Actively Recruiting

Phase Not Applicable
Age: 8Years - 17Years
All Genders
NCT06410495

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

Led by University of South Florida · Updated on 2025-03-28

30

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 8Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child aged 8 to 17 years with a prior diagnosis of oppositional defiant disorder (ODD) and insomnia
  • Child and parent are proficient in English
  • Child has had sleep difficulties such as trouble falling asleep, staying asleep, or early awakening for at least 3 months
  • Child experiences daytime problems related to insomnia, including mood, cognitive, social, or academic difficulties
  • Sleep diaries and actigraphy show more than 30 minutes of sleep onset delay, night awakenings, or early morning awakening on at least 6 nights
Not Eligible

You will not qualify if you...

  • Parent unable to provide informed consent or child unable to provide assent
  • Family unwilling to accept random assignment
  • Child or parent currently participating in another randomized research study
  • Parent has cognitive impairment preventing completion of forms or treatment
  • Child has untreated medical conditions including other sleep disorders like apnea, epilepsy, psychotic disorders, suicidal ideation or parasomnias
  • Child uses psychotropic or other medications that affect sleep except stimulants, sleep medications, or melatonin
  • Child is receiving other non-drug sleep treatments including cognitive behavioral therapy outside this study
  • Parent cannot tolerate Holter monitoring or actigraphy due to sensitivity or behavior issues
  • Other conditions that could negatively affect participation in the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of South Florida

Tampa, Florida, United States, 33620-8100

Actively Recruiting

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Research Team

M

Melanie Stearns, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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