NCT02365025

Brief Summary

Amongst adolescents, there is a gap that widens with age between recommended sleep duration and actual sleep time. Due to this gap, bodily and mental functions such as those related to the metabolic and immune systems, performance, memory, school achievement and creative ability can be harmed. Moreover, lack of sleep involves an increased risk of accidents and injuries, behavior problems and reduced quality of life. Biological factors that explain changes in sleep patterns include delays in the circadian timing system and in the homeostatic system that regulate sleep and wakefulness. These changes cause a growing and continuous delay in sleep phase during adolescence. In addition, a number of environmental factors affect sleep patterns: variables such as early school start time, increased homework assignments, after-school activities, lack of parental demand for adequate sleep hours, and increased "screen time," or use of electronic media, including television, computer games, internet and cellular phones. Based on the Parental Style model, the authoritative parenting style is characterized by parents setting high demands on their children on the one hand and displaying high levels of responsiveness to their children on the other. The authoritarian parenting style is characterized by parents setting high demands on their children on the one hand yet displaying low levels of responsiveness to their children on the other. The permissive parenting style is characterized by parents setting low demands on their children and displaying high levels of responsiveness to their children. In several investigations, the authoritative parenting style has been shown to have a positive influence on child development, academic achievement and psychosocial competency, and promoted healthy behaviors in adolescents, such as good eating habits, increased physical activity and a decrease in risky behaviors such as smoking, alcohol abuse, extreme diets and early sexual behavior. The Conceptual Model views parents as the sole agents of change in their children's life, and focuses on the power of personal example, environmental changes and promotion of the authoritative parental style. The main aim of this research is to evaluate the effectiveness of an intervention program that deals with increasing parents' awareness of the changes that characterize adolescents and encourages the authoritative parental style based on the Parenting Style Model.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2011

Typical duration for phase_4

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

February 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

January 25, 2015

Last Update Submit

February 10, 2015

Conditions

Keywords

Sleep patternsElectronic Media ExposureParental Intervention

Outcome Measures

Primary Outcomes (1)

  • Sleep Habits

    Sleep Habits measured by: Bedtime hour, sleep latency, wake-up time, total sleep, daytime sleepiness, depressed mood, sleep problem behaviors and morningness-eveningness duration both on weekdays and weekends.

    Two years

Secondary Outcomes (2)

  • Parents Knowledge regarding Sleep and Media

    Two Years

  • Quantity of media exposure

    Two years

Other Outcomes (2)

  • Quality of life

    Two Years

  • Parental Authority

    Two Years

Study Arms (2)

Experimental group

EXPERIMENTAL

Step 1: Patients and parents enrolment. Step 2: The parents of the children assigned to the experimental group will fill a questionaire related to familial and social background, electronic media exposure and sleep characteristics of their children. Step 3: Parents of the children assigned to this group will participate in 6 meetings guides by experts in sleeping disorders. In those meeting the parents will be exposed to sleep disturbances, the importance of sleep habits and the influence of electronic media on sleep and learning. Step 4: Re evaluation by questioners after the 6 meetings participation. Step 5: 3 months follow up after the intervention (Meetings).

Other: Meetings guides by experts in sleeping disorders.

Control group

NO INTERVENTION

Step 1: Patients and parents enrolment. Step 2: The parents of the children assigned to the control group will fill a questionaire related to familial and social background, electronic media exposure and sleep characteristics of their children. Step 3: Parents of the children assigned to this group will not participate in the meetings as described in the experimental group. Step 4: Re evaluation by questioners after the time that the experimental group participated in the meetings. Step 5: 3 months follow up.

Interventions

meetings guides by experts in sleeping disorders. In those meeting the parents will be exposed to sleep disturbances, the importance of sleep habits and the influence of electronic media on sleep and learning.

Experimental group

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Teenagers aged 10 to 12 years, Hebrew speaking and healthy.
  • Hebrew speaking parents.

You may not qualify if:

  • Teenagers suffering from chronic diseases of diseases that leads to learning disabilities.
  • Teenagers who live in homes without exposure to electronical media.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ariel Koren, MD

    HaEmek Medical Center - Afula - IsRAEL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Dept B

Study Record Dates

First Submitted

January 25, 2015

First Posted

February 18, 2015

Study Start

February 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 18, 2015

Record last verified: 2015-02