InsomniaNCT02783560
Behavioral Sleep Intervention in Children With Disruptive Behaviors
A study testing The Sleep Train Program and The Family Mealtimes Program in people with Insomnia and Disruptive Behavior Disorder, run by Indiana University.
Trial summary
Despite the high prevalence of sleep difficulties in children with disruptive behavior disorders, little is known about the role of sleep in treating disruptive behavior. The current study evaluates the addition of a sleep intervention to an existing parent-training program for caregivers of children ages 3-8 with… Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Insomnia, Disruptive Behavior Disorder, Oppositional Defiant Disorder
- What is being tested?
- The Sleep Train Program and The Family Mealtimes Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Sep 2020
- 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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Caregiver participating in treatment lives at home with the child at least 50% of the time
- Child has an Eyberg Problem or Intensity T score of 60 or greater OR an Achenbach score of 60 or greater on the Externalizing scale
Who cannot join
- Child is working with another therapist or provider to address either sleep or disruptive behaviors
- Child is taking medications known to impact sleep
- Child has symptoms of obstructive sleep apnea (OSA) and OSA has not been ruled out via a sleep study
- Child has a sibling who is already participating in the study
- Child has been diagnosed with an autism spectrum disorder
About this study
Official title: The Role of Sleep in Addressing Disruptive Behavior in Children
Despite the high prevalence of sleep difficulties in children with disruptive behavior disorders, little is known about the role of sleep in treating disruptive behavior. The current study evaluates the addition of a sleep intervention to an existing parent-training program for caregivers of children ages 3-8 with disruptive behaviors. Objectives are to examine the impact of a novel sleep treatment program on sleep, disruptive behavior, and other measures of family functioning, utilizing a variety of self-report and objective measures (e.g. actigraphy, electrodermal activity). The investigators hypothesize that sleep intervention will result in improvements in sleep and disruptive behavior compared to control group receiving a highly plausible addition to the standard parent training intervention, and that sleep outcomes will moderate overall treatment success.
Read the detailed description
Overview: The current study, which is a collaboration between Indiana University at Bloomington (PI: Bates) and Indiana University School of Medicine (PI: Honaker), seeks to evaluate the impact of adding a sleep component to a parenting intervention that has been shown to effectively treat disruptive behavior in children. A mealtime intervention will serve as an active control for the sleep treatment component, as the mealtime intervention targets changes in a family routine but is unlikely to significantly impact sleep. Participants who receive the sleep component are expected to show significant improvements in sleep compared to the mealtime group. The investigators further hypothesize that children receiving the sleep intervention will have reduced presleep arousal levels compared to baseline, and will show greater reduction in presleep arousal levels than the mealtime/control group. Finally, because of the documented links between poor sleep and externalizing behavior problems and theoretical arguments about sleep mechanisms supporting emotional and behavioral self-regulation, the investigators hypothesize that the participants who receive the sleep component will show greater reductions in disruptive behavior compared to the mealtime/control group.
Participants and Design: Participants are 3-8-year-old children who exhibit disruptive behaviors and their parents. Participants meeting criteria for the parent-training program offered as part of the general clinic practice would be approached by the therapist to discuss participation in the study. Following the consent procedure, they would be randomly assigned to one of two groups. The sleep intervention group would receive a brief, novel sleep intervention (The Sleep Train Program) in the context of the parenting program's Setting Up for Success segment, which focuses on positive routines. Sleep would be addressed briefly as needed in subsequent sessions. The mealtime/control group would not receive any particular intervention or guidance regarding sleep, but would instead focus on the routine of mealtimes. All families would then receive the same core intervention for disruptive behavior. Following the completion of the data collection, families who received the sleep component would receive the mealtime component, and vice versa.
Interventions: The existing parenting skills intervention is largely built on Troubled Families: A Treatment Program, a manualized treatment approach with extensive empirical support, selected as it is currently delivered by clinical psychology trainees at the Psychological Clinic at Indiana University in Bloomington. The sleep intervention and control intervention focusing on mealtime structure have been designed to be parallel in terms of structure and length. Though neither intervention has been evaluated (both were developed for this study), both incorporate treatment strategies with an empirical basis. The sleep intervention focuses on sufficient sleep, healthy sleep habits, and a positive bedtime routine, with optional modules to help address bedtime problems, night wakings, fears, anxiety, and independent sleep. The mealtime intervention focuses on healthy mealtime habits and mealtime routines, with optional modules to address picky eating and disruptive mealtime behaviors.
