Digital Therapy for Children With ODD and Sleep Issues

Overseen By Melanie Stearns, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Must not be taking: Psychotropics, others

Disqualifiers: Apnea, Epilepsy, Psychotic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow children to continue using stimulants, sleep medications, and melatonin.

What data supports the effectiveness of the treatment NiteCAPP SINCC, NiteCAPP CARES, NiteCAPP SHARES, NiteCAPP SINCC for children with ODD and sleep issues?

Research on similar treatments, like the CBT-I Coach app for insomnia, shows that digital cognitive-behavioral therapy can improve sleep by increasing patient engagement and compliance with therapy. Additionally, the Better Nights, Better Days program, an online intervention for children with insomnia, was found helpful by parents and healthcare providers, suggesting that digital therapies can be effective for sleep issues in children. ^{1 2 3 4 5}

Is the digital therapy for children with ODD and sleep issues safe?

The digital therapy, which includes cognitive-behavioral therapy (CBT) approaches for insomnia, has been tested in children with sleep problems and shown to improve sleep behaviors without reported safety concerns. A pilot study using a mobile app for delivering CBT-focused sleep solutions showed positive results in improving sleep in children, suggesting it is generally safe. ^{1 2 3 6 7}

How is the NiteCAPP SINCC treatment different from other treatments for children with ODD and sleep issues?

NiteCAPP SINCC is unique because it is a digital therapy that likely incorporates cognitive behavioral therapy (CBT) strategies, which are delivered online to improve sleep issues in children. This approach is novel as it provides accessible, evidence-based sleep solutions through digital means, potentially reducing barriers to treatment access for children with ODD and sleep problems. ^{1 7 8 9 10}

Eligibility Criteria

This trial is for children aged 8-12 with Oppositional Defiant Disorder (ODD) and chronic insomnia, lasting over 3 months. Both child and parent must speak English. Kids on certain medications or undergoing other sleep treatments, or those with untreated medical issues like psychotic disorders are excluded.

Inclusion Criteria

My child or I have had trouble sleeping for over 3 months.

Child and parent must have English proficiency

My child, aged 8-12, has been diagnosed with ODD and suffers from insomnia.

Exclusion Criteria

My child is not in any other sleep treatment studies.

My family and I are not open to being randomly assigned in the trial.

Child/parent participation in another randomized research project

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a brief web-based cognitive behavioral treatment for insomnia (CBT-I) for children with oppositional defiant disorder (ODD) and their parents, including sleep hygiene, stimulus control, sleep restriction, and cognitive therapy.

10 weeks

Web-based sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 0, 6, and 10 weeks.

4 weeks

Treatment Details

Interventions

• NiteCAPP SINCC

Trial Overview The NiteCAPP SINCC program, a web-based cognitive behavioral therapy for insomnia tailored to kids with ODD and their parents, is being tested for its usability and initial effectiveness in improving sleep patterns.

Participant Groups

Group I: NiteCAPP SINCC Experimental Treatment 1 Intervention

Content includes both standard CBT-I techniques \[sleep hygiene, stimulus control, sleep restriction, cognitive therapy\] as well as those targeting children with ODD and their parents. Active child participation is a goal but may be limited due to age/abilities. Parents will work with children to implement behavioral strategies.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Findings from Research

In a study involving 13 children aged 3 to 14 years, nCPAP/nBIPAP therapy showed positive effects on behavior, school performance, and frequency of upper airway infections.

The therapy also improved sleep parameters, including sleep structure, number of apneas, oxygen saturation, and mean heart rate, indicating its efficacy in treating sleep-related disturbances in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[nCPAP/nBIPAP therapy in sleep-related obstructive respiratory disorders in childhood]. Scholle, S., Zwacka, G., Glaser, S., et al.[2013]

The Better Nights, Better Days (BNBD) program, an online intervention for treating insomnia in children aged 1-10, was tailored to address insomnia symptoms that persist after surgical treatment for obstructive sleep apnea (OSA).

Usability testing with 43 participants, including parents and healthcare providers, indicated that the new session was generally viewed as helpful, suggesting that further testing on a larger scale could enhance its effectiveness for children experiencing insomnia post-OSA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A usability study of an internet-delivered behavioural intervention tailored for children with residual insomnia symptoms after obstructive sleep apnea treatment. Orr, M., Isaacs, J., Godbout, R., et al.[2023]

A survey of 108 Veterans Affairs-trained clinicians revealed that 50% used the CBT-I Coach app for cognitive-behavioral therapy for insomnia, with 98% of users intending to continue its use, indicating strong acceptance and perceived utility in enhancing patient engagement and compliance.

Clinicians who used the app found it less complex and more compatible with their practice compared to nonusers, although barriers such as patient access to smartphones and lack of awareness hindered broader adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician Perceptions Related to the Use of the CBT-I Coach Mobile App. Miller, KE., Kuhn, E., Owen, JE., et al.[2022]

Computerized cognitive behavioral therapy for insomnia (CCBT-I) has been shown to significantly improve various sleep-related outcomes, such as sleep quality and sleep efficiency, based on a meta-analysis of 6 randomized controlled trials involving 533 papers.

