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NCT Number: NCT06350292

SLEEP-COPE: Sleep Intervention for Oppositional Children

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.

Recruiting

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida

Tampa, Florida, 33620-8100, United States

Location status: Recruiting

Location contact

Melanie Stearns, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

SLEEP: COPE

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Child Actigraphy

    Time frame: 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks

    Physiological measure of sleep efficiency, sleep onset latency, and total sleep time.

  2. Parent Actigraphy

    Time frame: 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks

    Physiological measure of sleep efficiency, sleep onset latency, and total sleep time.

  3. Child Salivary Cortisol

    Time frame: before and after a cold-pressor task at 0 weeks, 6 weeks, 10 weeks

    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.

  4. Child Hair Cortisol

    Time frame: 0 weeks, 6 weeks, 10 weeks

    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).

  5. The Revised Childhood Anxiety and Depression Scale

    Time frame: 0 weeks, 6 weeks, 10 weeks

    Measures child anxiety and depression

  6. PROMIS Child Sleep Disturbance

    Time frame: 0 weeks, 6 weeks, 10 weeks

    Measures child sleep

  7. Alabama Parenting Questionnaire

    Time frame: 0 weeks, 6 weeks, 10 weeks

    Measures parenting behaviors

  8. Perceived Stress Scale

    Time frame: 0 weeks, 6 weeks, 10 weeks

    Measures parent stress

  9. Child Disruptive Behavior Disorders Checklist

    Time frame: 0 weeks, 6 weeks, 10 weeks

    Measures child disruptive behaviors

  10. Beck Depression Inventory-II

    Time frame: 0 weeks, 6 weeks, 10 weeks

    Measures parent depression

  11. State-Trait Anxiety Inventory

    Time frame: 0 weeks, 6 weeks, 10 weeks

    Measures parent anxiety

  12. PROMIS Adult Sleep Disturbance

    Time frame: 0 weeks, 6 weeks, 10 weeks

    Measures parent sleep

  13. Pediatric Sleep Questionnaire

    Time frame: 0 weeks, 6 weeks, 10 weeks

    Measures child sleep apnea risk

  14. Epworth Sleepiness Scale

    Time frame: 0 weeks, 6 weeks, 10 weeks

    Measures parent sleep apnea risk

Study contacts

Contact information is provided by the study sponsor or research team.

Melanie A Stearns, PhD

CONTACT

[email protected]

8139748110

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 5, 2024
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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