Sleep-Focused Parenting Intervention for Preschoolers with ADHD

(OASIS Trial)

Recruiting at 6 trial locations

Overseen By Heather M Joseph, DO

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Narcolepsy, Obstructive sleep apnea, others

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

Compensation: Varies

Number of Visits: 3

Duration: 4 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this pilot clinical effectiveness trial is to compare a brief parent behavioral intervention (PBI) to a modified sleep focused PBI (SF-PBI) delivered by therapists in pediatric primary care for families of children 3-5 years old with sleep problems and early ADHD symptoms. The main aims are to: Aim 1: Demonstrate the acceptability, feasibility, and appropriateness of the sleep focused PBI (SF-PBI) delivered in pediatric primary care for preschool-aged children (3-5 years old) at elevated risk for ADHD. Aim 2: Examine change in target engagement (sleep) and ADHD symptoms among preschool-aged children at elevated risk for ADHD receiving SF-PBI compared to standard PBI.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is the Sleep-Focused Parenting Intervention for Preschoolers with ADHD safe for humans?

The available research on behavioral sleep interventions, including those for children with ADHD, suggests they are generally safe for humans. These interventions have been studied for their effects on sleep and related issues, with no significant safety concerns reported. ^{1 2 3 4 5}

How is the Sleep-Focused Parenting Intervention for preschoolers with ADHD different from other treatments?

This treatment is unique because it specifically targets sleep problems in preschoolers with ADHD through a parent-focused behavioral approach, which not only improves sleep but also reduces anxiety and behavioral issues, unlike other treatments that may not address sleep directly. ^{2 3 6 7 8}

What data supports the effectiveness of the treatment Sleep-Focused Parenting Intervention for Preschoolers with ADHD?

Research shows that brief behavioral sleep interventions can effectively improve sleep problems in children with ADHD. Additionally, a study found that a group-based, parent-focused behavioral intervention significantly improved sleep, anxiety, and behavior problems in preschool children, with some benefits maintained over time. ^{2 3 4 9 10}

Who Is on the Research Team?

Heather M Joseph, DO

Principal Investigator

Assistant Professor of Psychiatry and Pediatrics, University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for English-speaking children aged 3-5 who show signs of ADHD and sleep problems, as reported by their legal guardians. Guardians must be at least 18 years old. Children with severe neurodevelopmental disorders or sleep issues due to medical conditions like narcolepsy or obstructive sleep apnea cannot participate.

Inclusion Criteria

My child is between 3 and 5 years old.

The person taking care of you has noticed that you have at least 4 symptoms of ADHD.

I am between 3 and 5 years old.

Exclusion Criteria

I have a medical condition like narcolepsy or sleep apnea that affects my sleep.

You have a serious developmental disorder related to the nervous system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a brief parent behavioral intervention or a sleep-focused parent behavioral intervention delivered by therapists in pediatric primary care

4 months

Regular visits with therapists in pediatric primary care

Follow-up

Participants are monitored for changes in sleep and ADHD symptoms, including actigraphy and sleep diary data collection

4 months

3 timepoints for data collection

What Are the Treatments Tested in This Trial?

Interventions

• Brief Parent Behavioral Intervention
• Sleep-Focused Parent Behavioral Intervention

Trial Overview The study compares two parenting interventions: a brief behavioral one and a modified version focused on improving the child's sleep (SF-PBI). It aims to see which is more acceptable, feasible, appropriate, and effective in reducing ADHD symptoms and improving sleep among preschoolers.

How Is the Trial Designed?

Group I: Sleep-Focused Parent Behavioral Intervention Experimental Treatment 1 Intervention

A modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors.

Group II: Brief Parent Behavioral Intervention Active Control 1 Intervention

A brief parent behavioral intervention with evidenced based strategies for treatment of ADHD.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A brief behavioral sleep intervention significantly improved clinicians' confidence and competence in managing sleep issues in children with ADHD, as reported by 59 trained clinicians.

Parents who reported higher use of sleep strategies from the program saw improvements in their children's sleep problems at 3 and 6 months, indicating the program's effectiveness from a family perspective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief clinician training program to manage sleep problems in ADHD: what works and what do clinicians and parents think? Sciberras, E., Mulraney, M., Hayes, N., et al.[2022]

A parent-focused behavioral intervention (BI) significantly improved sleep, anxiety, and behavioral problems in preschool children compared to usual care, with 62 parents in the BI group and 66 in the control group.

