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Improving Memory for Sleep Treatment Content With Text Messages

Primary Purpose

Sleep Wake Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PUSH text messages
PULL text messages
TranS-C
PE
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Wake Disorders

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Scoring within the lowest quartile of the Children's Morningness-Eveningness Preferences Scale (CMEP; 27 or lower) and a 7-day sleep diary showing a sleep onset time of of 10:40 pm or later for 10-13 year olds, 11 pm or later for 14-16 year olds, and 11:20 pm or later for 17-18 year olds at least 3 nights per week. Must have had the current pattern of late bedtimes for the last 3 months.
  2. 'At risk' in one of the five health domains: emotional, behavioral, social, physical, and cognitive. Emotional risk will be operationalized as a score of 4 or above on any of the following items on the Child Depression Rating Scale: Difficulty Having Fun, Social Withdrawal, Irritability, Depressed Feelings, Excessive Weeping, or a T-score of 61 or above on the Multidimensional Anxiety Scale for Children (MASC), based on age group (10-11 years, 12-15 year, 16-19 years) using the MASC-10 Profile. Behavioral risk will be operationalized as a Sensation Seeking Scale score greater than 3.93 for males ages 10-13, greater than 3.19 for females 10-13, greater than 4.07 for males 14-18, or greater than 3.19 for females 14-18; taking ADHD medication or Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADs) diagnosis of ADHD; current alcohol or substance abuse; or past alcohol or substance dependence. Social and cognitive risk will be defined as "worse" than others the teen's age in one or more social behavior from Child Behavior Checklist (CBCL) Section VI or failing one or more academic class from CBCL Section VII, respectively. Physical risk will be operationalized as a Physical Health Questionnaire-15 score of 4 or above, six or more days of school absences, or a BMI above the 85th percentile for the participant's sex and age.
  3. Age between 10 and 18 and living with a parent or guardian and and attending a class/job by 9am at least 3 days per week;
  4. English language fluency;
  5. Able and willing to give informed assent.

Exclusion Criteria:

  1. An active, progressive physical illness (e.g., cancer, respiratory disorder) or neurological degenerative disease directly related to the onset and course of the sleep disturbance;
  2. Evidence from clinical diagnosis or report by youth or parent of sleep apnea, restless legs or periodic limb movements during sleep. Youth presenting with provisional diagnoses of any of these disorders (e.g., sleep apnea) will be referred for a non-study polysomnography (PSG) evaluation at the parent's discretion and will be enrolled only if the diagnosis is disconfirmed;
  3. Mental retardation, autism spectrum disorder, or other significantly impairing pervasive developmental disorder. Based on previous recruitment experiences in a youth depression study, it is expected that this exclusion will be invoked very infrequently (once every few years);
  4. Bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study. Otherwise, all other comorbid psychiatric conditions will be allowed to (i) to maximize representativeness and (ii) because a byproduct may be that the treatment constitutes a helpful 'transdiagnostic' treatment for youth across psychiatric disorders.
  5. A medication-free group may be difficult to recruit and would likely be unrepresentative. Hence, participants will not be excluded on the basis of stable use of medications (> 4 weeks). The exception was use of hypnotics and other medications known to alter sleep (e.g., melatonin).
  6. History of substance dependence in the past six months;
  7. Current suicide risk sufficient to preclude treatment on an outpatient basis.

Sites / Locations

  • University of California, Berkeley

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

PUSH text messages

PULL text messages

No text messages

Arm Description

Participants will be sent text messages containing information relevant to their treatment condition (i.e., TranS-C or PE).

Participants will be sent text messages containing information relevant to their treatment condition (i.e., TranS-C or PE). Text messages will request a response from the participant.

No text messages will be sent in this condition to participants in either treatment condition (i.e., TranS-C or PE).

Outcomes

Primary Outcome Measures

Total sleep time (TST) average on weeknights via Daily Sleep Diary
6mo TST
Total sleep time (TST) average on weeknights via Daily Sleep Diary
12mo TST
Average bedtime on weeknights measured via Daily Sleep Diary
6mo Avg Bedtime
Average bedtime on weeknights measured via Daily Sleep Diary
12mo Avg Bedtime
Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale
6mo CME
Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale
12mo CME
Patient Recall of Session Contents
6-12mo Change in Patient Recall

Secondary Outcome Measures

Sleepiness scale
Embedded within the School Sleep Habits Survey
Sleepiness scale
Embedded within the School Sleep Habits Survey
Pittsburgh Sleep Quality Index
6mo PSQI
Pittsburgh Sleep Quality Index
12mo PSQI
Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary
6mo Weeknight-Weekend Differences
Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary
12mo Weeknight-Weekend Differences
Text Message Evaluation
Measure of the acceptability of receiving text messages
Child Behavior Checklist
Parent measure
Child Behavior Checklist
Parent measure

