Sleep Intervention for Oppositional Defiant Disorder

Overseen By Melanie A 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)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, children on psychotropic or other medications that alter sleep, except for stimulants, sleep medications, and melatonin, are excluded from participating.

Will I have to stop taking my current medications?

The trial does not require children to stop taking their current medications, except for those that alter sleep, unless they are stimulants, sleep medications, or melatonin.

What data supports the idea that Sleep Intervention for Oppositional Defiant Disorder is an effective treatment?

The available research shows that children with Oppositional Defiant Disorder (ODD) report more sleep problems compared to their peers. While specific data on Sleep Intervention for ODD is not provided, a study on cognitive-behavioral therapy (CBT) for sleep issues in children shows significant improvements in sleep quality and anxiety reduction. This suggests that similar approaches could be effective for children with ODD. Additionally, behavioral management of sleep problems in children has an 84% success rate, indicating that non-drug treatments can be effective for improving sleep-related issues. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment SLEEP: COPE, SLEEP-COPE, Cognitive Behavioral Treatment for Insomnia (CBT-I) for Children with Oppositional Defiant Disorder?

Research shows that cognitive-behavioral therapy (CBT) can significantly improve sleep problems in children, including those with behavioral insomnia, by reducing sleep onset time and anxiety. Additionally, behavioral management techniques have shown an 84% success rate in treating sleep disorders in children, suggesting that similar approaches could be effective for children with Oppositional Defiant Disorder. ^{1 2 3 4 5}

What safety data exists for sleep interventions in children with Oppositional Defiant Disorder?

The research indicates that Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered a safe and effective treatment for insomnia in both adults and children. While specific safety data for children with Oppositional Defiant Disorder is not directly mentioned, CBT-I is generally recognized as a safe alternative to sleeping medications, which carry more risks. The studies reviewed suggest that CBT-I, including its online adaptations, is a well-supported treatment for insomnia without significant safety concerns. ^{3 6 7 8 9}

Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for children and adults?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered safe for both children and adults, as it provides effective insomnia care without the risks associated with sleeping medications. ^{3 6 7 8 9}

Is the treatment SLEEP: COPE a promising treatment for children with Oppositional Defiant Disorder?

Yes, SLEEP: COPE is a promising treatment. It uses Cognitive Behavioral Therapy (CBT), which has been shown to improve sleep problems in children. This treatment can help children fall asleep faster, stay asleep longer, and reduce anxiety related to sleep. These improvements can benefit both the children and their families. ^{2 4 6 10 11}

How is the SLEEP: COPE treatment different from other treatments for Oppositional Defiant Disorder?

SLEEP: COPE is unique because it combines cognitive behavioral therapy (CBT) techniques specifically for treating insomnia in children with Oppositional Defiant Disorder, focusing on improving sleep patterns and reducing anxiety, which are not typically addressed in standard treatments for this condition. ^{2 4 6 10 11}

Eligibility Criteria

This trial is for children aged 8-12 with Oppositional Defiant Disorder (ODD) and chronic insomnia. They must have had sleep difficulties for over three months, affecting their mood or daily functioning. Both child and parent need to speak English. Children who don't meet the specific sleep problem criteria or have other conditions that could interfere are not eligible.

Inclusion Criteria

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

Both my child and I are proficient in English.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telehealth CBT-I sessions targeting sleep and behavioral issues in children with ODD

10 weeks

Telehealth sessions throughout the treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SLEEP: COPE

Trial Overview SLEEP-COPE is being tested in this trial; it's a telehealth Cognitive Behavioral Treatment for Insomnia (CBT-I) designed specifically for kids with ODD and their parents. The treatment aims to improve sleep issues through online sessions, making it accessible even in areas with limited mental health services.

Participant Groups

Group I: SLEEP: COPE 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

Children with Conduct Disorder/Oppositional Defiant Disorder (CD/ODD) reported significantly more sleep problems compared to normative children, indicating a potential link between sleep issues and behavioral disorders.

The study found that children with CD/ODD and comorbid ADHD slept less than those with CD/ODD alone, and poor sleep was associated with increased externalizing behavioral symptoms, suggesting that improving sleep could help alleviate these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep in children with disruptive behavioral disorders. Aronen, ET., Lampenius, T., Fontell, T., et al.[2018]

The Bedtime Pass Program (BPP) significantly reduced bedtime resistance in children aged 3 to 6, as evidenced by fewer instances of leaving their rooms and calling out for parents compared to a control group.

Parents reported high satisfaction with the BPP, which effectively maintained its benefits even three months after treatment, making it a socially acceptable and effective approach to managing bedtime issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief report: evaluating the Bedtime Pass Program for child resistance to bedtime--a randomized, controlled trial. Moore, BA., Friman, PC., Fruzzetti, AE., et al.[2015]

Chronic insomnia affects a significant portion of the population, with nearly 16% of adults and up to 25% of children experiencing it, yet many clinicians are not familiar with effective psychological treatments.

