RELAX Telehealth InterventionRELAXNCT06725186
Regulating Emotions Like An eXpert Among Adolescents With ADHD
A study testing RELAX and Psychoeducational Materials in people with RELAX Telehealth Intervention and Psychoeducational Waitlist Control, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- RELAX Telehealth Intervention, Psychoeducational Waitlist Control, EMI Smartphone App Pilot
- What is being tested?
- RELAX and Psychoeducational Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Child Study Center
Blacksburg, Virginia, 24060
Rosanna Breaux, PhD, 540-231-8276, calmerlab@gmail.com
About this study
Official title: Improving Emotion Dysregulation and Interpersonal Conflict Among Families of Adolescents With ADHD
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.
Read the detailed description
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.
- Conditions
- RELAX Telehealth Intervention, Psychoeducational Waitlist Control, EMI Smartphone App Pilot
- Being tested
- RELAX, Psychoeducational Materials
- Keywords
- ADHD, telehealth, emotion regulation, family conflict, parenting
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELAXBehavioural
The 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 MaterialsBehavioural
Infographics 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.
| Study group | Role | What they receive |
|---|---|---|
| RELAX Intervention | Experimental | group-based RELAX telehealth intervention Receives: Behavioral: RELAX |
| Psychoeducational Waitlist Control | Active comparator | The psychoeducational component will consist of infographics regarding emotion regulation strategies and managing interpersonal conflict. Receives: Behavioral: Psychoeducational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the 6-month follow-up period.
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.
Measured: From enrollment to the 6-month follow-up period.
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.
Measured: From enrollment to the 6-month follow-up period.
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.
Measured: From enrollment to the 6-month follow-up period.
Coping with Children's Negative Emotions Scale (CCNES) - Adolescent Version -
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.
Measured: From enrollment to the 6-month follow-up period.
Secondary outcomes (8)
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.
Measured: From enrollment to the 6-month follow-up period.
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.
Measured: From enrollment to the 6-month follow-up period.
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.
Measured: From enrollment to the 6-month follow-up period.
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.
Measured: From enrollment to the 6-month follow-up period.
Vanderbilt ADHD Rating Scale (VARS)
The VARS will be used to assess parent report of ADHD, ODD, and CD symptoms, and social and academic impairment. The VARS consists of 40 symptom items (18 ADHD, 8 ODD, 14 CD) rated on a 4-point scale ranging from 0 - Never to 3 - Very Often. Any item endorsed as happening Often or Very Often is counted as a clinical symptom for that disorder, with the symptom count for each disorder being used and higher values indicating more symptom severity. Finally, 8 impairment items are asked on which the parents rate how much various areas (School Performance; Relationships with Parents, Siblings, Peers; Participation in Organized Activities) problems for the child on a 5-point scale ranging from 1 - Excellent Performance to 5 - Problematic. A total impairment score can be calculated by summing the 8 items (range = 8 - 40), with higher scores indicating more impairment in each domain.
Measured: From enrollment to the 6-month follow-up period.
Homework Performance Questionnaire (HPQ)
Academic performance will be measured using parent report on the HPQ. The HPQ items are on a 7-point Likert scale ranging from 0 (Never/Rarely, 0-10% of the time) to 6 (Almost Always/Always, 91% to 100% of the time). Percentages indicate how often a behavior occurs, with items worded in the positive such that 91-100% means the adolescent does that behavior consistently well. Thus, higher scores indicate less impairment.
Measured: From enrollment to the 6-month follow-up period.
Depression Anxiety Stress Scales - 21 item (DASS-21)
The DASS-21 will be used to assess parents' report of their own depression, anxiety, and stress symptoms, given evidence that parent depression and stress is related to child emotional and behavioral outcomes and ratings of child behavior. The 21 items are rated on a 4-point scale ranging from 0 - Did not apply to me at all to 3 - Applied to me very much, or most of the time, indicating how often over the past week they have experienced the various symptoms. Each subscale (depression, anxiety, stress) consists of 7 items (range = 0 - 21), with the DASS-21 total score ranging from 0 - 63, with higher scores indicating more severe internalizing symptoms (scores of 28+ are considered extremely severe on this measure).
