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Recruiting NCT06410495

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

No phase Interventional Oppositional Defiant Disorder Insomnia Chronic

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: NiteCAPP SINCC.
Who it may be relevant to
Registry conditions: Oppositional Defiant Disorder, Insomnia Chronic. Basic parameters: 8 years — 17 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 →

Overview

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.

Interventions

  • Behavioral NiteCAPP SINCC
    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 Heartrate Variability [Time frame: during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks]
  • Parent Heartrate Variability [Time frame: during a cold-pressor task at 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 8-17 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: NCT06410495 · 6595

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