Trial Outcomes & Findings for Insomnia Prevention in Children With Acute Lymphoblastic Leukemia (NCT NCT05866887)
NCT ID: NCT05866887
Last Updated: 2025-06-06
Results Overview
The primary study outcome of acceptability is defined as the proportion of eligible participants who are approached by research staff who agree to participate in the study, with the cutoff set at ≥30% of eligible participants who are approached agreeing to participate.
COMPLETED
NA
25 participants
At screening, when eligible participants are approached by research staff. Recruitment occurred over a 5-month period.
2025-06-06
Participant Flow
Participant milestones
| Measure |
Sleep ALL Night
Single-arm study where participants receive a single meeting to discuss and review study materials regarding sleep health in pediatric ALL patients.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Sleep ALL Night
n=25 Participants
Single-arm study where participants receive a single meeting to discuss and review study materials regarding sleep health in pediatric ALL patients.
|
|---|---|
|
Age, Continuous
|
5.6 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At screening, when eligible participants are approached by research staff. Recruitment occurred over a 5-month period.Population: The number of participants analyzed (27) is greater than the number enrolled on the study (25) because not all participants were either eligible or interested in study enrollment.
The primary study outcome of acceptability is defined as the proportion of eligible participants who are approached by research staff who agree to participate in the study, with the cutoff set at ≥30% of eligible participants who are approached agreeing to participate.
Outcome measures
| Measure |
Sleep ALL Night
n=27 Participants
Single-arm study where participants receive a single meeting to discuss and review study materials regarding sleep health in pediatric ALL patients.
|
|---|---|
|
Enrollment Rate of Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: At Week 4The primary study outcome of acceptability is defined as participants reporting an average score of ≥4 ("Agree") on the Acceptability of Intervention Measure scale, a four-item questionnaire assessing the acceptability of an intervention. The scale uses a 5-point scale with options ranging from Completely Agree (5) to Completely Disagree (1). The average score of all four items was used as the primary outcome. A higher score indicates greater belief that the intervention was acceptable for the participant.
Outcome measures
| Measure |
Sleep ALL Night
n=22 Participants
Single-arm study where participants receive a single meeting to discuss and review study materials regarding sleep health in pediatric ALL patients.
|
|---|---|
|
Acceptability of Intervention Measure Scale Score
|
4.40 score on a scale
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: Up to 1 month after the conclusion of the study period, up to 8 weeks.Population: Number of participants who completed the Post-Intervention Assessment.
The primary study outcome of feasibility is defined as ≥80% of enrolled participants complete the Post-Intervention Assessment.
Outcome measures
| Measure |
Sleep ALL Night
n=25 Participants
Single-arm study where participants receive a single meeting to discuss and review study materials regarding sleep health in pediatric ALL patients.
|
|---|---|
|
Intervention Assessment Completion Rate
|
22 Participants
|
Adverse Events
Sleep ALL Night
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place