Improving Emotion Dysregulation and Interpersonal Conflict Among Families of Adolescents With ADHD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
研究概览
简要总结
This study consists of a randomized controlled trial assessing the acceptability, feasibility, and efficacy of the RELAX (Regulating Emotions Like An eXpert) Intervention. Following randomization, 30 families will receive the RELAX intervention and 30 families will receive psychoeducational materials as part of a control condition. Additionally, 10 families from the RELAX condition will participate in a pilot study and focus groups to give feedback on developed smartphone apps to support skill use during and following completion of RELAX.
详细描述
This study seeks to quantify the efficacy of the telehealth RELAX intervention (n = 30) relative to a psychoeducational waitlist control (PWL; n = 30) through a RCT. The psychoeducational component will consist of infographics for parents and adolescents regarding ER strategies, parent emotion socialization, and managing interpersonal conflict. Participants will be 60 adolescents with ADHD in middle or high school (ages 11-16) who display moderate to severe emotion dysregulation as measured by the Difficulties in Emotion Regulation Scale, and a primary caregiver. Adolescents will have an estimated verbal IQ ≥ 80, as indicated by the Wechsler Intelligence Scale for Children, Fifth Edition Verbal Comprehension Index, with no evidence of severe developmental delay. All participants must be proficient in English. Adolescents may have comorbid conditions, so the sample will represent real-world adolescents with ADHD.
Ten families who complete the RELAX intervention will be asked to participate in the ecological momentary intervention (EMI) pilot study which will assess the developed EMI procedure's acceptability, appropriateness, and feasibility of using smartphone apps to practice the skills learned during RELAX both during the original 8 weekly sessions and throughout the 6 month follow-up period using Likert-ratings. Additionally, they will be asked if they are interested in accessing the mobile apps for a 4-week period to continue practicing the skills learned in RELAX and to provide more in-depth feedback on the app to the research team via a 1-hour focus group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child with ADHD in middle or high school at time of study entry
- •child has an estimated verbal IQ >=80 based on the Wechsler Intelligence Scale for Children, Fifth Edition Verbal Comprehension Index
- •child has no evidence of severe developmental delay either from genetic origins (e.g., Down Syndrome) or complications during pregnancy/birth (e.g., infection, micropremature)
- •participating parent/legal guardian has custody/medical decision making of the child
- •family uses English as one of their primary languages (i.e., able to participate in study visits and intervention conducted in English)
排除标准
- •child not diagnosed with ADHD as confirmed by prior documented diagnosis and/or current comprehensive ADHD assessment as part of intake visit
- •having a child outside of the eligible age range of 11-16 at time of study enrollment
- •participating parent not having legal custody of the child
- •having parents or children who are not fluent in English
- •having a child with a severe developmental delay either from genetic origins (e.g., Down Syndrome) or complications from pregnancy/birth (e.g., infection, micro-premature)
- •child has an IQ < 70.
研究组 & 干预措施
RELAX Intervention
group-based RELAX telehealth intervention
干预措施: RELAX (Behavioral)
Psychoeducational Waitlist Control
The psychoeducational component will consist of infographics regarding emotion regulation strategies and managing interpersonal conflict.
干预措施: Psychoeducational Materials (Behavioral)
结局指标
主要结局
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
时间窗: From enrollment to the 6-month follow-up period.
The DERS-SF will be used to assess emotion regulation problems (e.g., poor emotion awareness, poor emotion clarity, non-acceptance of emotions, poor access to emotion regulation strategies). The DERS will be completed at all timepoints by both parents and adolescents, with parents completing ratings for themselves and for their adolescents. The 18 DERS items are rated on a 5-point scale ranging from 1 - Almost Never (0-10%) to 5 - Almost Always (91-100%) and the total score represents a sum across items (with 3 items reversed score; range = 18-90) such that higher scores indicate greater dysregulation.
