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

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.

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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