An Emotion Regulation Intervention for Early Adolescent Risk Prevention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03430570|
Recruitment Status : Not yet recruiting
First Posted : February 13, 2018
Last Update Posted : February 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Risk Behavior Risk Reduction Emotion Regulation||Behavioral: Tablet TRAC Emotion Regulation Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized to complete a computerized intervention or a wait list control.|
|Masking:||None (Open Label)|
|Official Title:||An Emotion Regulation Intervention for Early Adolescent Risk Behavior Prevention|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||July 2019|
|Experimental: Tablet TRAC Emotion Regulation Intervention||
Behavioral: Tablet TRAC Emotion Regulation Intervention
The intervention focuses on developmentally appropriate strategies for emotion regulation during difficult situations, particularly those related to risk, using 3 primary groups of strategies identified during qualitative work in Project TRAC (R34 MH078750): 1) getting away (physically or cognitively) from triggers for strong emotions, 2) releasing emotional energy in healthy ways (physically or verbally) or 3) changing cognitions and appraisals about emotional triggers. Using strategies effective in TRAC, teens will engage in games to practice and apply strategies to risk scenarios, as well as personalize content learned.
No Intervention: Waitlist Control
Control participants are assessed on the same schedule as the treatment condition and offered the intervention after the 3-month follow-up
- Emotion Regulation/Difficulties in Emotion Regulation Scale [ Time Frame: baseline- 3 month follow up ]
Difficulties in Emotion Regulation Scale- The Difficulties in Emotion Regulation Scale (36 items) uses 6 subscales (all α > .80) to assess perceptions of skill in ER, awareness, and impulse control based on Linehan's theoretical work.
The six subscales are:
- Nonacceptance of emotional response (6 items)
- Difficulties engaging in goal directed behavior [goals] (5 items)
- Impulse control difficulties [impulse] (6 items)
- Lack of emotion awareness [awareness] (6 items)
- Limited access to emotion regulation strategies [strategies] (8 items)
- Lack of emotional clarity [clarity]. (5 items)
Participants rate their responses on a 5-point Likert scale ranging from 1 (almost never)- 5 (almost always). The total score is calculated from the sum of all the items, with higher scores indicating greater problems with emotion regulation. (Total possible range: 36-180)
- Emotion Recognition/DANVA [ Time Frame: Baseline-3 month follow up ]Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2) is a computer-based measure that asks participants to identify the emotion of facial expressions displayed in a series of 24 photographs and in 24 oral presentations of a neutral sentence, with higher scores indicating higher accuracy of emotion recognition. Total possible range = 0-48.
- Emotion Regulation/Emotion Regulation Checklist [ Time Frame: baseline-3 month follow up ]The Emotion Regulation Checklist contains 24 items on a 4-point Likert scale (1=never through 4= almost always; Total Range: 15-360). Parents rate 24 behavioral descriptions, yielding 2 subscales: 1) Lability/Negativity (α= .95), and 2) Emotion Regulation (α=.84). The Emotion Regulation subscale contains 8 items, while the Lability/Negativity scale contains 15 items. Higher scores on the Lability/Negativity scale indicate higher inflexibility, emotional reactivity, and dysregulated negative affect; higher scores on the emotion regulation subscale indicate greater situationally appropriate affective displays, empathy, and emotional self-awareness (Shields & Cicchetti, 1997). Alphas for the subscales are good (L/N α = .96; ER α = .83). One single measurement of emotion regulation is generated from the overall scores in both sub-scales (α = .89; Shields & Cicchetti, 1997).
- Emotion Regulation/ The Regulation of Emotions Questionnaire [ Time Frame: baseline-3 month follow up ]The Regulation of Emotions Questionnaire* (21 items) assesses frequency of use of both functional and dysfunctional emotion regulation strategies (α= >.66). Participants rate their responses on a 5-point Likert scale from 1- "never" through 5- "always". (Total Range: 21-110). Higher scores indicate higher frequency of use of emotion regulation strategies.
- Emotion Regulation/Self Efficacy Questionnaire for Children [ Time Frame: baseline-3 month follow-up ]The Emotional Self-efficacy subscale of the Self-Efficacy Questionnaire for Children (8 items) assesses perception of one's ability to cope with negative emotions (α= .83). It has been shown to be valid, reliable, and related to risk behaviors among US adolescents. Subjects rate their responses on a 5-point Likert scale from 1 "not at all" through 5 "very well". (Range: 8-40, with lower scores indicating low perception of ability to cope with negative emotions).
- Emotion Regulation/Emotion Regulation Behavior Scale [ Time Frame: baseline-3 month follow up ]The Emotion Regulation Behaviors Scale (8 items) measures use of the specific emotion regulation strategies taught in Project TRAC (α= .73). Participants respond on a scale of 1 (never) to 5 (all the time) across 8 items, with higher scores indicating more regulatory behaviors (range: 8-40).
- Emotion Regulation/Affect Dysregulation Scale [ Time Frame: baseline-3 month follow up ]The Affect Dysregulation Scale contains 6 items used to assess frequency of difficulty with affect regulation on 4-point Likert scale from 1=not at all to 4=often (α= .72), with higher scores indicating more difficulty managing feelings. affect (range: 6-36).
- Risk Behavior/Adolescent Risk Behavior [ Time Frame: baseline-3 month follow up ]The Adolescent Risk Behavior Assessment (ARBA) is a computer-assisted structured interview designed to assess adolescent self-reported sexual behaviors. Selected items will assess sexual behavior occurrence and frequency in the past 3 months at baseline and 3 months. A sample item from the Adolescent Risk Behavior Assessment is: "Has a boy EVER put his penis into your vagina (Have you ever put your penis into a girl's vagina)?"
- Assessment Risk Behavior/Youth Risk Behavior Surveillance System [ Time Frame: Baseline-3 month follow up ]7 items taken from the Center for Disease Control's Youth Risk Behavior Surveillance System will be used to assess adolescents' engagement in substance use, violence, and other risk behaviors. Participants will be asked risk behavior questions similar to the following item: "During the past 30 days, on how many days did you smoke cigarettes?" with answer choices ranging from 0, 1-2, 3-5, 6-9, 10-19, 20-29, 30.
- Distress Tolerance [ Time Frame: baseline-3 month follow up ]Behavioral Indicator of Resiliency to Distress (BIRD) and Mirror Tracing Persistence Task (MTPT) are 5-minute computerized distress tolerance tasks that generate a score of time spent persisting on a dysregulating task that provides negative feedback (aversive noise) when users do not succeed at very challenging tasks, with more time spent on the tasks indicating greater distress tolerance. Possible range = 0-300 seconds.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430570
|Contact: Brittany M Wickham, BAfirstname.lastname@example.org|
|Contact: Wendy Hadley, PhDemail@example.com|
|United States, Rhode Island|
|Rhode Island Hospital- Bradley Hasbro Children's Research Center||Active, not recruiting|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Christopher Houck, PhD||Rhode Island Hospital|