Treatment of Sleep Disturbances in School-age Children With Down Syndrome

NCT ID: NCT02996175

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-05-31

Brief Summary

The investigators long-term goal is to improve outcomes for children with Down syndrome (DS) and their caregivers. Towards that goal, the investigators propose a randomized clinical trial of a behavioral sleep treatment designed specifically for children with DS, documenting the impact not only on sleep, but also on the child's daytime inhibitory control and behavior problems, and the caregiver's sleep and stress levels. The investigators will randomize 80 families of children with DS ages 6-17 to receive either a 5-session behavioral sleep treatment (BST; targeting sleep education, behavioral principles and visual supports) or a general-education control condition (CON). The BST will cater to the unique needs of children with DS, adapting an intervention that successfully treats behavioral sleep disturbances in children with autism1. Pre- and post-intervention, children will undergo comprehensive assessments of cognitive, behavioral, and adaptive functioning involving direct testing and input from parents and teachers. Child and parent sleep will be monitored via actigraphy and parent-completed sleep diaries, and parents will report on their stress levels and mood.

Detailed Description

The investigators long-term goal is to improve outcomes for children with DS and their caregivers. Towards that goal, the investigators propose a randomized clinical trial of a behavioral sleep treatment designed specifically for children with DS, documenting the impact not only on sleep, but also on the child's daytime inhibitory control and behavior problems, and the caregiver's sleep and stress levels. The investigators will randomize 80 families of children with DS ages 6-17 to receive either a 5-session behavioral sleep treatment (BST; targeting sleep education, behavioral principles and visual supports) or a general-education control condition (CON). The BST will catered to the unique needs of children with DS, adapting an intervention developed by a member of the investigators research team with NIH support (R34 MH082882) that successfully treats behavioral sleep disturbances in children with autism41. Pre- and post-intervention, children will undergo comprehensive assessments of cognitive, behavioral, and adaptive functioning involving direct testing and input from parents and teachers. Child and parent sleep will be monitored via actigraphy and parent-completed sleep diaries, and parents will report on their stress levels and mood. As a critical first step towards an effective treatment, this initial efficacy study will address 3 aims:

Aim #1: Test the efficacy of manualized BST for improving the sleep of children with DS.

Hypothesis 1: Sleep duration and quality will improve more in the BST condition than the CON condition.

Aim #2: Test the impact of the BST on the daytime functioning of children with DS.

Hypothesis 2: Children receiving BST will make greater gains in inhibitory control, general behavior problems and other measures of executive dysfunction than in the CON condition.

Aim #3: Test whether the BST, which focuses on the child's sleep, also impacts caregivers' sleep and stress.

Hypothesis 3: Parents of children receiving BST will have improved sleep duration and decreased stress.

Conditions

Down Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SMART

Treatment group targeting behavioral sleep problems for 5 weeks.

1. Introduction to the treatment program, an overview of common sleep problems in DS, and the basic principles of the behavioral approach as it relates to sleep problems

2. Information on healthy sleep hygiene, preventative techniques, and use of visual supports

3. Information on reinforcement and extinction procedures for bedtime struggles, codependence, night waking, early waking

4. Information on procedures for delayed sleep onset and problematic sleep associations

5. Feedback on implementation of behavioral sleep treatments and strategies for managing sleep hygiene in the future

Group Type: EXPERIMENTAL

Behavioral Sleep Treatment

Intervention Type: BEHAVIORAL

1. Introduction to the treatment program, an overview of common sleep problems in DS, and the basic principles of the behavioral approach as it relates to sleep problems

2. Information on healthy sleep hygiene, preventative techniques, and use of visual supports

3. Information on reinforcement and extinction procedures for bedtime struggles, codependence, night waking, early waking

4. Information on procedures for delayed sleep onset and problematic sleep associations

5. Feedback on implementation of behavioral sleep treatments and strategies for managing sleep hygiene in the future

WISE

Standard of care sleep treatment enhanced with psychoeducation. 1 Introduction to the general-education program, build rapport with family, and review basic information on Down syndrome 2 Introduction to understanding and interpreting results from clinical evaluations 3 Introduction to educational planning, expectations, and transition planning 4 Introduction to lifespan development and advocacy and support services available 5 Feedback on current concerns and methods for obtaining services to manage concerns

Group Type: ACTIVE_COMPARATOR

Standard of care sleep treatment enhanced with psychoeducation

Intervention Type: BEHAVIORAL

1. Introduction to the general-education program, build rapport with family, and review basic information on Down syndrome

2. Introduction to understanding and interpreting results from clinical evaluations

3. Introduction to educational planning, expectations, and transition planning

4. Introduction to lifespan development and advocacy and support services available

5. Feedback on current concerns and methods for obtaining services to manage concerns

Interventions

Behavioral Sleep Treatment

1. Introduction to the treatment program, an overview of common sleep problems in DS, and the basic principles of the behavioral approach as it relates to sleep problems

2. Information on healthy sleep hygiene, preventative techniques, and use of visual supports

3. Information on reinforcement and extinction procedures for bedtime struggles, codependence, night waking, early waking

4. Information on procedures for delayed sleep onset and problematic sleep associations

5. Feedback on implementation of behavioral sleep treatments and strategies for managing sleep hygiene in the future

Intervention Type: BEHAVIORAL

Standard of care sleep treatment enhanced with psychoeducation

1. Introduction to the general-education program, build rapport with family, and review basic information on Down syndrome

2. Introduction to understanding and interpreting results from clinical evaluations

3. Introduction to educational planning, expectations, and transition planning

4. Introduction to lifespan development and advocacy and support services available

5. Feedback on current concerns and methods for obtaining services to manage concerns

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• diagnosis of Down Syndrome
• 6-17 years of age
• behavioral sleep problem (presence of 5 or more nights a week of: bedtime resistance, delayed sleep onset, problematic sleep associations, nighttime awakenings or morning awakenings)
• English as primary language

Exclusion Criteria

• past diagnosis of Pervasive Developmental Disorder-Not Otherwise Specified/Autism Spectrum Disorder
• History of blindness,deafness,motor impairment
• nonverbal mental age below 36 months
• any medication change w/in past 2 months affecting sleep

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

1R21HD082307-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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