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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist children with Oppositional Defiant Disorder (ODD) who experience insomnia. It tests a telehealth cognitive behavioral treatment for insomnia (CBT-I) called SLEEP: COPE, which includes techniques like sleep hygiene and behavioral strategies involving both the child and their parents. The trial targets children aged 8-12 diagnosed with ODD who have ongoing sleep issues, such as difficulty falling or staying asleep, impacting their daily life for over three months. Telehealth delivery facilitates participation for families in areas with limited mental healthcare access. As an unphased trial, this study provides families the opportunity to access innovative treatment strategies that could enhance their child's sleep and overall well-being.

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 prior data suggests that this telehealth CBT-I method is safe for children with ODD?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is a safe and effective treatment for insomnia in both adults and children. This includes the online version used in the SLEEP: COPE program. The therapy employs techniques such as sleep hygiene (practicing good sleep habits) and sleep restriction (spending less time in bed to improve sleep quality), which have been well-received by other groups.

Although SLEEP: COPE has not been specifically tested in children with Oppositional Defiant Disorder (ODD), the main CBT-I methods have a strong safety record in similar situations. Studies have not identified any serious side effects from these techniques in other groups. This suggests that the treatment is likely safe for children with ODD, although specific testing for this group continues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for Oppositional Defiant Disorder (ODD), which often involves behavioral therapy and medication, SLEEP: COPE is unique because it integrates cognitive behavioral therapy for insomnia (CBT-I) specifically tailored for children with ODD and their parents. It combines traditional sleep hygiene practices with techniques designed to engage both children and parents, focusing on collaborative behavioral strategies. Researchers are excited about this approach because it addresses sleep issues, which are common in children with ODD, potentially improving both sleep and behavioral symptoms simultaneously.

What evidence suggests that SLEEP-COPE might be an effective treatment for Oppositional Defiant Disorder?

Studies have shown that cognitive behavioral therapy for insomnia (CBT-I) greatly improves sleep and reduces insomnia symptoms in teenagers. Research also shows that delivering CBT-I through telehealth works well for both adults and children, making it a good option for those who can't easily attend in-person sessions. This trial will evaluate the SLEEP: COPE program, which incorporates CBT-I techniques specifically for children with Oppositional Defiant Disorder (ODD). Early findings suggest that CBT-I can help with insomnia and related issues like mood problems and rule-breaking, which are common in children with ODD. Telehealth CBT-I is especially helpful for reaching children with ODD because it can involve parents in using behavioral strategies, enhancing the treatment's effectiveness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

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

Both my child and I are proficient in English.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-defiant-disorder-oppositional-3-2024-198a1

Sleep Intervention for Oppositional Defiant Disorder Online Cognitive Behavior Therapy for Insomnia (CBTI) significantly improved sleep efficiency and reduced insomnia symptoms in adolescents, with most ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06350292

SLEEP-COPE: Sleep Intervention for Oppositional Children Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in- ...

3. trialstoday.org trialstoday.org/trial/NCT06350292

SLEEP-COPE: Sleep Intervention for Oppositional Children Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6826338/

The Associations Between Disruptive Behavior Problems ... Results. Oppositionality/aggression was the only disruptive behavior and attention disorder symptom associated with more sleep habit problems.

5. frontiersin.org frontiersin.org/journals/sleep/articles/10.3389/frsle.2024.1401023/full

Efficacy of a telehealth cognitive behavioral therapy for ... This study supports the efficacy of CBT-NC for improving sleep maintenance, nightmare frequency and distress, and other mental health difficulties in youth.

6. clinconnect.io clinconnect.io/trials/NCT06350292

SLEEP-COPE: Sleep Intervention for Oppositional Children The SLEEP-COPE study is researching a new way to help children aged 8 to 12 who have Oppositional Defiant Disorder (ODD) and are struggling with insomnia.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4144678/

Sleep Problems Predict and are Predicted by Generalized ... Sleep problems both predict and are predicted by a diagnostic cluster that includes oppositional defiant disorder, generalized anxiety disorder and depression.