SLEEP-COPE: Sleep Intervention for Oppositional Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorUniversity of South Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
SLEEP: COPE
BehavioralStandard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: SLEEP: COPEExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks2
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.
Time frame
Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeksSecondary outcomes
1
Child Actigraphy
Physiological measure of sleep efficiency, sleep onset latency, and total sleep time.
Time frame
24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks2
Parent Actigraphy
Physiological measure of sleep efficiency, sleep onset latency, and total sleep time.
Time frame
24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks3
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.
Time frame
before and after a cold-pressor task at 0 weeks, 6 weeks, 10 weeks4
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).
Time frame
0 weeks, 6 weeks, 10 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov