Health TrialsbyHealthPanel

Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)

ConditionsOppositional Defiant DisorderInsomnia Chronic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorUniversity of South Florida

About this trial

In this proposal a brief web-based cognitive behavioral treatment for insomnia (CBT-I) for children with oppositional defiant disorder (ODD) and their parents is iteratively adapted and tested for acceptability, feasibility, and preliminary efficacy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Child ages 8-17 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

  • NiteCAPP SINCC

    Behavioral

    Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: NiteCAPP SINCCExperimental 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 weeks
2

Parent Daily Sleep Diaries

Daily diaries filled out by parent 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 weeks

Secondary 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 weeks
2

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 weeks
3

Child Heartrate Variability

Child heartrate variability will be measured during the following: 1) resting state, 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) resting state

Time frame
during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks
4

Parent Heartrate Variability

Parent heartrate variability will be measured during the following: 1) resting state, 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) resting state

Time frame
during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Florida

Lead sponsor

Source ClinicalTrials.gov
Apply now