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?

This trial aims to assist parents of preschoolers showing early ADHD signs by comparing two types of behavioral interventions. One group will receive standard parent training, while the other will focus on improving the child's sleep through a Sleep-Focused Parent Behavioral Intervention. The researchers will determine if the sleep-focused approach can better manage both sleep issues and ADHD symptoms. Families with children aged 3-5 who exhibit four or more ADHD symptoms and sleep problems may be eligible to participate. As an unphased trial, this study offers families the chance to explore innovative behavioral interventions that could enhance their child's sleep and ADHD symptoms.

Will I have to stop taking my current medications?

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

What prior data suggests that these interventions are safe for preschoolers with ADHD?

Earlier studies have shown that the Brief Parent Behavioral Intervention (BPI) is safe for children with ADHD. Research indicates it can improve problem behaviors without major side effects. Parents in these studies reported feeling more confident in managing ADHD symptoms.

For the Sleep-Focused Parent Behavioral Intervention (SF-PBI), research suggests it is generally safe for children. Studies show that sleep interventions like SF-PBI can enhance sleep and quality of life for kids at risk of ADHD. Trials with similar sleep-focused methods have reported no significant negative effects.

Both interventions have been tested and are considered safe options for young children with ADHD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer targeted approaches to managing ADHD in preschoolers by addressing sleep-related issues. Unlike standard treatments for ADHD, which often include medication and general behavioral interventions, the Sleep-Focused Parent Behavioral Intervention specifically targets behaviors that disrupt sleep. This focus on sleep is crucial because improving sleep may enhance overall ADHD symptom management, offering a more holistic approach to treatment. The Brief Parent Behavioral Intervention, while not specifically sleep-focused, provides evidence-based strategies to help parents manage ADHD symptoms effectively, which could also indirectly improve sleep and overall behavior.

What evidence suggests that these interventions could be effective for preschoolers with ADHD?

Research has shown that short training programs for parents can effectively reduce ADHD symptoms in young children. One study reported significant improvements in symptoms of ADHD and oppositional defiant disorder, with only 14.2% of participants dropping out. In this trial, participants will join one of two programs. The Brief Parent Behavioral Intervention helps parents manage ADHD symptoms. Meanwhile, the Sleep-Focused Parent Behavioral Intervention specifically targets sleep problems in children with ADHD. Studies indicate that addressing these sleep issues can improve both sleep and overall quality of life. Another study found that tackling sleep issues early leads to better outcomes for children with ADHD. ^{3 6 7 8 9}

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

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]

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]

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 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]

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]

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 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]

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 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]

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