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

NCT02996175 | Completed DMC

• 1 other identifier: 1R21HD082307-01A1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

Behavior; Sleep; Problems; Intervention

Outcome Measures

Primary Outcomes (1)

• Longer child sleep duration as measured by actigraphy and Improved sleep quality for child measure by Children's Sleep Habits Questionnaire (CSHQ)

  33-item Parent reported sleep quality for Child over past week. Each item is scored 1-3 (1 = Rarely, 0-1x/week; 2 = Sometimes, 2-4x/week; 3= Usually, 5-7x/week). There are 6 questions with reverse scoring. This will yield a total between 33 and 99. This will be acquired from parent three times throughout study, data scored and entered into SPSS by coordinator using total score data for comparatives to actigraph results for total sleep.

  Baseline, 6 Weeks, 19 Weeks

Secondary Outcomes (2)

• Improved child behaviors as measured by parent report on Child Behavior Checklist (CBCL)

  Baseline, 6 Weeks, 19 Weeks

• Longer Parent sleep duration as measured by actigraphy and reduced parental stress as measured by the Family Impact Questionnaire (FIQ).

  Baseline, 6 Weeks, 19 Weeks

Study Arms (2)

SMART

EXPERIMENTAL

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

Behavioral: Behavioral Sleep Treatment

WISE

ACTIVE COMPARATOR

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

Behavioral: Standard of care sleep treatment enhanced with psychoeducation

Interventions

Behavioral Sleep Treatment 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

SMART

Standard of care sleep treatment enhanced with psychoeducation 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

WISE

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• diagnosis of Down Syndrome
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Down Syndrome; Behavior

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 19, 2016
• Study Start: July 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 4, 2018

Record last verified: 2018-06

Locations

US (1)