Parent-Adolescent Interpersonal Processes in the Science of Behavior Change
2020年11月3日 更新者：University of California, Berkeley
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.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
112
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
California
-
Berkeley、California、アメリカ、94720-1650
- University of California, Berkeley
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
10年～18年 (子、大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Inclusion criteria (control group):
- 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.
Exclusion Criteria (control group)
- 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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：PBC_I plus 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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of BCTs used by parent coded from the Hot Topics Task
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
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Parent measure.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Parent perception of general conflict between parent and child measured via Conflict Behavior Questionnaire
時間枠：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.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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Decisional balance proportion
時間枠：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.
|
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
時間枠：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.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Type of BCTs used by parent coded from the Hot Topics Task
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Parent measure.
|
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
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Parent measure.
|
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.
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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.
|
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
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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.
|
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
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
|
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
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
|
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
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
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.
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Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of BCTs used by parent coded from the End of Treatment Conversation
時間枠：Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Parent measure.
|
Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Type of BCTs used by parent coded from the End of Treatment Conversation
時間枠：Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Parent measure.
|
Change from session 1 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 End of Treatment Conversation
時間枠：Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Parent measure.
|
Change from session 1 to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Number of conflicts and the mean anger intensity for parent
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Measured via Issues Checklist.
Parent measure.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Number of conflicts and the mean anger intensity for youth
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Measured via Issues Checklist.
Youth measure.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's subjective Bedtime measured via Daily Sleep Diary
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Self-report of Bedtime in hour : minutes.
Bedtime discrepancy between weeknights and weekend nights is calculated.
Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's subjective Wakeup Time measured via Daily Sleep Diary
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Self-report of Wakeup Time in hour : minutes.
Wakeup Time discrepancy between weeknights and weekend nights is calculated.
Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's subjective Sleep Onset Latency (SOL) measured via Daily Sleep Diary
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Self-report of SOL in hour : minutes.
SOL discrepancy between weeknights and weekend nights is calculated.
Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's subjective Wake After Sleep Onset (WASO) measured via Daily Sleep Diary
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Self-report of WASO in hour : minutes.
WASO discrepancy between weeknights and weekend nights is calculated.
Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's subjective Number of Awakenings measured via Daily Sleep Diary
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Self-report of Number of Awakenings.
Number of Awakenings discrepancy between weeknights and weekend nights is calculated.
Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's subjective Time in Bed (TIB) measured via Daily Sleep Diary
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Self-report of TIB in hour : minutes.
TIB discrepancy between weeknights and weekend nights is calculated.
Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's subjective Naps measured via Daily Sleep Diary
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Self-report of Naps in hour : minutes.
Naps discrepancy between weeknights and weekend nights is calculated.
Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's subjective Total Sleep Time (TST) deviation score from developmental norms measured via Daily Sleep Diary
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
TST in minutes is computed for weeknights and weekend nights by using self-report of daily Bedtime, Wakeup Time, Sleep Onset Latency (SOL), Wake After Sleep Onset (WASO), Naps.
TST discrepancy between weeknights and weekend nights is calculated.
TST deviation score from developmental norms is calculated.
Daily Sleep Diary is obtained over a period of 7 days at pre and post-assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's subjective Sleep Midpoint measured via Daily Sleep Diary
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Sleep Midpoint in hour : minutes is computed for weeknights and weekend nights by subtracting Waketime from Bedtime and dividing the difference by TST [(bedtime-waketime)/TST].
Sleep Midpoint discrepancy between weeknights and weekend nights is calculated.
Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's subjective Total Wake Time measured via Daily Sleep Diary
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youths measure.
Total Wake Time in minutes is computed for weeknights and weekend nights by adding up Sleep Onset Latency and Wake After Sleep Onset (WASO).
Total Wake Time discrepancy between weeknights and weekend nights is calculated.
Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's subjective Sleep Efficacy measured via Daily Sleep Diary
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Sleep Efficacy in minutes is computed for weeknights and weekend nights by dividing Total Sleep Time (TST) by Time in Bed (TIB) times 100 (TST/TIB x 100).
Sleep Efficacy discrepancy between weeknights and weekend nights is calculated.
Daily Sleep Diary is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's objective Bedtime measured via Actigraphy
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Objective method of monitoring Bedtime in hour : minutes.
Bedtime discrepancy between weeknights and weekend nights is calculated.
Actigraphy is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's objective Wakeup Time measured via Actigraphy
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Objective method of monitoring Wakeup Time in hour : minutes.
Wakeup Time discrepancy between weeknights and weekend nights is calculated.
Actigraphy is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's objective Sleep Onset Latency (SOL) measured via Actigraphy
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Objective method of monitoring SOL in hour : minutes.
SOL discrepancy between weeknights and weekend nights is calculated.
Actigraphy is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's objective Wake After Sleep Onset (WASO) measured via Actigraphy
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Objective method of monitoring WASO in hour : minutes.