Measured: From enrollment to the 6-month follow-up period.
Alabama Parenting Questionnaire - Short Form (APQ-9)
The APQ-9 will be used to assess changes in parent and adolescent report on global parenting behaviors. Each of the 9 items are rated on a 5-point scale ranging from Never (1) to Always (5). The scores for each of the three subscales are added together to create three subscale scores: Positive parenting (Items 1, 6 and 7), Inconsistent discipline (Items 2, 4, and 9), and Poor supervision (items 3, 5, 8), which values ranging from 3 - 15 for each subscale and higher values indicating a greater likelihood that these parenting behaviors typically occur in their home.
Measured: From enrollment to the 6-month follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start15 Jan 2025
- Primary completionMay 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RELAX Telehealth InterventionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosanna Breaux, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725186
- Sponsor's protocol ID
- 24-1281
- Acronym
- RELAX
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Breaux, R., Shroff, D. M., Cash, A. R., Swanson, C. S., Carlton, C., Bertollo, J. R., & Dahiya, A. V. (2023). Telehealth delivery of the RELAX intervention for families of adolescents diagnosed with ADHD: Preliminary treatment outcomes and evidence of acceptability and feasibility. Evidence-Based Practice in Child & Adolescent Mental Health, 8, 24-38. doi: 10.1080/23794925.2021.1970053
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Emotion Dysregulation and Interpersonal Conflict Among Families of Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT06725186
- Acronym / sponsor ID
- RELAX / 24-1281
- Conditions
- RELAX Telehealth Intervention, Psychoeducational Waitlist Control, EMI Smartphone App Pilot
- Keywords
- ADHD, telehealth, emotion regulation, family conflict, parenting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Dec 2024 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RELAX Intervention | Experimental | Behavioral: RELAXgroup-based RELAX telehealth intervention |
| Psychoeducational Waitlist Control | Active comparator | Behavioral: Psychoeducational MaterialsThe psychoeducational component will consist of infographics regarding emotion regulation strategies and managing interpersonal conflict. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| RELAXThe 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. | Behavioural | RELAX Intervention |
| Psychoeducational MaterialsInfographics 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. | Behavioural | Psychoeducational Waitlist Control |
Primary outcome
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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 -
Time frame: 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.
8 secondary outcomes
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Time frame: From enrollment to the 6-month follow-up period.
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time frame: From enrollment to the 6-month follow-up period.
Proactive and Reactive Aggression Measure (PRAM)
Time frame: From enrollment to the 6-month follow-up period.
Self-Injurious Thoughts and Behaviors
Time frame: From enrollment to the 6-month follow-up period.
Vanderbilt ADHD Rating Scale (VARS)
Time frame: From enrollment to the 6-month follow-up period.
Homework Performance Questionnaire (HPQ)
Time frame: From enrollment to the 6-month follow-up period.
Depression Anxiety Stress Scales - 21 item (DASS-21)
Time frame: From enrollment to the 6-month follow-up period.
Alabama Parenting Questionnaire - Short Form (APQ-9)
Time frame: From enrollment to the 6-month follow-up period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- BackgroundBreaux, R., Shroff, D. M., Cash, A. R., Swanson, C. S., Carlton, C., Bertollo, J. R., & Dahiya, A. V. (2023). Telehealth delivery of the RELAX intervention for families of adolescents diagnosed with ADHD: Preliminary treatment outcomes and evidence of acceptability and feasibility. Evidence-Based Practice in Child & Adolescent Mental Health, 8, 24-38. doi: 10.1080/23794925.2021.1970053
- CALMER Lab Website Description of the RELAX InterventionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Rosanna Breaux, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RELAX and Psychoeducational Materials in people with RELAX Telehealth Intervention and Psychoeducational Waitlist Control, run by Virginia Polytechnic Institute and State University 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosanna Breaux, PhD (5402318276, calmerlab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF) (time frame: From enrollment to the 6-month follow-up period.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06725186, which also lists 1 linked publication.
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 30 Mar 2026.