COA At-a-Glance
Evidence of cognitive interviewing of draft instrument in target patient population
Evidence of internal consistency
Evidence of test-retest or inter-rater reliability
Evidence of concurrent validity
Evidence of known-groups validity
Evidence of ability to detect change over time
Evidence of responder thresholds
Inclusion of the COA in product labelling
- Overview
- Content Validity
- Reliability
- Validity
- Ability to Detect Change
- Responder Thresholds
- Reference(s) of development / validation
- Other references
- Inclusion of the COA in product labelling
- Inclusion of the COA in product labelling (agency, drug, drug approval date, COA results) from PROLABELS search
- Existence of Scoring / Interpretation / User Manual
- Original language and translations
- References of translations
- Authors and contact information
- Condition of use: copyright
- Website
- Review copy
Overview
Instrument Name: Children's Sleep-Wake Scale
Abbreviation: CSWS
Points for Consideration:
None
Description of Tool:
The Children’s Sleep-Wake Scale (CSWS) is a 25-item ObsRO developed to measure sleep quality in pre-school and early school-aged children (2-8 years). Caregivers are asked to indicate how often sleep behaviours have occurred in their child during the past month using a 6-level scale ranging from 1= “Never”, 2=“Once in a while”, 3=“Sometimes”, 4=“Quite often”, 5=“Frequently-if-not always”, to 6=“Always”. A higher score indicates better sleep quality.
Other Related Tools (if applicable):
The Adolescent Sleep-Wake Scale (ASWS) consists of 28 items and is a PRO measure for use in adolescents 12-18 years old. The ASWS was further revised based on the results of an exploratory factor analysis, resulting in a 10-item PRO.
Minimum Qualification Required by COA Administrator: No degree requirement
Comment:
None
Year: 2001
Objective of Development:
To measure sleep quality in children aged 2-8 years.
Population of Development: Age range (therapeutic indication):
Age range: 2-8 years (No therapeutic indication)
Pediatric Population(s) in which COA has been used:
None identified
COA type: ObsRO
Number of Items 25
Mode of Administration: Caregiver-rated
Data Collection Mode: Paper and pen administration
Time for Completion: No information
Response Scales: 6-point Likert scale ranging from 1= “Never”, 2=“Once in a while”, 3=“Sometimes”, 4=“Quite often”, 5=“Frequently-if-not always” to 6=“Always”
Summary of Scoring:
Available scores: The CSWS provides 5 subscale scores and an overall sleep quality score. Response options are scored as follows: Never (1 point), Once in Awhile (2 points), Sometimes (3 points), Quite Often (4 points), Frequently, if not Always (5 points) and Always (6 points). Reverse scoring is needed for some items.
Weighting: No
Score interpretation: Higher scores=Better sleep success on each of the dimensions (or sleep quality)
Content Validity
Evidence of Literature Review: Yes
Evidence of Instrument Review: None identified
Evidence of Clinical or Expert Input: Yes
Evidence of concept elicitation in target patient population: None identified
Evidence of a Saturation Grid: None identified
Evidence for Selection of Data Collection Method: None identified
Recall/Observation Period: Past month
Evidence for Selection of Reponse Options: Yes
Evidence of cognitive interviewing of draft instrument in target patient population: Yes
Evidence of Preliminary Scoring of Items and Domains: None identified
Evidence related to respondent and administrator burden: None identified
Evidence of a Conceptual Framework: Yes
Evidence of an item-tracking matrix: None identified
Evidence related to item selection: Yes
Evidence of re-testing the final version: Yes
Reliability
Internal consistency (Cronbach's alpha): Yes
Evidence of internal consistency: LeBourgeois MK (2003) - Method: Cronbach's alpha - Results: 0.70-0.93 - Population/Disease: Primary caregivers of children 2-5 years old; n=161 LeBourgeois MK (2003) - Method: Cronbach's alpha - Results: 0.71-0.94 - Population/Disease: Primary caregivers of children 2-8 years old; n=485 LeBourgeois MK (2016) - Method: Cronbach's alpha - Results: 0.81-0.91 - Population/Disease: Primary caregivers of children 2-8 years old; n=543.