With a high treatment adherence rate of 78% and a moderate effect size, CCBT-I is considered a viable low-intensity self-help therapy for insomnia, making it a useful option in stepped care models for treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised cognitive behavioural therapy for insomnia: a systematic review and meta-analysis. Cheng, SK., Dizon, J.[2022]

Before the release of the CBT-I Coach app, 87% of VA-trained clinicians believed it could improve insomnia treatment and intended to use it, indicating strong initial support for the app's potential benefits.

Two years post-release, nearly 60% of clinicians reported using the app with patients, noting positive effects on homework adherence and treatment outcomes, suggesting that the app effectively supports cognitive behavioral therapy for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CBT-I Coach: A Description and Clinician Perceptions of a Mobile App for Cognitive Behavioral Therapy for Insomnia. Kuhn, E., Weiss, BJ., Taylor, KL., et al.[2018]

The study will evaluate the effectiveness of Internet-delivered cognitive-behavioral therapy for insomnia (CBT-I) in 180 adolescents aged 11-17 with migraine and insomnia, aiming to improve sleep and potentially reduce migraine severity.

This research will also explore how improvements in sleep from CBT-I may enhance the effectiveness of subsequent cognitive-behavioral therapy for pain management (CBT-Pain), addressing a significant gap in treatment for youth with these comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention for Sleep and Pain in Youth (ISPY-RCT): protocol for a two-phase randomized controlled trial of sequenced cognitive-behavioral therapy for insomnia and pain management in adolescents with migraine. Law, EF., Ritterband, L., Zhou, C., et al.[2023]

A survey of 218 families revealed a high prevalence of sleep problems in children, with 85% of children aged 5-12 experiencing difficulties, highlighting the need for effective treatment options.

In a pilot study involving 11 families, a digital intervention using CBT-focused strategies led to significant improvements in sleep behaviors, including a 75.6% reduction in time awake and an increase of over 1 hour in total sleep time, demonstrating the effectiveness of digital sleep solutions for pediatric sleep issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital solutions for sleep problems in children: A pilot study. Tedford, SE., Romano, L., Gozal, D., et al.[2022]

The online adaptation of cognitive behavioral therapy for insomnia (CBT-I) for children aged 5-10 was well accepted by parents, who found it helpful and time-saving, indicating strong parental support for this intervention.

In this pilot study with 12 parents and 6 children, 67% of the children showed reduced sleep problems after participating in the online group iCBT-I, suggesting its potential efficacy in addressing insomnia in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online cognitive behavioral group therapy (iCBT-I) for insomnia for school children and their parents: Adaptation of an established treatment (KiSS training). Schlarb, AA., Schulte, H., Selbmann, A., et al.[2022]

The Nitra application, an internet-based cognitive behavioral therapy for insomnia (CBT-i), significantly improved sleep efficiency and various sleep parameters in 40 adults with chronic subthreshold to moderate insomnia over a 4-week intervention period.

Participants who adhered closely to the recommended sleep schedule showed a higher likelihood of achieving normal sleep efficiency, highlighting the importance of consistent sleep habits in managing insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. Theppornpitak, W., Hemrungrojn, S., Thienwiwatnukul, K., et al.[2023]

A study involving 43 parents and 44 healthcare professionals revealed that both groups found an online insomnia intervention for children with neurodevelopmental disorders to be generally acceptable, highlighting its accessibility and usability as major advantages.

Despite the positive perceptions, concerns about the feasibility of implementing the intervention were raised, suggesting that additional support, like an online coach, could enhance its acceptability and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of an online intervention for insomnia in children with neurodevelopmental disorders. Tan-MacNeill, KM., Smith, IM., Corkum, PV.[2023]

References

1. Austria pubmed.ncbi.nlm.nih.gov

[nCPAP/nBIPAP therapy in sleep-related obstructive respiratory disorders in childhood]. [2013]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A usability study of an internet-delivered behavioural intervention tailored for children with residual insomnia symptoms after obstructive sleep apnea treatment. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Clinician Perceptions Related to the Use of the CBT-I Coach Mobile App. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Computerised cognitive behavioural therapy for insomnia: a systematic review and meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

CBT-I Coach: A Description and Clinician Perceptions of a Mobile App for Cognitive Behavioral Therapy for Insomnia. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Intervention for Sleep and Pain in Youth (ISPY-RCT): protocol for a two-phase randomized controlled trial of sequenced cognitive-behavioral therapy for insomnia and pain management in adolescents with migraine. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Digital solutions for sleep problems in children: A pilot study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Online cognitive behavioral group therapy (iCBT-I) for insomnia for school children and their parents: Adaptation of an established treatment (KiSS training). [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Acceptability of an online intervention for insomnia in children with neurodevelopmental disorders. [2023]