SleepPhase 4NCT02365025
The Effects of a Parental Intervention on Electronic Media Exposure and Sleep Patterns in Adolescents
A Phase 4 study testing Meetings guides by experts in sleeping disorders. in people with Sleep, run by HaEmek Medical Center, Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Meetings guides by experts in sleeping disorders.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Teenagers aged 10 to 12 years, Hebrew speaking and healthy.
- Hebrew speaking parents.
Who cannot join
- Teenagers suffering from chronic diseases of diseases that leads to learning disabilities.
- Teenagers who live in homes without exposure to electronical media.
About this study
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.
Read more
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.
Read the detailed description
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. This model has been found to be effective in the field of eating disorders but has never been implemented in the field of sleep.
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; it also encourages parents to make environmental changes at home based on the Conceptual Model in order to promote healthy behaviors including healthy sleep patterns and controlled exposure to electronic media in young normative adolescents (ages 10-12) .
Research Hypotheses:
Hypothesis 1: There is a link between availability and the amount of time spent using electronic media. Adolescents who have media devices in their rooms are exposed for longer hours to electronic media compared to those who do not have media devices in their rooms. In addition, there is a link between the availability of the media devices and sleep patterns. Adolescents who have media devices in their rooms will show delayed sleep patterns and shorter sleep durations compared to those who do not.
Hypothesis 2: There is a connection between parental style, sleep patterns and media exposure habits in young adolescents. Children of parents with an authoritative style would exhibit proper sleep patterns and exposure to electronic media; and children whose parents have an authoritarian parental style would have longer sleep durations and less exposure to electronic media compared with other parenting styles. It was assumed that children whose parents exhibit the permissive parental style would have shorter sleep duration and more exposure to electronic media compared to other parenting styles.
Hypothesis 3: There is a connection between sleep patterns, media exposure habits and quality of life in young adolescents. The study will find that better sleep patterns and lower exposure to electronic media are related to higher quality of life in young adolescents.
Hypothesis 4: The intervention program based on the Conceptual Model will lead to an increase in parents' knowledge about the changes that characterize adolescents and will promote the authoritative parental style.
Hypothesis 5: The intervention program will lead to an improvement in healthy behaviors, including better sleep patterns, controlled use of electronic media, better quality of life of young adolescents.
Method The sample included 70 dyads of parents (mostly mothers) and adolescents from schools in the Jezreel Valley. The experimental group and the control group each consisted of 35 participants (35 girls) of average age 10.7 (0.9) years. There were three sessions of data collection: 1. baseline, 2. immediately following intervention, 3. three months post-intervention. Parents and adolescents reported on electronic media consumption, sleep patterns and quality of life. In addition, parents reported on their parenting styles and adolescents wore an ActiGraph (for monitoring their sleep patterns) and filled in a sleep diary for five days. Parents in the experimental group participated in six workshops, while parents in the control group received information regarding healthy sleep habits and the effects of excessive media exposure by mail and were expected to read it on their own.
- Conditions
- Sleep
- Being tested
- Meetings guides by experts in sleeping disorders.
- Keywords
- Sleep patterns, Electronic Media Exposure, Parental Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meetings guides by experts in sleeping disorders.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Secondary outcomes (2)
Parents Knowledge regarding Sleep and Media
Parents Knowledge regarding Sleep and Media regarding the importance of sleep in adolescence and issues regarding good sleep hygiene.
Measured: Two Years
Quantity of media exposure
Quantity of media exposure including whether or not teenagers have television/computer in their bedroom and the use of television, computer games, internet and total media in hours per day
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Koren Ariel, HaEmek Medical Center, Israel
- Investigators
- Ariel Koren, MD, Principal investigator, HaEmek Medical Center - Afula - IsRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365025
- Sponsor's protocol ID
- 0075-10-EMC
- Status last verified
- Feb 2015
- First submitted
- 25 Jan 2015
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Parental Intervention on Electronic Media Exposure and Sleep Patterns in Adolescents
- ClinicalTrials.gov ID
- NCT02365025
- Acronym / sponsor ID
- 0075-10-EMC
- Conditions
- Sleep
- Keywords
- Sleep patterns, Electronic Media Exposure, Parental Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. This model has been found to be effective in the field of eating disorders but has never been implemented in the field of sleep.
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; it also encourages parents to make environmental changes at home based on the Conceptual Model in order to promote healthy behaviors including healthy sleep patterns and controlled exposure to electronic media in young normative adolescents (ages 10-12) .
Research Hypotheses:
Hypothesis 1: There is a link between availability and the amount of time spent using electronic media. Adolescents who have media devices in their rooms are exposed for longer hours to electronic media compared to those who do not have media devices in their rooms. In addition, there is a link between the availability of the media devices and sleep patterns. Adolescents who have media devices in their rooms will show delayed sleep patterns and shorter sleep durations compared to those who do not.
Hypothesis 2: There is a connection between parental style, sleep patterns and media exposure habits in young adolescents. Children of parents with an authoritative style would exhibit proper sleep patterns and exposure to electronic media; and children whose parents have an authoritarian parental style would have longer sleep durations and less exposure to electronic media compared with other parenting styles. It was assumed that children whose parents exhibit the permissive parental style would have shorter sleep duration and more exposure to electronic media compared to other parenting styles.
Hypothesis 3: There is a connection between sleep patterns, media exposure habits and quality of life in young adolescents. The study will find that better sleep patterns and lower exposure to electronic media are related to higher quality of life in young adolescents.
Hypothesis 4: The intervention program based on the Conceptual Model will lead to an increase in parents' knowledge about the changes that characterize adolescents and will promote the authoritative parental style.
Hypothesis 5: The intervention program will lead to an improvement in healthy behaviors, including better sleep patterns, controlled use of electronic media, better quality of life of young adolescents.
Method The sample included 70 dyads of parents (mostly mothers) and adolescents from schools in the Jezreel Valley. The experimental group and the control group each consisted of 35 participants (35 girls) of average age 10.7 (0.9) years. There were three sessions of data collection: 1. baseline, 2. immediately following intervention, 3. three months post-intervention. Parents and adolescents reported on electronic media consumption, sleep patterns and quality of life. In addition, parents reported on their parenting styles and adolescents wore an ActiGraph (for monitoring their sleep patterns) and filled in a sleep diary for five days. Parents in the experimental group participated in six workshops, while parents in the control group received information regarding healthy sleep habits and the effects of excessive media exposure by mail and were expected to read it on their own.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Meetings guides by experts in sleeping disorders.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). |
| 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. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Teenagers aged 10 to 12 years, Hebrew speaking and healthy.
- Hebrew speaking parents.
Key exclusion criteria (2 listed)
- Teenagers suffering from chronic diseases of diseases that leads to learning disabilities.
- Teenagers who live in homes without exposure to electronical media.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meetings guides by experts in sleeping disorders.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. | Other | Experimental group |
Primary outcome
Sleep Habits
Time frame: Two years
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.
2 secondary outcomes
Parents Knowledge regarding Sleep and Media
Time frame: Two Years
Quantity of media exposure
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel Koren, MD principal investigator
HaEmek Medical Center - Afula - IsRAEL
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meetings guides by experts in sleeping disorders. in people with Sleep, run by HaEmek Medical Center, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Habits (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.