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Recruiting NCT06350292

SLEEP-COPE: Sleep Intervention for Oppositional Children

No phase Interventional Insomnia Chronic Oppositional Defiant Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SLEEP: COPE.
Who it may be relevant to
Registry conditions: Insomnia Chronic, Oppositional Defiant Disorder. Basic parameters: 8 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral SLEEP: COPE
    Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.

Primary outcome measures

  • Child Daily Sleep Diaries [Time frame: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks]
  • Parent Daily Sleep Diaries [Time frame: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of South Florida — Tampa

Identifiers

NCT: NCT06350292 · 0161464

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