Test-retest Reliability (ICC):
LeBourgeois MK (2016)
Test-retest reliability
- Correlation coefficient not stated: The temporal stability assessment of the CSWS showed a reliability coefficient of r = 0.85 (P < .001) for the CSWS total scale and the following subscale coefficients (all P values < .001): Going to bed (r = 0.84), Falling aleep (r = 0.78), Maintaining Sleep, (r = 0.75), Reinitiating Sleep (r = 0.67), and Returning to wakefullness (r = 0.70).
- Was a definition of stability applied to identify stable patients: Not stated
- Time frame between the two administrations: one month
- Population/disease: Primary caregivers of children 2-8 years old; n=36
Inter-rater/ inter-interviewer reliability (kappa):
None identified
Evidence of test-retest or inter-rater reliability: Yes
Validity
Concurrent validity (convergent, divergent):
LeBourgeois MK (2003)
Convergent validity
- Correlation coefficient used: Pearson product moment correlation coefficient
- Measures: Sleep diary and actigraphy
- Results:
Moderate relationship was found between the Going to Bed (GB), Falling Asleep (FA), and Returning To Wakefulness (RTW) subscales and corresponding caretaker sleep diary ratings. For the Maintaining Sleep (MS) and Reinitiating Sleep (RS) subscales, the correlations were less than predicted (r = .52), but were still in the moderate range. FA subscale scores were moderately related to the actigraph measure of sleep onset latency. The relationship between scores on the MS subscale and the immobility time (%) actigraphic variable were significant and positive, but did not meet the hypothesized strength of r > .60. Likewise, the association between scores on the RS subscale and children’s longest wake bout was significant and negative, but not as strong as predicted.
- Population/Disease: Children aged 2-8 years; n=77 for sleep diary correlations; n=64 for actigraphy correlations
LeBourgeois MK (2016)
Convergent validity
- Correlation coefficient used: Pearson correlation coefficient
- Measures: Sleep diary and actigraphy
- Results: Moderate-to-strong correlations between the Children's Sleep-Wake Scale (CSWS) subscale scores and corresponding parental diary ratings (r = 0.58–r = 0.72; all P values < .001), and weak-to-moderate correlations between CSWS subscales and actigraphic measures (r = 0.38–r = 0.61; all P values < .001)
- Population/Disease: Children aged 2-8 years; n=69
Known-group validity:
LeBourgeois MK (2003)
- Measure/Groups of patients: Prior to administration of the CSWS, caretakers were asked if their child had a problem along each of the five dimensions and if their child was a poor sleeper. Caretakers that responded “yes” to these questions were also asked the severity of the problem (mild, moderate, or severe). Their ratings were compared with the respective subscale scores of the CSWS and the total scale score.
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Mean subscale scores were lower for children whose caretakers described them as having a problem on the respective sleep dimension. Caretaker ratings of problem severity of each dimension were most highly correlated with the scores for the CSWS subscale assessing that dimension (r = -.32 to -.57; p < .001).
- Population/disease: Primary caregivers of children 2-8 years old; n=485
LeBourgeois MK (2003)
- Measure/Groups of patients: Exceptionally Good Sleepers (GS), Children with Behavior Problems (BP), Children with Sleep-Onset Association Problems (SOA) and Community Controls (CC).
- A priori hypotheses:
Subscale scores for the GS group will be significantly higher than subscale scores for the CC, BP, and SOA groups (a=.05).
The Going to Bed subscale score for the BP group will be significantly lower than subscale scores for the GS and CC, and SOA groups (a=.05).
The Falling Asleep subscale scores for the BP and SOA groups will be significantly lower than subscale scores for the GS and CC groups (a=.05).
The Maintaining Sleep and Reinitiating Sleep subscale scores for the SOA group will be significantly lower than subscale scores for the GS, CC, and BP groups (a=.05).