Data collection and measures: Some data will be recorded daily throughout the study, including parent diary measures of child sleep and the main child misbehaviors (noncompliance, tantrums, aggression). Other data will be collected in 4 major assessments periods. The baseline assessment will occur at the end of the initial assessment with the family and prior to the first treatment session. The midpoint assessment will occur prior to the start of the discipline intervention, approximately six week after the start of treatment. This assessment period allows for evaluation of disruptive behavior and sleep following the sleep component and an introductory segment (Setting Up for Success), but prior to the initiation of the core disruptive behavior / parenting intervention. In other words, any improvements in disruptive behavior could be attributed largely to the sleep or mealtime addition rather than the core parenting intervention. The second midpoint assessment will occur following the core intervention, but prior to initiating the sleep/mealtime component not previously covered. This allows for the evaluation of the combined sleep and disruptive behavior interventions, as well as a comparison in treatment outcomes for those who received the sleep component and those who received the mealtime/control component. A final assessment will occur following the conclusion of treatment. Survey data will be collected using on-line forms created in REDCap, and completed on a tablet that will be loaned to the family.
Measures were selected to assess sleep, disruptive behavior, child daytime functioning more generally, and family functioning. An actigraph is worn by the child for one week during each of the four assessment periods, with interpretation aided by the accompanying sleep diary. An Empatica E3 device will be used to assess electro dermal activity (EDA) as a measure of presleep arousal. The child will be asked to wear this device each evening from the start of the bedtime routine through sleep onset, at which point the parent is asked to remove the device.
Individuals collaborating on this study include: John Bates PhD (co-PI), Indiana University at Bloomington; Amy Williams PhD, Indiana University School of Medicine, and several graduate students at Indiana University in Bloomington, specifically Maureen McQuillan, Caroline Hoyniak, Brittany Rudd, and Kyle Gerst.
- Being tested
- The Sleep Train Program, The Family Mealtimes Program
- Keywords
- Sleep, Electrodermal Activity, Mealtimes
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Attention Deficit and Disruptive Behavior Disorders, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Sleep Train ProgramBehavioural
This modular behavioral sleep intervention includes required modules on sleep routines and sleep habits, and optional modules on bedtime problems, fears, anxiety, and independent sleep.
The Family Mealtimes ProgramBehavioural
This modular behavioral mealtime intervention includes required modules on mealtime routines and healthy mealtime habits, and optional modules on picky eating and mealtime behavior difficulties.
| Study group | Role | What they receive |
|---|---|---|
| Sleep First | Experimental | Families in this condition will receive a behavioral sleep intervention program (The Sleep Train Program) first, prior to a parent training intervention for disruptive behavior. After the completion of the parent training program and several assessment periods, families will receive the mealtime intervention (The Family Mealtimes Program). Receives: Behavioral: The Sleep Train Program; Behavioral: The Family Mealtimes Program |
| Mealtimes First | Active comparator | Families in this active comparison condition will receive a behavioral treatment to promote positive family mealtimes first, prior to a parent training intervention for disruptive behavior. After the completion of the parent training program and several assessment periods, families will receive a behavioral sleep intervention (The Sleep Train Program). Receives: Behavioral: The Sleep Train Program; Behavioral: The Family Mealtimes Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Externalizing Symptoms (after sleep or control/mealtime intervention)
Eyberg Child Behavior Inventory, Intensity Score
Measured: Change from baseline (first visit) to midpoint 1 (after sleep or mealtime intervention, approximately 6 weeks after visit 1).
Secondary outcomes (9)
Objective Estimate of Child Sleep Patterns (after sleep or control/mealtime intervention)
Actigraphy, worn by child for 1 week at each time point
Measured: Change from baseline (first visit) to midpoint 1 (after sleep or mealtime intervention, approximately 6 weeks after visit 1).
Objective Estimate of Child Sleep Patterns (after sleep or control/mealtime intervention + parent training)
Actigraphy, worn by child for 1 week at each time point
Measured: Change from baseline (first visit) to midpoint 2 (after parent training but before crossover, approximately 12-14 weeks after baseline)
Objective Estimate of Child Sleep Patterns (before and after sleep intervention; pre/post)
Actigraphy, worn by child for 1 week at each time point
Measured: Change from baseline (first visit) to midpoint 1 (after sleep, approximately six weeks after visit 1) for the sleep condition and midpoint 2 to final (approximately six week after midpoint 2) for the mealtime condition.
