About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
RELAX
BehavioralThe RELAX intervention is a social-emotional intervention consisting of 8 weekly, 1.5 hr sessions and a booster session 1 month and 6 months after the completion of RELAX. During the first 60 minutes of RELAX sessions, parents and adolescents meet separately; during the last 30 minutes combined parent-adolescent discussion and problem-solving activities take place. RELAX is structured such that parents learn emotion regulation/coping skills the week prior to them being taught to the adolescents. Group sessions will involve both didactics and discussion of topics including psychoeducation, basic cognitive/behavioral principles, emotional awareness, emotion regulation strategies, parent emotion socialization practices, coping skills, conflict management strategies, and communication skills.
Psychoeducational Materials
BehavioralInfographics with information on emotion regulation development, emotion regulation strategies, and strategies for managing interpersonal conflict, including when different strategies are more or less effective will be provided to participants via email.
Treatment groups
Trial outcomes
Primary outcomes
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
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)
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
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)
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.
Secondary outcomes
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Adolescent self-report of their depression symptoms will be collected using the CES-DC. The CES-DC consists of 20 items assessing depression symptoms rated on a 4-point scale (0 = Not At All, 4 = A Lot). The CES-DC total score represents the sum across the 20 items, with possible scores ranging from 0 to 60. Higher CES-DC scores indicate increasing levels of depression.
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Adolescent self-report on the SCARED will be used to measure adolescent anxiety symptoms. The SCARED consists of 41 items rated on a 3-point scale (0 = Not True or Hardly Ever True, 2 = Very True or Often True). The SCARED measures overall anxiety symptoms, Panic Disorder, Generalized Anxiety Disorder, Separation Anxiety, Social Anxiety, and School Avoidance. Higher scores on each subscale represent more anxiety symptoms. The overall anxiety total score will be used in the current study; scores can range from 0-82, with higher scores indicating more anxiety symptoms and a total score of ≥ 25 indicating the possible presence of an Anxiety Disorder.
Proactive and Reactive Aggression Measure (PRAM)
The PRAM will be used to measure adolescent self-reported proactive and reactive aggression. The PRAM consists of 6 items that differentiate between reactive aggression (3 items; e.g., "When I have been teased or threatened I get angry easily and strike back") and proactive aggression (3 items; e.g., "I threaten or bully others in order to get my way."). Items are anchored on a 5-point scale (1 = never, 5 = almost always). The two subscales range from 3 - 15 points; the total aggression score ranges from 6 - 30 points, with higher scores indicating the presence of more aggression in the adolescent.
Self-Injurious Thoughts and Behaviors
Adolescent report on a questionnaire developed from the Self-Injurious Thoughts and Behaviors Interview will be used to assess suicide ideation, plans, gestures, and attempts, and non-suicidal self-injury. First, adolescents are asked if they have ever had thoughts of killing themselves. If they answer yes, they are asked how old they were the first time they had thoughts of killing themself, how often (# of weeks in last year) they have had such thoughts, and the last time they had thoughts of killing themself. Next, they are asked if they ever wish they were dead followed by if they ever made a plan to kill themself; if they respond yes to either or both, the same 3 follow-up questions are asked for each. Then they are asked if they have ever attempted suicide. If they answer yes, they are asked how old they were at the first attempt, how many attempts they have had, the last attempt, and the method used for the attempts. Finally, injury resulting from attempts or NSSI is assessed.
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