Sleep DeprivationNCT03926221
Parent-Adolescent Interpersonal Processes in the Science of Behavior Change
A study testing Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C) in people with Sleep Deprivation and Adolescent Behavior, run by University of California, Berkeley at 1 site in United States.
Trial summary
This study seeks to examine a novel interpersonal target; namely, parent-teen conversations about youth health behavior change. The rationale is that parents have profound impacts on teen risk and vulnerability. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Adolescent Behavior
- What is being tested?
- Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 26 Aug 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 10 and 18 and living with a parent or guardian
- Lowest quartile of the widely used and well-validated Children's Morningness-Eveningness Preferences Scale (CMEP; 27 or lower) and
- Youth self-reported weekday sleep onset time for the past month later than 10:40 pm for 10- to 13-year- olds; 11:00pm for 14-16 year olds, and later than 11:20 for 17-18 year olds at least 3 nights per week;
- English language fluency;
- able and willing to give informed assent;
- at least one parent/primary caregiver who lives in the same household as the teen for at least 50% of the week must participate in all study sessions.
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- Age between 10 and 18 and living with a parent or guardian
- (CMEP; 28 or higher) on Children's Morningness-Eveningness Preferences Scale
- Item #6 on the Pittsburgh Sleep Quality Index (PSQI) rated 'fairly' or 'very good'
- English language fluency;
- able and willing to give informed assent;
- at least one parent/primary caregiver who lives in the same household as the teen for at least 50% of the week must participate in all study sessions.
Who cannot join
- An active, progressive physical illness directly related to the onset and course of the sleep disturbance;
- evidence of sleep apnea, restless legs or periodic limb movements;
- significantly impairing pervasive developmental disorder;
- history of substance dependence in the past six months;
- suicide risk; bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study;
- Participants will not be excluded if medications are stable (> 4 weeks).
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- An active, progressive physical illness directly related to the onset and course of the sleep disturbance;
- evidence of sleep apnea, restless legs or periodic limb movements;
- significantly impairing pervasive developmental disorder;
- history of substance dependence in the past six months;
- suicide risk; bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study;
- Participants will not be excluded if medications are stable (> 4 weeks).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720-1650
About this study
This study seeks to examine a novel interpersonal target; namely, parent-teen conversations about youth health behavior change. The rationale is that parents have profound impacts on teen risk and vulnerability. Yet parents receive minimal training in the elements of conversations that optimally inspire their children toward engaging in healthy behaviors. A theoretically grounded and reliable taxonomy of behavior change techniques (BCTs) will be used as a basis for scientifically deriving the conversational elements, or micro-mechanisms, that reduce parent-teen conflict and facilitate upward spirals of healthful behavior change. This proposal builds on pilot data from a recently completed NICHD-funded R01 in which a sleep treatment improved sleep and reduced risk on selected outcomes in youth. While sleep-related health behaviors will be the focus of this R21, the research is designed to be relevant to a broad range of health behavior change. As part of an Administrative Supplement to the R21 awarded in Fall, 2019, two changes are made. First, measures of psychophysiology have been added to the Hot Topics Task. Second, an independent sample of teens who are healthy sleepers (n = 20), and their parents, will be tested on the protocol twice, 9 weeks apart. This comparison group is included to control for the passage of time and for completing the protocol twice. They do not receive an intervention.
- Conditions
- Sleep Deprivation, Adolescent Behavior
- Being tested
- Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)
- Medical subject headings
- Sleep Deprivation, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)Behavioural
PBC-I will be administered to the parent and TranS-C will be administered to the teenager. Both interventions are cognitive-behavioral and comprised of six weekly sessions. Parent and teenager sessions will be held in parallel.
| Study group | Role | What they receive |
|---|---|---|
| PBC_I plus TranS-C | Experimental | The Parent Behavior Change Intervention (PBC-I) is a behavioral intervention intended to teach parent behavior change techniques to better support their adolescents to improve sleep health behavior. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature. Receives: Behavioral: Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of BCTs used by parent coded from the Hot Topics Task
Parent measure.
Measured: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Parent perception of general conflict between parent and child measured via Conflict Behavior Questionnaire
Parent measure. 20 items each on a true/false scale. Total score ranges from 0 to 20 and is computed by adding up total score points. Higher scores indicate more general conflict.
Measured: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Decisional balance proportion
Measured by Decision Balance Worksheet. Youth measure.
Measured: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Subjective sleep quality measured via Pittsburgh Sleep Quality Index global score
Youth measure. 19 items each on a 4-point scale. Global score ranges from 0 to 21 and is computed by totaling seven component scores. Lower scores indicate healthier sleep quality.
Measured: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Secondary outcomes (7)
Type of BCTs used by parent coded from the Hot Topics Task
Parent measure.
Measured: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Number of negative and positive communication behaviors coded from the Hot Topics Task
Parent measure.
Measured: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's perception of general conflict between parent and child measured via Conflict Behavior Questionnaire.
Youth measure. 20 items each on a true/false scale. Total score ranges from 0 to 20 and is computed by adding up total score points. Higher scores indicate more general conflict.
Measured: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth self-reported motivation of participating in TranS-C/making sleep behavior changes via the Intrinsic Motivation Questionnaire
Youth measure. 18 items on a 7-point Likert scale, with three subscales being used: Interest/Enjoyment, Perceived Competence, and Effort/Importance. Total score ranges from 3 to 21 (1-7 for each subscale score) and is computed by averaging items within each subscale and adding the 3 subscale scores.