Subjective Report of Child Sleep Patterns (after sleep or control/mealtime intervention)
Composite of two subscales ("Going to Bed" and "Falling Asleep") from the Children's Sleep Wake Scale
Measured: Change from baseline (first visit) to midpoint 1 (after sleep/mealtime intervention, approximately 6 weeks after visit 1).
Subjective Report of Child Sleep Patterns (after sleep or control/mealtime intervention + parent training)
Composite of two subscales ("Going to Bed" and "Falling Asleep") from the Children's Sleep Wake Scale
Measured: Change from baseline (first visit) to midpoint 2 (after parent training but before crossover, approximately 12-14 weeks after baseline)
Subjective Report of Child Sleep Patterns (before and after sleep intervention; pre/post)
Composite of two subscales ("Going to Bed" and "Falling Asleep") from the Children's Sleep Wake Scale
Measured: Change from baseline (first visit) to midpoint 1 (after sleep, approximately six weeks after visit 1) for the sleep condition and midpoint 2 to final (approximately six week after midpoint 2) for the mealtime condition.
Child Externalizing Symptoms (after sleep or control/mealtime intervention + parent training)
Eyberg Child Behavior Inventory, Intensity Score
Measured: Change from baseline (first visit) to midpoint 2 (after parent training but before crossover, approximately 12-14 weeks after baseline)
Parental Sleep (after sleep or control/mealtime intervention)
Actigraphy, worn by parent for 1 week at each time point
Measured: Change from baseline (first visit) to final (appoximately 3 months after visit 1).
Parental Stress (before and after sleep intervention; pre/post)
Parenting Stress Index Short Form (PSI-4-SF)
Measured: Change from baseline (first visit) to midpoint 1 (after sleep, approximately 6 weeks after visit 1) for the sleep condition and midpoint 2 to final (approximately six week after midpoint 2) for the mealtime condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2019
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Honaker, Indiana University
- Investigators
- Sarah M Honaker, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783560
- Sponsor's protocol ID
- 2286108
- Other IDs
- UL1TR001108
- Status last verified
- Aug 2022
- First submitted
- 17 May 2016
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
McQuillan ME, Bates JE, Hoyniak CP, Staples AD, Honaker SM. Children's Sleep and Externalizing Problems: A Day-to-day Multilevel Modeling Approach. Behav Sleep Med. 2023 Nov 2;21(6):712-726. doi: 10.1080/15402002.2022.2156510. Epub 2022 Dec 13.
PubMed 36514294
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sleep in Addressing Disruptive Behavior in Children
- ClinicalTrials.gov ID
- NCT02783560
- Acronym / sponsor ID
- 2286108
- Keywords
- Sleep, Electrodermal Activity, Mealtimes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 26 May 2016 (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.
Despite the high prevalence of sleep difficulties in children with disruptive behavior disorders, little is known about the role of sleep in treating disruptive behavior. The current study evaluates the addition of a sleep intervention to an existing parent-training program for caregivers of children ages 3-8 with disruptive behaviors. Objectives are to examine the impact of a novel sleep treatment program on sleep, disruptive behavior, and other measures of family functioning, utilizing a variety of self-report and objective measures (e.g. actigraphy, electrodermal activity). The investigators hypothesize that sleep intervention will result in improvements in sleep and disruptive behavior compared to control group receiving a highly plausible addition to the standard parent training intervention, and that sleep outcomes will moderate overall treatment success.
Detailed description
Overview: The current study, which is a collaboration between Indiana University at Bloomington (PI: Bates) and Indiana University School of Medicine (PI: Honaker), seeks to evaluate the impact of adding a sleep component to a parenting intervention that has been shown to effectively treat disruptive behavior in children. A mealtime intervention will serve as an active control for the sleep treatment component, as the mealtime intervention targets changes in a family routine but is unlikely to significantly impact sleep. Participants who receive the sleep component are expected to show significant improvements in sleep compared to the mealtime group. The investigators further hypothesize that children receiving the sleep intervention will have reduced presleep arousal levels compared to baseline, and will show greater reduction in presleep arousal levels than the mealtime/control group. Finally, because of the documented links between poor sleep and externalizing behavior problems and theoretical arguments about sleep mechanisms supporting emotional and behavioral self-regulation, the investigators hypothesize that the participants who receive the sleep component will show greater reductions in disruptive behavior compared to the mealtime/control group.
