- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03047356
Sleep Intervention
February 6, 2017 updated by: Christopher Armitage, University of Manchester
Effects of "If-then" Plans ("Implementation Intentions") on Adolescent Sleep
A trial that tests whether implementation intentions improve sleep among adoelescents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
151
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 16 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 12-16 years
Exclusion Criteria:
- Unable or unwilling to complete the question
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: First-person "if-then" plan
Participants are asked to form "if-then" plans and the instructions are presented in the first person ("if I...then I...").
"Ifs" are critical situations, "thens" are appropriate responses.
|
"If-then" plans (or "implementation intentions") involve linking in memory critical situations (e.g., temptations) with appropriate responses (e.g., substitution)
|
|
EXPERIMENTAL: Second-person "if-then" plan
Participants are asked to form "if-then" plans and the instructions are presented in the second person ("if you...then you...").
"Ifs" are critical situations, "thens" are appropriate responses.
|
"If-then" plans (or "implementation intentions") involve linking in memory critical situations (e.g., temptations) with appropriate responses (e.g., substitution)
|
|
PLACEBO_COMPARATOR: Control
Participants are presented with "ifs "(critical situations) and "thens" but are not asked to form "if-then" plans.
|
Exposure to critical situations (e.g., temptations) and appropriate responses (e.g., substitution) but not linked in memory
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Achieving recommended sleep levels
Time Frame: 1 month
|
The main outcome measure was adapted from the Pittsburgh Sleep Quality Index (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989), and was designed to tap both quantity and quality of sleep.
Sleep quantity was assessed by asking: "How many hours of actual sleep do you normally get on a night before school?
_________ hours," "What time do you normally go to bed on a night before school?
__________ pm," and "What time do you normally get up on a school day?
__________ am."
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-regulation
Time Frame: 1 month
|
Sniehotta, Nagy, and Scholz's (2006) six items were used to capture three facets of action control (Karoly, 1993) on 7-point (+1 to +7) strongly disagree-strongly agree scales.
(e.g., "During the last month I constantly monitored my sleep on the nights before school")
|
1 month
|
|
Habit
Time Frame: 1 month
|
Gardner et al.'s (2012) self-report behavioral automaticity index, which consists of four items measured on 7-point strongly disagree-strongly agree scales.
The items are: "Getting 9 hours' sleep on the nights before school is something I do automatically," "Getting 9 hours' sleep on the nights before school is something I do without thinking," "Getting 9 hours' sleep on the nights before school is something I do without having to consciously remember," and "Getting 9 hours' sleep on the nights before school is something I start doing before I realize I'm doing it."
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 4, 2016
Primary Completion (ACTUAL)
April 6, 2016
Study Completion (ACTUAL)
April 6, 2016
Study Registration Dates
First Submitted
February 3, 2017
First Submitted That Met QC Criteria
February 6, 2017
First Posted (ESTIMATE)
February 8, 2017
Study Record Updates
Last Update Posted (ESTIMATE)
February 8, 2017
Last Update Submitted That Met QC Criteria
February 6, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- Carding_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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