
Primary outcome
The Children's Sleep Habits Questionnaire CSHQ
Time frame: 2 months
This is used widely to assess sleep, pre and post intervention, and focuses on measurement of the following subscales: Bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night waking, parasomnias, sleep-disordered breathing and daytime sleepiness. Higher scores indicate significant sleep difficulties.
Conners' Parent Rating Scale-48 (CPRS-48)
Time frame: 2 months
This scale consists of 48 items that focus on five subscales: conduct problems, learning disabilities, psychosomatic disorders, impulsivity and hyperactivity and anxiety. It focuses on children aged 3-17 years.
3 secondary outcomes
The Sleep Disorders Scale for primary caregivers
Time frame: 2 months
The Depression Anxiety Stress Scales DASS
Time frame: 2 months
Conners' Teachers Rating Scale-28 (CTRS-28)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hetaf A Alammar, PhD student principal investigator
University of Leeds
Questions about this trial
What is this clinical trial studying?
A study testing Good Night Project in people with Attention Deficit Hyperactivity Disorders and Neurodevelopmental Disorders, run by University of Leeds.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Children's Sleep Habits Questionnaire CSHQ (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.