Participants and Design: Participants are 3-8-year-old children who exhibit disruptive behaviors and their parents. Participants meeting criteria for the parent-training program offered as part of the general clinic practice would be approached by the therapist to discuss participation in the study. Following the consent procedure, they would be randomly assigned to one of two groups. The sleep intervention group would receive a brief, novel sleep intervention (The Sleep Train Program) in the context of the parenting program's Setting Up for Success segment, which focuses on positive routines. Sleep would be addressed briefly as needed in subsequent sessions. The mealtime/control group would not receive any particular intervention or guidance regarding sleep, but would instead focus on the routine of mealtimes. All families would then receive the same core intervention for disruptive behavior. Following the completion of the data collection, families who received the sleep component would receive the mealtime component, and vice versa.
Interventions: The existing parenting skills intervention is largely built on Troubled Families: A Treatment Program, a manualized treatment approach with extensive empirical support, selected as it is currently delivered by clinical psychology trainees at the Psychological Clinic at Indiana University in Bloomington. The sleep intervention and control intervention focusing on mealtime structure have been designed to be parallel in terms of structure and length. Though neither intervention has been evaluated (both were developed for this study), both incorporate treatment strategies with an empirical basis. The sleep intervention focuses on sufficient sleep, healthy sleep habits, and a positive bedtime routine, with optional modules to help address bedtime problems, night wakings, fears, anxiety, and independent sleep. The mealtime intervention focuses on healthy mealtime habits and mealtime routines, with optional modules to address picky eating and disruptive mealtime behaviors.
Data collection and measures: Some data will be recorded daily throughout the study, including parent diary measures of child sleep and the main child misbehaviors (noncompliance, tantrums, aggression). Other data will be collected in 4 major assessments periods. The baseline assessment will occur at the end of the initial assessment with the family and prior to the first treatment session. The midpoint assessment will occur prior to the start of the discipline intervention, approximately six week after the start of treatment. This assessment period allows for evaluation of disruptive behavior and sleep following the sleep component and an introductory segment (Setting Up for Success), but prior to the initiation of the core disruptive behavior / parenting intervention. In other words, any improvements in disruptive behavior could be attributed largely to the sleep or mealtime addition rather than the core parenting intervention. The second midpoint assessment will occur following the core intervention, but prior to initiating the sleep/mealtime component not previously covered. This allows for the evaluation of the combined sleep and disruptive behavior interventions, as well as a comparison in treatment outcomes for those who received the sleep component and those who received the mealtime/control component. A final assessment will occur following the conclusion of treatment. Survey data will be collected using on-line forms created in REDCap, and completed on a tablet that will be loaned to the family.
Measures were selected to assess sleep, disruptive behavior, child daytime functioning more generally, and family functioning. An actigraph is worn by the child for one week during each of the four assessment periods, with interpretation aided by the accompanying sleep diary. An Empatica E3 device will be used to assess electro dermal activity (EDA) as a measure of presleep arousal. The child will be asked to wear this device each evening from the start of the bedtime routine through sleep onset, at which point the parent is asked to remove the device.
Individuals collaborating on this study include: John Bates PhD (co-PI), Indiana University at Bloomington; Amy Williams PhD, Indiana University School of Medicine, and several graduate students at Indiana University in Bloomington, specifically Maureen McQuillan, Caroline Hoyniak, Brittany Rudd, and Kyle Gerst.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep First | Experimental | Behavioral: The Sleep Train Program, Behavioral: The Family Mealtimes ProgramFamilies in this condition will receive a behavioral sleep intervention program (The Sleep Train Program) first, prior to a parent training intervention for disruptive behavior. After the completion of the parent training program and several assessment periods, families will receive the mealtime intervention (The Family Mealtimes Program). |
| Mealtimes First | Active comparator | Behavioral: The Sleep Train Program, Behavioral: The Family Mealtimes ProgramFamilies in this active comparison condition will receive a behavioral treatment to promote positive family mealtimes first, prior to a parent training intervention for disruptive behavior. After the completion of the parent training program and several assessment periods, families will receive a behavioral sleep intervention (The Sleep Train Program). |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Caregiver participating in treatment lives at home with the child at least 50% of the time
- Child has an Eyberg Problem or Intensity T score of 60 or greater OR an Achenbach score of 60 or greater on the Externalizing scale
Key exclusion criteria (5 listed)
- Child is working with another therapist or provider to address either sleep or disruptive behaviors
- Child is taking medications known to impact sleep
- Child has symptoms of obstructive sleep apnea (OSA) and OSA has not been ruled out via a sleep study
- Child has a sibling who is already participating in the study
- Child has been diagnosed with an autism spectrum disorder
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 |
|---|---|---|
| The Sleep Train ProgramThis modular behavioral sleep intervention includes required modules on sleep routines and sleep habits, and optional modules on bedtime problems, fears, anxiety, and independent sleep. | Behavioural | Mealtimes First, Sleep First |
| The Family Mealtimes ProgramThis modular behavioral mealtime intervention includes required modules on mealtime routines and healthy mealtime habits, and optional modules on picky eating and mealtime behavior difficulties. | Behavioural | Mealtimes First, Sleep First |
Primary outcome
Child Externalizing Symptoms (after sleep or control/mealtime intervention)
Time frame: Change from baseline (first visit) to midpoint 1 (after sleep or mealtime intervention, approximately 6 weeks after visit 1).
