Insomnia ChronicNCT06350292
SLEEP-COPE: Sleep Intervention for Oppositional Children
A study testing SLEEP: COPE in people with Insomnia Chronic and Oppositional Defiant Disorder, run by University of South Florida at 1 site in United States.
Trial summary
Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Insomnia Chronic, Oppositional Defiant Disorder
- What is being tested?
- SLEEP: COPE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child ages 8-12 with ODD (prior diagnosis) and insomnia
- Child and parent English proficiency.
- Insomnia:
- complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
- daytime dysfunction (mood, cognitive, social, academic) due to insomnia
- baseline diaries and actigraphy indicate >30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights
Who cannot join
- Parent unable to provide informed consent or child unable to provide assent
- Family unwilling to accept random assignment
- Child/parent participation in another randomized research project
- Parent unable to complete forms or implement treatment procedures due to cognitive impairment
- Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, [frequent] parasomnias)
- Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin
Show all 9Show fewer
- Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial
- Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
- Other conditions adversely affecting trial participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33620-8100
Melanie Stearns, PhD, mstearns@usf.edu
About this study
Official title: SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions
Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents.
- Conditions
- Insomnia Chronic, Oppositional Defiant Disorder
- Being tested
- SLEEP: COPE
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLEEP: COPEBehavioural
Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.
| Study group | Role | What they receive |
|---|---|---|
| SLEEP: COPE | Experimental | Content includes both standard CBT-I techniques [sleep hygiene, stimulus control, sleep restriction, cognitive therapy] as well as those targeting children with ODD and their parents. Active child participation is a goal but may be limited due to age/abilities. Parents will work with children to implement behavioral strategies. Receives: Behavioral: SLEEP: COPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Daily Sleep Diaries
Daily diaries filled out by children with parent assistance that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure child behavior.
Measured: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks
Parent Daily Sleep Diaries
Daily diaries filled out by parents that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure parenting techniques.
Measured: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks
Secondary outcomes (14)
Child Actigraphy
Physiological measure of sleep efficiency, sleep onset latency, and total sleep time.
Measured: 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
Parent Actigraphy
Physiological measure of sleep efficiency, sleep onset latency, and total sleep time.
Measured: 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
Child Salivary Cortisol
Salivary cortisol collected in the morning before and after cold-pressor task and immediately frozen. Saliva samples (25 µL) assayed in duplicate. At rest children will undergo the following: 1) baseline saliva collection, 2) cold pressor stimulation to hand (place hand to bottom of 4° Celsius ice water) for 30 secs, 3) 3 min recovery, 4) cold pressor stimulation to other hand for 30secs, 5) post assessment saliva collection.
Measured: before and after a cold-pressor task at 0 weeks, 6 weeks, 10 weeks
Child Hair Cortisol
Hair collected (15-50 mg) will be cut into 1 cm segments and ground into a fine powder before extracted with methanol for 16-18 hours while shaking. Cortisol then is quantified by liquid chromatography - tandem mass spectrometry (LC-MS/MS) (Salimetrics LLC, State College PA).
Measured: 0 weeks, 6 weeks, 10 weeks
The Revised Childhood Anxiety and Depression Scale
Measures child anxiety and depression
Measured: 0 weeks, 6 weeks, 10 weeks
PROMIS Child Sleep Disturbance
Measures child sleep
Measured: 0 weeks, 6 weeks, 10 weeks
Alabama Parenting Questionnaire
Measures parenting behaviors
Measured: 0 weeks, 6 weeks, 10 weeks
Perceived Stress Scale
Measures parent stress
Measured: 0 weeks, 6 weeks, 10 weeks
Child Disruptive Behavior Disorders Checklist
Measures child disruptive behaviors
Measured: 0 weeks, 6 weeks, 10 weeks
Beck Depression Inventory-II
Measures parent depression
Measured: 0 weeks, 6 weeks, 10 weeks
State-Trait Anxiety Inventory
Measures parent anxiety
Measured: 0 weeks, 6 weeks, 10 weeks
PROMIS Adult Sleep Disturbance
Measures parent sleep
Measured: 0 weeks, 6 weeks, 10 weeks
Pediatric Sleep Questionnaire
Measures child sleep apnea risk
Measured: 0 weeks, 6 weeks, 10 weeks
Epworth Sleepiness Scale
Measures parent sleep apnea risk
Measured: 0 weeks, 6 weeks, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melanie Stearns, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350292
- Sponsor's protocol ID
- 0161464
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions
- ClinicalTrials.gov ID
- NCT06350292
- Acronym / sponsor ID
- 0161464
- Conditions
- Insomnia Chronic, Oppositional Defiant Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 5 Apr 2024 (actual)
- 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.
Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLEEP: COPE | Experimental | Behavioral: SLEEP: COPEContent includes both standard CBT-I techniques [sleep hygiene, stimulus control, sleep restriction, cognitive therapy] as well as those targeting children with ODD and their parents. Active child participation is a goal but may be limited due to age/abilities. Parents will work with children to implement behavioral strategies. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child ages 8-12 with ODD (prior diagnosis) and insomnia
- Child and parent English proficiency.
- complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
- daytime dysfunction (mood, cognitive, social, academic) due to insomnia
- baseline diaries and actigraphy indicate >30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights
Key exclusion criteria (9 listed)
- Parent unable to provide informed consent or child unable to provide assent
- Family unwilling to accept random assignment
- Child/parent participation in another randomized research project
- Parent unable to complete forms or implement treatment procedures due to cognitive impairment
- Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, [frequent] parasomnias)
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 |
|---|---|---|
| SLEEP: COPEStandard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents. | Behavioural | SLEEP: COPE |
Primary outcome
Child Daily Sleep Diaries
Time frame: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks
Daily diaries filled out by children with parent assistance that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure child behavior.
Parent Daily Sleep Diaries
Time frame: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks
Daily diaries filled out by parents that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure parenting techniques.
14 secondary outcomes
Child Actigraphy
Time frame: 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
Parent Actigraphy
Time frame: 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
Child Salivary Cortisol
Time frame: before and after a cold-pressor task at 0 weeks, 6 weeks, 10 weeks
Child Hair Cortisol
Time frame: 0 weeks, 6 weeks, 10 weeks
The Revised Childhood Anxiety and Depression Scale
Time frame: 0 weeks, 6 weeks, 10 weeks
PROMIS Child Sleep Disturbance
Time frame: 0 weeks, 6 weeks, 10 weeks
Alabama Parenting Questionnaire
Time frame: 0 weeks, 6 weeks, 10 weeks
Perceived Stress Scale
Time frame: 0 weeks, 6 weeks, 10 weeks
Child Disruptive Behavior Disorders Checklist
Time frame: 0 weeks, 6 weeks, 10 weeks
Beck Depression Inventory-II
Time frame: 0 weeks, 6 weeks, 10 weeks
State-Trait Anxiety Inventory
Time frame: 0 weeks, 6 weeks, 10 weeks
PROMIS Adult Sleep Disturbance
Time frame: 0 weeks, 6 weeks, 10 weeks
Pediatric Sleep Questionnaire
Time frame: 0 weeks, 6 weeks, 10 weeks
Epworth Sleepiness Scale
Time frame: 0 weeks, 6 weeks, 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLEEP: COPE in people with Insomnia Chronic and Oppositional Defiant Disorder, run by University of South Florida at 1 site in United States.
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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie A Stearns, PhD (8139748110, mstearns@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Daily Sleep Diaries (time frame: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks). 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 28 Mar 2025.