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

University of South Florida

Status: Enrolling

Conditions: Oppositional Defiant Disorder; Insomnia Chronic

Treatments: Behavioral: NiteCAPP SINCC

Study type: Interventional

Funder types: Other

Identifiers

NCT06410495

6595

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

NiteCAPP SINCC

Experimental group

Description:

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.

Treatment:

Behavioral: NiteCAPP SINCC