Full Information

First Posted
October 17, 2016
Last Updated
October 28, 2019
Sponsor
University of California, Berkeley
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1. Study Identification

Unique Protocol Identification Number
NCT02961400
Brief Title
Improving Memory for Sleep Treatment Content With Text Messages
Official Title
Improving Memory for Sleep Treatment Content With Text Messages
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Berkeley

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A drop off in improvement over the months and years after treatment is common. One contributor may be poor memory for the contents of treatment. This study seeks to determine whether text messages containing reminders of the content of sessions will improve treatment outcomes.
Detailed Description
The growth in the use of technology provides an opportunity to send reminders to participants via text messages. The early studies on text messaging interventions indicate this approach is enjoyable for participants and has positive effects across a range of domains and treatment types. Hence, this study will test whether text messages containing reminders of the content of sessions will improve treatment outcomes. Two text messaging methods will also be tested. One is to send text messages to remind participants of their goals (PUSH condition) and the second is to send text messages to remind participants to recall their goals (PULL condition). This study will be conducted within the context of an NICHD-funded Randomized Controlled Trial (grant number R01-HD071065; protocol registration ID NCT01828320). In R01-HD071065 adolescents ages 10-18 (n = 176) will receive either the Transdiagnostic Sleep and Circadian Intervention (TranS-C) or a Psychoeducation (PE). At the 6-month follow-up assessment for R01-HD071065, participants will be randomized using 3 (PUSH text messages, PULL text messages, or no text messages) x 2 (TranS-C or PE) design. At the 6-month follow-up assessment, a questionnaire will also be administered to establish baseline memory for treatment. Participants will be sent text messages once per week until they return for the 12 month follow-up assessment for R01-HD071065. At the 12 month follow-up assessment, participants will be asked to complete the same memory for treatment questionnaire completed at the 6 month follow-up assessment as well as a questionnaire evaluating the acceptability of the text message reminders. This research is a first step toward identifying whether an inexpensive and ubiquitous technology (i.e., text messaging) can improve memory for treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Wake Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PUSH text messages
Arm Type
Experimental
Arm Description
Participants will be sent text messages containing information relevant to their treatment condition (i.e., TranS-C or PE).
Arm Title
PULL text messages
Arm Type
Experimental
Arm Description
Participants will be sent text messages containing information relevant to their treatment condition (i.e., TranS-C or PE). Text messages will request a response from the participant.
Arm Title
No text messages
Arm Type
Other
Arm Description
No text messages will be sent in this condition to participants in either treatment condition (i.e., TranS-C or PE).
Intervention Type
Other
Intervention Name(s)
PUSH text messages
Intervention Description
The intervention is designed to remind participants of treatment components.
Intervention Type
Other
Intervention Name(s)
PULL text messages
Intervention Description
The intervention is designed to remind participants to recall treatment components.
Intervention Type
Behavioral
Intervention Name(s)
TranS-C
Other Intervention Name(s)
Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy
Intervention Description
The Transdiagnostic Sleep and Circadian Intervention (TranS-C) integrates evidence-based treatments derived from basic research on the circadian system.
Intervention Type
Behavioral
Intervention Name(s)
PE
Other Intervention Name(s)
Psychoeducation
Intervention Description
Psychoeducation on the inter-associations between sleep, diet, exercise and stress.
Primary Outcome Measure Information:
Title
Total sleep time (TST) average on weeknights via Daily Sleep Diary
Description
6mo TST
Time Frame
Measured at 6-months post-treatment
Title
Total sleep time (TST) average on weeknights via Daily Sleep Diary
Description
12mo TST
Time Frame
Measured at 12-months post-treatment
Title
Average bedtime on weeknights measured via Daily Sleep Diary
Description
6mo Avg Bedtime
Time Frame
Measured at 6-months post-treatment
Title
Average bedtime on weeknights measured via Daily Sleep Diary
Description
12mo Avg Bedtime
Time Frame
Measured at 12-months post-treatment
Title
Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale
Description
6mo CME
Time Frame
Measured at 6-months post-treatment
Title
Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale
Description
12mo CME
Time Frame
Measured at 12-months post-treatment
Title
Patient Recall of Session Contents
Description
6-12mo Change in Patient Recall
Time Frame
Change from 6-months post-treatment to 12-months post-treatment
Secondary Outcome Measure Information:
Title
Sleepiness scale
Description
Embedded within the School Sleep Habits Survey
Time Frame
Measured at 6-months post-treatment
Title
Sleepiness scale
Description
Embedded within the School Sleep Habits Survey
Time Frame
Measured at 12-months post-treatment
Title