Eyberg Child Behavior Inventory, Intensity Score
9 secondary outcomes
Objective Estimate of Child Sleep Patterns (after sleep or control/mealtime intervention)
Time frame: Change from baseline (first visit) to midpoint 1 (after sleep or mealtime intervention, approximately 6 weeks after visit 1).
Objective Estimate of Child Sleep Patterns (after sleep or control/mealtime intervention + parent training)
Time frame: Change from baseline (first visit) to midpoint 2 (after parent training but before crossover, approximately 12-14 weeks after baseline)
Objective Estimate of Child Sleep Patterns (before and after sleep intervention; pre/post)
Time frame: Change from baseline (first visit) to midpoint 1 (after sleep, approximately six weeks after visit 1) for the sleep condition and midpoint 2 to final (approximately six week after midpoint 2) for the mealtime condition.
Subjective Report of Child Sleep Patterns (after sleep or control/mealtime intervention)
Time frame: Change from baseline (first visit) to midpoint 1 (after sleep/mealtime intervention, approximately 6 weeks after visit 1).
Subjective Report of Child Sleep Patterns (after sleep or control/mealtime intervention + parent training)
Time frame: Change from baseline (first visit) to midpoint 2 (after parent training but before crossover, approximately 12-14 weeks after baseline)
Subjective Report of Child Sleep Patterns (before and after sleep intervention; pre/post)
Time frame: Change from baseline (first visit) to midpoint 1 (after sleep, approximately six weeks after visit 1) for the sleep condition and midpoint 2 to final (approximately six week after midpoint 2) for the mealtime condition.
Child Externalizing Symptoms (after sleep or control/mealtime intervention + parent training)
Time frame: Change from baseline (first visit) to midpoint 2 (after parent training but before crossover, approximately 12-14 weeks after baseline)
Parental Sleep (after sleep or control/mealtime intervention)
Time frame: Change from baseline (first visit) to final (appoximately 3 months after visit 1).
Parental Stress (before and after sleep intervention; pre/post)
Time frame: Change from baseline (first visit) to midpoint 1 (after sleep, approximately 6 weeks after visit 1) for the sleep condition and midpoint 2 to final (approximately six week after midpoint 2) for the mealtime condition.
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 19 Aug 2022.
- Derived from this study: PubMed 36514294McQuillan ME, Bates JE, Hoyniak CP, Staples AD, Honaker SM. Children's Sleep and Externalizing Problems: A Day-to-day Multilevel Modeling Approach. Behav Sleep Med. 2023 Nov 2;21(6):712-726. doi: 10.1080/15402002.2022.2156510. Epub 2022 Dec 13.
- Individual participant dataSharing planned: No
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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.
Sarah M Honaker, PhD principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A study testing The Sleep Train Program and The Family Mealtimes Program in people with Insomnia and Disruptive Behavior Disorder, run by Indiana University.
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 5 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 19 Aug 2022. 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?
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?
Child Externalizing Symptoms (after sleep or control/mealtime intervention) (time frame: Change from baseline (first visit) to midpoint 1 (after sleep or mealtime intervention, approximately 6 weeks after visit 1).). 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 NCT02783560, which also lists 1 linked publication.
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 19 Aug 2022.