The most supported psychological treatments for adults include stimulus control, progressive muscle relaxation, and cognitive-behavioral therapy, while for children, effective methods include preventive parent education and various extinction techniques, providing a solid foundation for practitioners to help their patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of insomnia in adults and children: a practice-friendly review of research. Taylor, DJ., Roane, BM.[2010]

A controlled study involving 42 children with Behavioural Insomnia of Childhood showed that cognitive-behavioral therapy (CBT) significantly improved sleep latency, wake after sleep onset, and sleep efficiency compared to a waitlist control group.

CBT also reduced problematic sleep associations and child-reported anxiety, with these improvements maintained for at least 6 months after treatment, highlighting its effectiveness in addressing both sleep and anxiety issues in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of cognitive-behaviour therapy for behavioural insomnia of childhood in school-aged children. Paine, S., Gradisar, M.[2018]

A study of 19 children with sleep disorders showed an impressive 84% success rate using behavioral management techniques, which was sustained at a 6-month follow-up.

Successful treatment outcomes were linked to factors such as the absence of marital discord and the involvement of both parents in the treatment sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural management of sleep problems. Jones, DP., Verduyn, CM.[2019]

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]

Cognitive behavioral therapy for insomnia (CBT-I) is a safe and effective alternative to sleeping medications, but many patients are unaware or reluctant to engage with it, preferring sedative hypnotics instead.

Focus groups with 29 Veterans revealed that patients prefer a stepped-care approach to CBT-I, starting with self-management tools and progressing to provider-delivered therapy if necessary, highlighting the need for multiple outreach efforts and delivery options to increase engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). Koffel, E., Branson, M., Amundson, E., et al.[2021]

A pilot study involving 50 adolescents in Southern Nigeria demonstrated that a 5-week Cognitive Behavioural Therapy (CBT)-based intervention significantly reduced insomnia scores and improved sleep outcomes compared to a control group.

Participants in the intervention group experienced shorter sleep onset latency, longer total sleep duration, and lower depressive symptoms, indicating that CBT can be an effective treatment for insomnia in adolescents in this region.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled trial of Cognitive Behavioural Therapy-based strategies for insomnia among in-school adolescents in southern Nigeria. Egbegi, DR., Bella-Awusah, T., Omigbodun, O., et al.[2021]

A novel unguided internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) program significantly reduced insomnia symptoms by a large effect size (g = 1.11) among 317 participants, with 65% of those with severe insomnia achieving remission after treatment.

Participants also experienced moderate reductions in psychological distress (g = 0.55) and small improvements in wellbeing (g = 0.37), highlighting the program's effectiveness in a naturalistic setting without the need for guided support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-guided online cognitive behavioural therapy for insomnia: A naturalistic evaluation in patients with potential psychiatric comorbidities. Grierson, AB., Hobbs, MJ., Mason, EC.[2021]

Chronic sleep disruption in children and adolescents negatively impacts cognitive functioning, highlighting the importance of addressing sleep issues early.

Behavioral interventions, such as graduated extinction and positive bedtime routines, have been shown to significantly improve sleep problems in young children, making them effective nonpharmacological treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment and treatment of common pediatric sleep disorders. Moturi, S., Avis, K.[2021]

Online Cognitive Behavior Therapy for Insomnia (CBTI) significantly improved sleep efficiency and reduced insomnia symptoms in adolescents, with most participants reaching subclinical levels of insomnia after treatment.

The treatment also positively impacted cognitive functioning, particularly in areas like visuospatial processing and phonological working memory, suggesting that better sleep can enhance cognitive abilities in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential effects of online insomnia treatment on executive functions in adolescents. de Bruin, EJ., Dewald-Kaufmann, JF., Oort, FJ., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Sleep in children with disruptive behavioral disorders. [2018]

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

Brief report: evaluating the Bedtime Pass Program for child resistance to bedtime--a randomized, controlled trial. [2015]

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

Treatment of insomnia in adults and children: a practice-friendly review of research. [2010]

4. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of cognitive-behaviour therapy for behavioural insomnia of childhood in school-aged children. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Behavioural management of sleep problems. [2019]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). [2021]

8. England pubmed.ncbi.nlm.nih.gov

A controlled trial of Cognitive Behavioural Therapy-based strategies for insomnia among in-school adolescents in southern Nigeria. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Self-guided online cognitive behavioural therapy for insomnia: A naturalistic evaluation in patients with potential psychiatric comorbidities. [2021]

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

Assessment and treatment of common pediatric sleep disorders. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Differential effects of online insomnia treatment on executive functions in adolescents. [2018]