Measured: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Regularity in sleep midpoint across the week measured via daily sleep diary
Youth measure.
Measured: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Regularity in sleep midpoint across the week measured via actigraphy
Youth measure.
Measured: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Morningness/eveningness preference measured via Children's Morningness Eveningness Preference Scale
Youth measure. 10 items are weighed on either 4- or 5-point scales. Total score ranges from 10 to 43 and is computed by adding up total points. Scores between 10 and 20 indicate eveningness, scores between 28 and 42 indicate morningness, scores between 21 and 27 are categorized as neither.
Measured: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Dec 2018
- Primary completion11 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Allison Harvey, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926221
- Sponsor's protocol ID
- R21_parent_teen_study
- Other IDs
- R21HD097819
- Status last verified
- Nov 2020
- First submitted
- 4 Apr 2019
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Adolescent Interpersonal Processes in the Science of Behavior Change
- ClinicalTrials.gov ID
- NCT03926221
- Acronym / sponsor ID
- R21_parent_teen_study
- Conditions
- Sleep Deprivation, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 11 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 24 Apr 2019 (actual)
- 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 seeks to examine a novel interpersonal target; namely, parent-teen conversations about youth health behavior change. The rationale is that parents have profound impacts on teen risk and vulnerability. Yet parents receive minimal training in the elements of conversations that optimally inspire their children toward engaging in healthy behaviors. A theoretically grounded and reliable taxonomy of behavior change techniques (BCTs) will be used as a basis for scientifically deriving the conversational elements, or micro-mechanisms, that reduce parent-teen conflict and facilitate upward spirals of healthful behavior change. This proposal builds on pilot data from a recently completed NICHD-funded R01 in which a sleep treatment improved sleep and reduced risk on selected outcomes in youth. While sleep-related health behaviors will be the focus of this R21, the research is designed to be relevant to a broad range of health behavior change. As part of an Administrative Supplement to the R21 awarded in Fall, 2019, two changes are made. First, measures of psychophysiology have been added to the Hot Topics Task. Second, an independent sample of teens who are healthy sleepers (n = 20), and their parents, will be tested on the protocol twice, 9 weeks apart. This comparison group is included to control for the passage of time and for completing the protocol twice. They do not receive an intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PBC_I plus TranS-C | Experimental | Behavioral: Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)The Parent Behavior Change Intervention (PBC-I) is a behavioral intervention intended to teach parent behavior change techniques to better support their adolescents to improve sleep health behavior. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Age between 10 and 18 and living with a parent or guardian
- Lowest quartile of the widely used and well-validated Children's Morningness-Eveningness Preferences Scale (CMEP; 27 or lower) and
- Youth self-reported weekday sleep onset time for the past month later than 10:40 pm for 10- to 13-year- olds; 11:00pm for 14-16 year olds, and later than 11:20 for 17-18 year olds at least 3 nights per week;
- English language fluency;
- able and willing to give informed assent;
Key exclusion criteria (12 listed)
- An active, progressive physical illness directly related to the onset and course of the sleep disturbance;
- evidence of sleep apnea, restless legs or periodic limb movements;
- significantly impairing pervasive developmental disorder;
- history of substance dependence in the past six months;
- suicide risk; bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this 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 |
|---|---|---|
| Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)PBC-I will be administered to the parent and TranS-C will be administered to the teenager. Both interventions are cognitive-behavioral and comprised of six weekly sessions. Parent and teenager sessions will be held in parallel. | Behavioural | PBC_I plus TranS-C |
Primary outcome
Number of BCTs used by parent coded from the Hot Topics Task
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Parent measure.
Parent perception of general conflict between parent and child measured via Conflict Behavior Questionnaire
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Parent measure. 20 items each on a true/false scale. Total score ranges from 0 to 20 and is computed by adding up total score points. Higher scores indicate more general conflict.
Decisional balance proportion
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Measured by Decision Balance Worksheet. Youth measure.
Subjective sleep quality measured via Pittsburgh Sleep Quality Index global score
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth measure. 19 items each on a 4-point scale. Global score ranges from 0 to 21 and is computed by totaling seven component scores. Lower scores indicate healthier sleep quality.
7 secondary outcomes
Type of BCTs used by parent coded from the Hot Topics Task
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Number of negative and positive communication behaviors coded from the Hot Topics Task
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth's perception of general conflict between parent and child measured via Conflict Behavior Questionnaire.
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Youth self-reported motivation of participating in TranS-C/making sleep behavior changes via the Intrinsic Motivation Questionnaire
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Regularity in sleep midpoint across the week measured via daily sleep diary
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Regularity in sleep midpoint across the week measured via actigraphy
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
Morningness/eveningness preference measured via Children's Morningness Eveningness Preference Scale
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
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 5 Nov 2020.
- 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.
Allison Harvey, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C) in people with Sleep Deprivation and Adolescent Behavior, run by University of California, Berkeley at 1 site in United States.
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 12 inclusion and 12 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 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of BCTs used by parent coded from the Hot Topics Task (time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment). The study lists 4 primary outcomes in all. 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 5 Nov 2020.