- Were hypotheses confirmed: Yes
- Results: Independent-samples t tests. As predicted, participants in the GS group had better sleep quality on all CSWS subscales (GTB, FA, MS, RS, RTW) than participants in the other three study groups. Examination of group mean scores on the GTB subscale revealed that participants in the BP group had the lowest subscale scores and that participants in the SOA group had the next lowest scores. Inspection of group mean FA scores revealed the lowest score (M = 3.4) for both the BP and SOA groups and the next lowest score for the CC group.
Children in the SOA group had significantly poorer sleep quality in terms of maintaining and reinitiating sleep (lower subscale scores) than children in the other three study groups.
- Population/disease: Children 2-8 years old; n=79
LeBourgeois MK (2016)
- Measure:Sleep Diary/Actigraphy
- Groups of patients: Exceptionally Good Sleepers (GS), Children with Behavior Problems (BP), Children with Sleep-Onset Association Problems (SOA) and Community Controls (CC).
- A priori hypotheses:
GS group subscale and total CSWS scores would be higher than those of the CC, BP, and SOA groups;
BP group Going to Bed subscale scores would be lower than the GS, CC, and SOA groups;
BP and SOA groups Falling Asleep subscale scores would be lower than the GS and CC groups;
SOA group Maintaining Sleep and Reinitiating Sleep subscale scores would be lower than those of the GS, CC, and BP groups;
BP and SOA total CSWS total scores would be lower than the GS and CC groups.
- Were hypotheses confirmed: Yes
- Results: Independent-samples t tests
In all comparisons, the mean scores (data available in the article) were statistically different from the matched group.
- Population/disease: Children aged 2-8 years; n=85
Evidence of Translatability Assessment: None identified
Evidence related to missing data: None identified
Evidence for Selection of Recall Period: None identified
Evidence of Administration Instructions and Training Provided: None identified
Evidence of concurrent validity: Yes
Evidence of known-groups validity: Yes
Evidence of ability to detect change over time: None identified
Ability to Detect Change
Ability to detect change (Responsiveness):
None identified
Responder Thresholds
Responder Thresholds:
None identified
Evidence of responder thresholds: None identified
Reference(s) of development / validation
LeBourgeois, M. K., Hancock, M. H., & Harsh, J. R. (2001). Validation of the Children's Sleep-Wake scale (CSWS). Sleep, 24, A218. Full Text Article: None identified
LeBourgeois, M. K., & Harsh, J. R. (2001). A new research measure for children's sleep. Sleep, 24, A213. Full Text Article: None identified
LeBourgeois, M. K. (2003). Validation of the children's sleep-wake scale. The University of Southern Mississippi. Full Text Article: https://www.proquest.com/openview/f5ad476100c91d2e1e6fbb77047fa572/1?pq-origsite=gscholar&cbl=18750&diss=y
LeBourgeois MK, Harsh JR. Development and psychometric evaluation of the Children's Sleep-Wake Scale. Sleep Health. 2016 Sep;2(3):198-204 Full Text Article: https://pubmed.ncbi.nlm.nih.gov/28066802/
Other references
LeBourgeois MK, Giannotti F, Cortesi F, Wolfson AR, Harsh J. The relationship between reported sleep quality and sleep hygiene in Italian and American adolescents. Pediatrics. 2005 Jan;115(1 Suppl):257-65. doi: 10.1542/peds.2004-0815H. PMID: 15866860; PMCID: PMC3928632. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/15866860/
Essner B, Noel M, Myrvik M, Palermo T. Examination of the Factor Structure of the Adolescent Sleep-Wake Scale (ASWS). Behav Sleep Med. 2015;13(4):296-307. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/24742264/
Inclusion of the COA in product labelling
None identified
Inclusion of the COA in product labelling (agency, drug, drug approval date, COA results) from PROLABELS search
None identified
Existence of Scoring / Interpretation / User Manual
Yes
Original language and translations
Original language: English for the USA
References of translations
None identified
Condition of use: copyright
None identified
Website
None identified
Review copy
https://pmc.ncbi.nlm.nih.gov/articles/instance/5215091/bin/NIHMS838700-supplement-CSWS.pdf