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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLEEP: COPE | Behavioral | Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Child Actigraphy | Physiological measure of sleep efficiency, sleep onset latency, and total sleep time. | 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. |
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Inclusion criteria:
Insomnia:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melanie A Stearns, PhD | Contact | 8139748110 | mstearns@usf.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Recruiting | Tampa | Florida | 33620-8100 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000096865 | Oppositional Defiant Disorder |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| 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. | 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). | 0 weeks, 6 weeks, 10 weeks |
| The Revised Childhood Anxiety and Depression Scale | Measures child anxiety and depression | 0 weeks, 6 weeks, 10 weeks |
| PROMIS Child Sleep Disturbance | Measures child sleep | 0 weeks, 6 weeks, 10 weeks |
| Alabama Parenting Questionnaire | Measures parenting behaviors | 0 weeks, 6 weeks, 10 weeks |
| Perceived Stress Scale | Measures parent stress | 0 weeks, 6 weeks, 10 weeks |
| Child Disruptive Behavior Disorders Checklist | Measures child disruptive behaviors | 0 weeks, 6 weeks, 10 weeks |
| Beck Depression Inventory-II | Measures parent depression | 0 weeks, 6 weeks, 10 weeks |
| State-Trait Anxiety Inventory | Measures parent anxiety | 0 weeks, 6 weeks, 10 weeks |
| PROMIS Adult Sleep Disturbance | Measures parent sleep | 0 weeks, 6 weeks, 10 weeks |
| Pediatric Sleep Questionnaire | Measures child sleep apnea risk | 0 weeks, 6 weeks, 10 weeks |
| Epworth Sleepiness Scale | Measures parent sleep apnea risk | 0 weeks, 6 weeks, 10 weeks |
| D001523 |
| Mental Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |