Web-based intervention to improve sleep in children with behavioral issues and their parents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This intervention focuses on a brief web-based cognitive behavioral treatment for insomnia (CBT-I) tailored for children aged 8-17 diagnosed with oppositional defiant disorder (ODD) and their parents. The program is designed to be iteratively adapted and tested for its acceptability, feasibility, and preliminary efficacy in addressing sleep issues. Participants will engage in a structured treatment approach that aims to improve sleep patterns and overall family dynamics. The study will assess the impact of the intervention on both the child and parent experiences related to sleep disturbances.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Child ages 8-17 with ODD (prior diagnosis) and insomnia
2. Child and parent English proficiency.

Insomnia:

1. complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
2. daytime dysfunction (mood, cognitive, social, academic) due to insomnia
3. 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:

1. Parent unable to provide informed consent or child unable to provide assent
2. Family unwilling to accept random assignment
3. Child/parent participation in another randomized research project
4. Parent unable to complete forms or implement treatment procedures due to cognitive impairment
5. Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias)
6. Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin
7. Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial
8. Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
9. Other conditions adversely affecting trial participation

Where it's running

• University of South Florida
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: Melanie Stearns, PhD
• Email: mstearns@usf.edu
• Phone: 8123828872

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Telehealth sleep intervention for children with oppositional defiant disorder

  This study tests a new online sleep program for children with Oppositional Defiant Disorder and insomnia to see if it can help them sleep better and feel more focused during the day.

  Recruiting University of South Florida · Tampa, Florida · NCT06350292

• Augmenting Parent Management Training with a Smartphone Tool

  This study tests whether adding a smartphone app to parent management training helps reduce irritability and temper outbursts in kids aged 8–13 with disruptive behavior disorders.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07764536

• Therapy approaches for irritability in youths: active treatments vs nonactive psychoeducation

  This study tests whether active psychotherapies for irritability in kids aged 8–16.5 years work better than nonactive, time-matched psychoeducation for children and their parents.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07640802

• ACTsocially: Using Acceptance and Commitment Therapy to help teens with social anxiety and oppositional behavior

  This project will test whether a transdiagnostic Acceptance and Commitment Therapy (ACT) program can reduce social anxiety and oppositional defiant behaviors in adolescents who have both conditions.

  Recruiting University of Coimbra · Coimbra · NCT07456631

• APSTZD for Insomnia: Safety and Effectiveness in Adults

  This trial tests APSTZD against an active drug and placebo to see if it helps adults with insomnia.

  Recruiting Phase 2 Apsen Farmaceutica S.A. · Bragança Paulista, São Paulo · NCT07420816

• Culturally adapted sleep education for older Korean immigrants

  This pilot tests a Korean-language, culturally adapted CBT-I sleep education program to see if it improves sleep for older Korean immigrants with chronic insomnia.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07387406

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.