Pittsburgh Sleep Quality Index
Description
6mo PSQI
Time Frame
Measured at 6-months post-treatment
Title
Pittsburgh Sleep Quality Index
Description
12mo PSQI
Time Frame
Measured at 12-months post-treatment
Title
Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary
Description
6mo Weeknight-Weekend Differences
Time Frame
Measured at 6-months post-treatment
Title
Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary
Description
12mo Weeknight-Weekend Differences
Time Frame
Measured at 12-months post-treatment
Title
Text Message Evaluation
Description
Measure of the acceptability of receiving text messages
Time Frame
Measured at 12-months post-treatment
Title
Child Behavior Checklist
Description
Parent measure
Time Frame
Measured at 6-months post-treatment
Title
Child Behavior Checklist
Description
Parent measure
Time Frame
Measured at 12-months post-treatment
Other Pre-specified Outcome Measures:
Title
Useful and Utilized Questionnaire
Description
6mo UUQ
Time Frame
Measured at 6-months post-treatment
Title
Useful and Utilized Questionnaire
Description
12mo UUQ
Time Frame
Measured at 12-months post-treatment
Title
Daily Sleep Diary
Description
total sleep time (weekend nights), weeknight bedtime, weekend risetime, total wake time (SOL+WASO) weeknights, total wake time (SOL+WASO) weekend nights, naps.
Time Frame
Measured at 6-months post-treatment
Title
Daily Sleep Diary
Description
total sleep time (weekend nights), weeknight bedtime, weekend risetime, total wake time (SOL+WASO) weeknights, total wake time (SOL+WASO) weekend nights, naps.
Time Frame
Measured at 12-months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scoring within the lowest quartile of the Children's Morningness-Eveningness Preferences Scale (CMEP; 27 or lower) and a 7-day sleep diary showing a sleep onset time of of 10:40 pm or later for 10-13 year olds, 11 pm or later for 14-16 year olds, and 11:20 pm or later for 17-18 year olds at least 3 nights per week. Must have had the current pattern of late bedtimes for the last 3 months. 'At risk' in one of the five health domains: emotional, behavioral, social, physical, and cognitive. Emotional risk will be operationalized as a score of 4 or above on any of the following items on the Child Depression Rating Scale: Difficulty Having Fun, Social Withdrawal, Irritability, Depressed Feelings, Excessive Weeping, or a T-score of 61 or above on the Multidimensional Anxiety Scale for Children (MASC), based on age group (10-11 years, 12-15 year, 16-19 years) using the MASC-10 Profile. Behavioral risk will be operationalized as a Sensation Seeking Scale score greater than 3.93 for males ages 10-13, greater than 3.19 for females 10-13, greater than 4.07 for males 14-18, or greater than 3.19 for females 14-18; taking ADHD medication or Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADs) diagnosis of ADHD; current alcohol or substance abuse; or past alcohol or substance dependence. Social and cognitive risk will be defined as "worse" than others the teen's age in one or more social behavior from Child Behavior Checklist (CBCL) Section VI or failing one or more academic class from CBCL Section VII, respectively. Physical risk will be operationalized as a Physical Health Questionnaire-15 score of 4 or above, six or more days of school absences, or a BMI above the 85th percentile for the participant's sex and age. Age between 10 and 18 and living with a parent or guardian and and attending a class/job by 9am at least 3 days per week; English language fluency; Able and willing to give informed assent. Exclusion Criteria: An active, progressive physical illness (e.g., cancer, respiratory disorder) or neurological degenerative disease directly related to the onset and course of the sleep disturbance; Evidence from clinical diagnosis or report by youth or parent of sleep apnea, restless legs or periodic limb movements during sleep. Youth presenting with provisional diagnoses of any of these disorders (e.g., sleep apnea) will be referred for a non-study polysomnography (PSG) evaluation at the parent's discretion and will be enrolled only if the diagnosis is disconfirmed; Mental retardation, autism spectrum disorder, or other significantly impairing pervasive developmental disorder. Based on previous recruitment experiences in a youth depression study, it is expected that this exclusion will be invoked very infrequently (once every few years); Bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study. Otherwise, all other comorbid psychiatric conditions will be allowed to (i) to maximize representativeness and (ii) because a byproduct may be that the treatment constitutes a helpful 'transdiagnostic' treatment for youth across psychiatric disorders. A medication-free group may be difficult to recruit and would likely be unrepresentative. Hence, participants will not be excluded on the basis of stable use of medications (> 4 weeks). The exception was use of hypnotics and other medications known to alter sleep (e.g., melatonin). History of substance dependence in the past six months; Current suicide risk sufficient to preclude treatment on an outpatient basis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison G Harvey, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael R Dolsen
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States

12. IPD Sharing Statement

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Improving Memory for Sleep Treatment Content With Text Messages

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