Improvements in sleep were linked to reductions in anxiety and behavioral symptoms, indicating that addressing sleep issues can positively impact overall child well-being, although the intervention did not affect school transition or academic performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating sleep problems in young children: A randomised controlled trial of a group-based, parent-focused behavioural sleep intervention. Donovan, CL., Shiels, A., Legg, M., et al.[2023]

A study involving 2090 parents of infants aged 3-18 months found that Unmodified and Modified Extinction sleep interventions led to longer and more consolidated sleep for infants compared to Parental Presence and non-intervention groups.

Despite being perceived as more difficult to implement, Unmodified and Modified Extinction were also rated as more helpful and quicker to show improvements, with no negative impacts on parent sleep, daytime sleepiness, depression, or parent-infant bonding, indicating their safety and effectiveness in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Behavioral Interventions for Infant Sleep Problems in Real-World Settings. Kahn, M., Barnett, N., Gradisar, M.[2023]

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 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]

A survey of 652 parents using behavioral sleep intervention (BSI) showed that most successfully implemented the method, with 83% reporting success on their first attempt, typically completing the process within 2 weeks.

Infants experienced significantly reduced crying time after one week of BSI, dropping from an average of 43 minutes on the first night to about 8.5 minutes, and parents noted improvements in their infants' sleep patterns, including fewer awakenings and better ability to fall asleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Implementation of Infant Behavioral Sleep Interventions: Results of a Parental Survey. Honaker, SM., Schwichtenberg, AJ., Kreps, TA., et al.[2019]

The Safe Start Study is a randomized controlled trial designed to evaluate the effectiveness of a safe sleep education intervention for parents during well child visits, involving mother-baby dyads from a large urban pediatric practice.

The study aims to improve infant sleep safety by measuring changes in parents' knowledge and behaviors regarding safe sleep practices, with primary outcomes including self-reported behaviors and observations of the sleep environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health education intervention promoting infant safe sleep in paediatric primary care: randomised controlled trial. McDonald, EM., Davani, A., Price, A., et al.[2021]

The Sleeping Sound with ADHD trial is a randomized controlled trial involving 198 children aged 5 to 12 years, aiming to evaluate the effectiveness of a behavioral sleep program for treating sleep problems in children with ADHD.

If successful, this non-pharmacological intervention could significantly improve sleep quality and reduce ADHD symptoms, offering a feasible and acceptable treatment option for affected children and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: the sleeping sound with attention-deficit/hyperactivity disorder project. Sciberras, E., Efron, D., Gerner, B., et al.[2021]

The New Forest Parenting Package (NFPP) showed improvements in ADHD and oppositional behavior as reported by parents, but these improvements were not confirmed by teacher ratings or objective measures, indicating a potential bias in parent-reported outcomes.

NFPP was not significantly more effective than the established 'Helping the Noncompliant Child' (HNC) intervention, and in some cases, it was less effective, suggesting that NFPP may not adequately address the underlying issues of ADHD in preschoolers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent training for preschool ADHD: a randomized controlled trial of specialized and generic programs. Abikoff, HB., Thompson, M., Laver-Bradbury, C., et al.[2021]

The New Forest Parenting Programme (NFPP) is being tested as a first-line treatment for preschool ADHD in a multicenter trial involving 140 children aged 3-7, comparing its effectiveness to standard treatment.

The trial will assess changes in ADHD symptoms using the Preschool ADHD-Rating Scale at multiple time points, aiming to provide evidence on whether NFPP is more effective than usual care in everyday clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Parent Training as a Treatment for Preschool Attention-Deficit/Hyperactivity Disorder: Study Protocol for a Randomized Controlled, Multicenter Trial of the New Forest Parenting Program in Everyday Clinical Practice. Lange, AM., Daley, D., Frydenberg, M., et al.[2023]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

A brief clinician training program to manage sleep problems in ADHD: what works and what do clinicians and parents think? [2022]

2. England pubmed.ncbi.nlm.nih.gov

Treating sleep problems in young children: A randomised controlled trial of a group-based, parent-focused behavioural sleep intervention. [2023]

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

Implementation of Behavioral Interventions for Infant Sleep Problems in Real-World Settings. [2023]

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

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

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

Behavioural management of sleep problems. [2019]

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

Real-World Implementation of Infant Behavioral Sleep Interventions: Results of a Parental Survey. [2019]

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

Health education intervention promoting infant safe sleep in paediatric primary care: randomised controlled trial. [2021]

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

Study protocol: the sleeping sound with attention-deficit/hyperactivity disorder project. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Parent training for preschool ADHD: a randomized controlled trial of specialized and generic programs. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

The Effectiveness of Parent Training as a Treatment for Preschool Attention-Deficit/Hyperactivity Disorder: Study Protocol for a Randomized Controlled, Multicenter Trial of the New Forest Parenting Program in Everyday Clinical Practice. [2023]