Sleep DisorderNCT01489215
Interventions for Sleep Problems in Early Childhood
A study testing "presence" and "checking" in people with Sleep Disorder, run by Tel-Aviv Sourasky Medical Center.
Trial summary
This study will inform the field about underlying mechanisms associated with infant sleep problems and will deepen the understanding of the intervention process. The study will provide detailed information on the intervention process itself and will explore how behavioral sleep interventions affect broader infant… Read more about this study
- Who is it for?
- Ages 9 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- "presence" and "checking"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Feb 2015
- Phase
- Interventional
- 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 9 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- infants at age range 9-18 months;
- healthy infants with no significant health problems;
- two-parents families;
- parents who master the Hebrew language.
- significant sleep problem lasting more than 3 months:
- Our definition for a significant sleep problem in this age range is based on meeting at least one of the following three criteria for the baseline week:
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- an average of three or more night-wakings per night;
- an average wake period of at least 30 minute per night between sleep onset and morning rise time;
- more than 30 minutes to fall asleep each night with protests for attention.
Who cannot join
- Infants not meeting the inclusion criteria at the baseline assessment will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Interventions for Sleep Problems in Early Childhood:The Role of Child, Parental and Intervention Factors
This study will inform the field about underlying mechanisms associated with infant sleep problems and will deepen the understanding of the intervention process. The study will provide detailed information on the intervention process itself and will explore how behavioral sleep interventions affect broader infant outcome.
- Conditions
- Sleep Disorder
- Being tested
- "presence", "checking"
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"presence"Behavioural
constant presence of the parent in the child's room throughout the night during the first week of the intervention. In addition to sleeping near the child's crib, the parents repeat the same routines as in the "checking" method if the child is actively protesting or crying.
"checking"Behavioural
putting the child into the crib at bedtime and leaving the room with repeated quick visits every 5 minutes if the child is actively protesting or crying, providing brief reassurance, helping the child to resume a sleeping position.
| Study group | Role | What they receive |
|---|---|---|
| Clinical group-"presence" intervention | Experimental | The "Presence" intervention is based on based on the principles of graduated extinction, which has been defined has been defined as "effective and recommended therapy in the treatment of bedtime problems and night wakings" by the Standard of Practice Committee of the American Academy of Sleep Medicine. Receives: Behavioral: "presence" |
| Clinical group-"checking" intervention | Experimental | The "Checking" training is based on the principles of graduated extinction, which has been defined has been defined as "effective and recommended therapy in the treatment of bedtime problems and night wakings" by the Standard of Practice Committee of the American Academy of Sleep Medicine Receives: Behavioral: "checking" |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved infant sleep
Less parental involvement in falling asleep, less night wakings, heightened sleep efficacy
Measured: base line to one month follow-up
Secondary outcomes (1)
improvement in infant emotion regulation and in parent-infant interaction
infant heightened ability to regulate emotion when frustrated, a more secure infant attachment to mother, less infant withdrawal and more maternal sensitivity
Measured: one month follow-up to one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Israel Science Foundation, U.S. National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Yakov Sivan, Prof., Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489215
- Sponsor's protocol ID
- TASMC-11-YS-0522-CTIL
- Status last verified
- Dec 2011
- First submitted
- 8 Dec 2011
- Last updated
- 9 Dec 2011
- Results posted
- No
Publications
Kahn M, Livne-Karp E, Juda-Hanael M, Omer H, Tikotzky L, Anders TF, Sadeh A. Behavioral interventions for infant sleep problems: the role of parental cry tolerance and sleep-related cognitions. J Clin Sleep Med. 2020 Aug 15;16(8):1275-1283. doi: 10.5664/jcsm.8488.
PubMed 32279703Kahn M, Juda-Hanael M, Livne-Karp E, Tikotzky L, Anders TF, Sadeh A. Behavioral interventions for pediatric insomnia: one treatment may not fit all. Sleep. 2020 Apr 15;43(4):zsz268. doi: 10.1093/sleep/zsz268.
PubMed 31676910
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions for Sleep Problems in Early Childhood:The Role of Child, Parental and Intervention Factors
- ClinicalTrials.gov ID
- NCT01489215
- Acronym / sponsor ID
- TASMC-11-YS-0522-CTIL
- Conditions
- Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Israel Science Foundation, U.S. National Science Foundation
- Study start
- Feb 2012
- Primary completion
- Feb 2015 (estimated)
- First posted
- 9 Dec 2011 (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.
This study will inform the field about underlying mechanisms associated with infant sleep problems and will deepen the understanding of the intervention process. The study will provide detailed information on the intervention process itself and will explore how behavioral sleep interventions affect broader infant outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical group-"presence" intervention | Experimental | Behavioral: "presence"The "Presence" intervention is based on based on the principles of graduated extinction, which has been defined has been defined as "effective and recommended therapy in the treatment of bedtime problems and night wakings" by the Standard of Practice Committee of the American Academy of Sleep Medicine. |
| Clinical group-"checking" intervention | Experimental | Behavioral: "checking"The "Checking" training is based on the principles of graduated extinction, which has been defined has been defined as "effective and recommended therapy in the treatment of bedtime problems and night wakings" by the Standard of Practice Committee of the American Academy of Sleep Medicine |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 9 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- infants at age range 9-18 months;
- healthy infants with no significant health problems;
- two-parents families;
- parents who master the Hebrew language.
- significant sleep problem lasting more than 3 months:
Key exclusion criteria (1 listed)
- Infants not meeting the inclusion criteria at the baseline assessment will be excluded from the study.
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 |
|---|---|---|
| "presence"constant presence of the parent in the child's room throughout the night during the first week of the intervention. In addition to sleeping near the child's crib, the parents repeat the same routines as in the "checking" method if the child is actively protesting or crying. | Behavioural | Clinical group-"presence" intervention |
| "checking"putting the child into the crib at bedtime and leaving the room with repeated quick visits every 5 minutes if the child is actively protesting or crying, providing brief reassurance, helping the child to resume a sleeping position. | Behavioural | Clinical group-"checking" intervention |
Primary outcome
Improved infant sleep
Time frame: base line to one month follow-up
Less parental involvement in falling asleep, less night wakings, heightened sleep efficacy
1 secondary outcome
improvement in infant emotion regulation and in parent-infant interaction
Time frame: one month follow-up to one year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2011.
- Derived from this study: PubMed 32279703Kahn M, Livne-Karp E, Juda-Hanael M, Omer H, Tikotzky L, Anders TF, Sadeh A. Behavioral interventions for infant sleep problems: the role of parental cry tolerance and sleep-related cognitions. J Clin Sleep Med. 2020 Aug 15;16(8):1275-1283. doi: 10.5664/jcsm.8488.
- Derived from this study: PubMed 31676910Kahn M, Juda-Hanael M, Livne-Karp E, Tikotzky L, Anders TF, Sadeh A. Behavioral interventions for pediatric insomnia: one treatment may not fit all. Sleep. 2020 Apr 15;43(4):zsz268. doi: 10.1093/sleep/zsz268.
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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.
Yakov Sivan, Prof. principal investigator
Tel-Aviv Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing "presence" and "checking" in people with Sleep Disorder, run by Tel-Aviv Sourasky Medical Center.
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 9 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Dec 2011. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avi Sadeh, Prof. (03-6409296, sadeh@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved infant sleep (time frame: base line to one month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01489215, which also lists 2 linked publications.
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 9 Dec 2011.