WASO discrepancy between weeknights and weekend nights is calculated.
Actigraphy is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's objective Number of Awakenings measured via Actigraphy
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Objective method of monitoring Number of Awakenings in hour : minutes.
Number of Awakenings discrepancy between weeknights and weekend nights is calculated.
Actigraphy is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's objective Time in Bed (TIB) measured via Actigraphy
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Objective method of monitoring TIB in hour : minutes.
TIB discrepancy between weeknights and weekend nights is calculated.
Actigraphy is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's objective Naps measured via Actigraphy
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Objective method of monitoring Naps in hour : minutes.
Naps discrepancy between weeknights and weekend nights is calculated.
Actigraphy is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's objective Total Sleep Time (TST) deviation score from developmental norms measured via Actigraphy
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
TST in minutes is computed for weeknights and weekend nights by using Bedtime, Wakeup Time, Sleep Onset Latency (SOL), Wake After Sleep Onset (WASO), Naps.
TST discrepancy between weeknights and weekend nights is calculated.
TST deviation score from developmental norms is calculated.
Actigraphy is obtained over a period of 7 days at pre and post-assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's objective Sleep Midpoint measured via Actigraphy
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Sleep Midpoint in hour : minutes is computed for weeknights and weekend nights by subtracting Waketime from Bedtime and dividing the difference by TST [(bedtime-waketime)/TST].
Sleep Midpoint discrepancy between weeknights and weekend nights is calculated.
Actigraphy is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's objective Total Wake Time measured via Actigraphy
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Total Wake Time in minutes is computed for weeknights and weekend nights by adding up Sleep Onset Latency and Wake After Sleep Onset (WASO).
Total Wake Time discrepancy between weeknights and weekend nights is calculated.
Actigraphy is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's objective Sleep Efficacy measured via Actigraphy
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Youth measure.
Sleep Efficacy in minutes is computed for weeknights and weekend nights by dividing Total Sleep Time (TST) by Time in Bed (TIB) times 100 (TST/TIB x 100).
Sleep Efficacy discrepancy between weeknights and weekend nights is calculated.
Actigraphy is obtained over a period of 7 days at pre and post assessment.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Parent's perception of coercion in parent-child relationship measured via Parent-Child Coercion Scale
時間枠：Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
Parent measure.
9 items each on a 5-point scale.
Total score is computed by adding up total points and dividing them by the number of items completed.
Total score ranges from 1 to 5. Higher scores indicate more coercion.
|
Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment
|
|
Youth's systolic blood pressure reactivity
時間枠：Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
|
Youth measure.
Blood pressure is measured using an ambulatory blood pressure monitor during the Hot Topic Task.
Readings will be averaged during the resting and task periods.
Reactivity will be calculated as the change score between the resting and task periods.
|
Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
|
|
Youth's diastolic blood pressure reactivity
時間枠：Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
|
Youth measure.
Blood pressure is measured using an ambulatory blood pressure monitor during the Hot Topic Task.
Readings will be averaged during the resting and task periods.
Reactivity will be calculated as the change score between the resting and task periods.
|
Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
|
|
Youth's heart rate variability
時間枠：Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
|
Youth measure.
Heart rate variability is measured using an ambulatory electrocardiogram during the Hot Topic Task.
HRV will be calculated as the root mean square of successive differences (RMSSD), which is the square root of the mean squared differences between successive beat-to-beat RR intervals.
|
Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
|
|
Parent's systolic blood pressure reactivity
時間枠：Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
|
Parent measure.
Blood pressure is measured using an ambulatory blood pressure monitor during the Hot Topic Task.
Readings will be averaged during the resting and task periods.
Reactivity will be calculated as the change score between the resting and task periods.
|
Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
|
|
Parent's diastolic blood pressure reactivity
時間枠：Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
|
Parent measure.
Blood pressure is measured using an ambulatory blood pressure monitor during the Hot Topic Task.
Readings will be averaged during the resting and task periods.
Reactivity will be calculated as the change score between the resting and task periods.
|
Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
|
|
Parent's heart rate variability
時間枠：Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
|
Parent measure.
Heart rate variability is measured using an ambulatory electrocardiogram during the Hot Topic Task.
HRV will be calculated as the root mean square of successive differences (RMSSD), which is the square root of the mean squared differences between successive beat-to-beat RR intervals.
|
Change from pre-treatment to post-treatment, which is an average of 9 weeks after the beginning of treatment. For control group: change from the first interview to the final interview, with 9 weeks spaced apart.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年12月1日
一次修了 (実際)
2020年8月11日
研究の完了 (実際)
2020年8月26日
試験登録日
最初に提出
2019年4月4日
QC基準を満たした最初の提出物
2019年4月22日
最初の投稿 (実際)
2019年4月24日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月5日
QC基準を満たした最後の更新が送信されました
2020年11月3日
最終確認日
2020年11月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。