Cognitive Emotion Regulation Questionnaire (CERQ)
时间窗: From enrollment to the 6-month follow-up period.
The CERQ is a 36-item scale designed to evaluate cognitive aspects of emotion regulation or cognitive coping strategies (e.g., self-blame, rumination, putting into perspective, positive reappraisal, acceptance). Parents and adolescents are asked to rate what they generally think when they experience negative or unpleasant events on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). Each subscale consists of 4 items. Of the 4 items included in a scale a sum score is made (simple straight count), which can range from 4 (never used) to 20 (often used cognitive coping strategy). Not more than 1 of the 4 items included in a scale may be 'missing'. In that case, the 'missing' score is replaced by the average of the three remaining scores. In this manner, even in the case of a missing value, a scale score ranging from 4 to 20 is obtained, with higher scores indicating more often using that particular cognitive coping strategy.
Observed Parent Emotion Socialization Strategies
时间窗: From enrollment to the 6-month follow-up period.
The Conflict Discussion Task will be coded for parent emotion socialization in response to adolescents' distress through seven possible reactions: emotion-focused (i.e., empathy and validation), problem-focused (i.e., targeting the stressor itself with questions and advice), minimizing (i.e., dismissing the affect as unimportant), punitive (i.e., blaming the adolescent for the affect); magnifying (i.e., intensifying adolescents' affect), autonomy-inhibiting (i.e., interfering with adolescents' independence in dealing with their affect), and facilitative engagement (i.e., general sensitivity and responsiveness to adolescents' attempts to discuss affect). Responses are coded on a scale representing an (1) absence, (2) minimal, (3) moderate, or (4) strong presence of the behavior reflected. These codes will be collapsed into supportive (emotion-focused, problem-focused, facilitative engagement) and non-supportive (minimizing, punitive, magnifying, autonomy-inhibiting) responses.
Conflict Behavior Questionnaire (CBQ)
时间窗: From enrollment to the 6-month follow-up period.
The CBQ consists of 20 true-false questions regarding how well parent and adolescents get along, get angry at each other, and behaviors that occur during arguments. The CBQ total score ranges from 0-20 with higher scores indicating more parent-adolescent conflict.
Coping with Children's Negative Emotions Scale (CCNES) - Adolescent Version -
时间窗: From enrollment to the 6-month follow-up period.
Parent and adolescent report on the CCNES Adolescent Version will be collected to assess changes in parent emotion socialization. The CCNES-Adolescent consists of 9 hypothetical situations, each with 6 possible responses for how parents would react rated on a 7-point Likert scale ranging from 1 - Very Unlikely to 7 - Very Likely. These 6 response types each become a subscale (distress, punitive, expressive encouragement, emotion-focused, problem-focused, and minimization), with each subscale score representing the mean rating across the 9 items. These 6 subscales can be further collapsed into supportive (expressive encouragement, emotion-focused, problem-focused) and non-supportive (distress, punitive, minimization) responses, with higher scores indicating a greater likelihood a parent will use that particular response type.
次要结局
- Center for Epidemiological Studies Depression Scale for Children (CES-DC)(From enrollment to the 6-month follow-up period.)
- Screen for Child Anxiety Related Emotional Disorders (SCARED)(From enrollment to the 6-month follow-up period.)
- Proactive and Reactive Aggression Measure (PRAM)(From enrollment to the 6-month follow-up period.)
- Self-Injurious Thoughts and Behaviors(From enrollment to the 6-month follow-up period.)
- Vanderbilt ADHD Rating Scale (VARS)(From enrollment to the 6-month follow-up period.)
- Homework Performance Questionnaire (HPQ)(From enrollment to the 6-month follow-up period.)
- Depression Anxiety Stress Scales - 21 item (DASS-21)(From enrollment to the 6-month follow-up period.)
- Alabama Parenting Questionnaire - Short Form (APQ-9)(From enrollment to the 6-month follow-up period.)