NCT03047356

Brief Summary

A trial that tests whether implementation intentions improve sleep among adoelescents.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

February 3, 2017

Last Update Submit

February 6, 2017

Conditions

Mental

Outcome Measures

Primary Outcomes (1)

  • Achieving recommended sleep levels

    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 Outcomes (2)

  • Self-regulation

    1 month

  • Habit

    1 month

Study Arms (3)

First-person "if-then" plan

EXPERIMENTAL

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.

Behavioral: "If-then" plans

Second-person "if-then" plan

EXPERIMENTAL

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.

Behavioral: "If-then" plans

Control

PLACEBO COMPARATOR

Participants are presented with "ifs "(critical situations) and "thens" but are not asked to form "if-then" plans.

Other: Control

Interventions

"If-then" plansBEHAVIORAL

"If-then" plans (or "implementation intentions") involve linking in memory critical situations (e.g., temptations) with appropriate responses (e.g., substitution)

First-person "if-then" planSecond-person "if-then" plan
ControlOTHER

Exposure to critical situations (e.g., temptations) and appropriate responses (e.g., substitution) but not linked in memory

Control

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 12-16 years

You may not qualify if:

  • Unable or unwilling to complete the question

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Health Psychology

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 8, 2017

Study Start

March 4, 2016

Primary Completion

April 6, 2016

Study Completion

April 6, 2016

Last Updated

February 8, 2017

Record last verified: 2017-02