Emotional Regulation Intervention for Adolescents

(RELAX Trial)

Overseen By Rosanna Breaux, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Disqualifiers: No ADHD, Age outside 11-16, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the RELAX program, a group-based telehealth intervention, to evaluate its effectiveness in helping teens manage their emotions. The program is compared to a control group receiving educational materials on handling emotions and conflicts. Additionally, a pilot study involves some families testing smartphone apps designed to support the skills learned. Families with children in middle or high school who have ADHD and no severe developmental delays may be suitable for this study. As an unphased trial, this study provides families with a unique opportunity to contribute to innovative research and potentially benefit from new emotional management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the RELAX intervention is safe for adolescents?

Research shows that the RELAX program helps teenagers manage their emotions more effectively. It supports teens with ADHD and their families by teaching coping and communication skills. Although specific information on side effects or safety is not available, previous studies have examined this program.

Since this study involves a program rather than medication, safety concerns differ from those in drug trials. Generally, programs like RELAX are considered low-risk because they focus on skill development rather than drug use. As part of a broader effort to aid emotional control, participants are likely to receive it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The RELAX intervention is unique because it offers a group-based telehealth approach specifically targeting emotional regulation for adolescents. Unlike traditional therapies that might involve in-person sessions or medication, RELAX provides remote access, making it more accessible and convenient for teens. Researchers are excited about this treatment because it integrates interactive and engaging methods for teaching emotion regulation, potentially leading to improved mental health outcomes for adolescents struggling with emotional challenges.

What evidence suggests that the RELAX intervention is effective for emotional regulation in adolescents?

Research has shown that the RELAX program, which participants in this trial may receive, can greatly help teenagers manage their emotions. Earlier studies found significant improvements in how both parents and teenagers rated the teens' ability to handle emotions. In one small study, families noticed that teenagers were better at dealing with negative feelings after completing the RELAX program. This program teaches skills for managing emotions and resolving conflicts, with support from parents. Overall, the RELAX program appears promising in helping teenagers control their emotions more effectively. ^{1 2 5 6 7}

Who Is on the Research Team?

Rosanna Breaux, PhD

Principal Investigator

Virginia Polytechnic Institute and State University

Are You a Good Fit for This Trial?

This trial is for adolescents with ADHD who might also be struggling with mobile phone addiction. It's open to families willing to try a new intervention called RELAX or receive psychoeducational materials. The study will exclude certain individuals based on criteria not specified here.

Inclusion Criteria

My child does not have severe developmental delays from genetic conditions or birth complications.

Participating parent/legal guardian has custody/medical decision making of the child

Child has an estimated verbal IQ >= 80 based on the Wechsler Intelligence Scale for Children, Fifth Edition Verbal Comprehension Index

Exclusion Criteria

Child not diagnosed with ADHD as confirmed by prior documented diagnosis and/or current comprehensive ADHD assessment as part of intake visit

Participating parent not having legal custody of the child

Having parents or children who are not fluent in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RELAX intervention or psychoeducational materials over 8 weekly sessions

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 6-month follow-up period

6 months

Ecological Momentary Intervention (EMI) Pilot Study

Ten families participate in a pilot study using smartphone apps to practice skills learned during RELAX

4 weeks

1 focus group session

What Are the Treatments Tested in This Trial?

Interventions

• RELAX

Trial Overview The trial is testing the RELAX intervention against standard psychoeducational materials to see which helps more with emotion regulation in teens with ADHD. Half of the participants will get RELAX, and half will get educational materials, decided randomly.

How Is the Trial Designed?

Group I: RELAX Intervention Experimental Treatment 1 Intervention

group-based RELAX telehealth intervention

Group II: Psychoeducational Waitlist Control Active Control 1 Intervention

The psychoeducational component will consist of infographics regarding emotion regulation strategies and managing interpersonal conflict.

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Published Research Related to This Trial

The abbreviated progressive muscle relaxation (APMR) program showed a high adherence rate of 99.1% among female adolescents, indicating it is a feasible method for stress management in schools.

While APMR helped maintain physiological stability in hair cortisol concentration (HCC), it did not significantly reduce perceived stress levels as measured by the Perceived Stress Scale (PSS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A School-Based Progressive Muscle Relaxation Program for Female Adolescents: Development and the Effectiveness on Physiological and Psychological Evidence. Tsai, ML., Cheng, TH., Yang, YK., et al.[2021]

Imagery-based relaxation training was more effective in inducing physiological relaxation in children, as evidenced by significant decreases in heart rate and skin conductance, while progressive muscle relaxation actually increased heart rate during the training.

All relaxation methods, including a neutral story, improved children's mood and physical well-being, but there were no significant differences in outcomes between the different relaxation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychophysiological effects of relaxation training in children. Lohaus, A., Klein-Hessling, J., Vögele, C., et al.[2006]

Autogenic relaxation training significantly reduced behavioral symptoms in children and adolescents with internalizing and some externalizing symptoms, as reported by parents, with a clinically relevant effect size of 0.49.

The intervention showed promising results in goal attainment, with 56% of children and 55% of parents reporting partial success by the end of the program, and 71% of parents confirming partial goal attainment three months later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of autogenic relaxation training on children and adolescents with behavioral and emotional problems. Goldbeck, L., Schmid, K.[2016]

A comprehensive review of 41 studies on emotion regulation (ER) interventions in adolescents showed a significant overall effect, indicating that these interventions can improve ER skills, with a pooled effect size of Hedge's g = 0.29.

Community-based interventions had lower effect sizes compared to clinical populations, suggesting that the type of population may influence the efficacy of ER interventions, highlighting the need for tailored approaches in different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Meta-Analytic Review of Emotion Regulation Focused Psychosocial Interventions for Adolescents. Eadeh, HM., Breaux, R., Nikolas, MA.[2022]

The pilot study involving 39 adolescents (ages 13-18) found that adding guided internet-based emotion regulation training (ERT) to cognitive behavioral therapy (CBT) was feasible and acceptable, with a treatment adherence rate of 66.5%.

Preliminary results indicated that the CBT + ERT group experienced significantly reduced anxiety and depressive symptoms, as well as improved emotion regulation strategies, compared to the CBT-only group at the six-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based emotion-regulation training added to CBT in adolescents with depressive and anxiety disorders: A pilot randomized controlled trial to examine feasibility, acceptability, and preliminary effectiveness. Wisman, MA., Emmelkamp, J., Dekker, JJM., et al.[2022]

In a study of 152 adolescents, those who experienced more intense and unstable emotions, along with less effective emotion regulation strategies, reported higher levels of depressive symptoms and problem behaviors.

Ineffective strategies like disengagement (denial) and involuntary engagement (rumination) were linked to increased negative emotions and were associated with greater depressive symptoms, highlighting the importance of effective emotion regulation in mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescents' emotion regulation in daily life: links to depressive symptoms and problem behavior. Silk, JS., Steinberg, L., Morris, AS.[2022]

The Mindfulness and Awareness Program (MAP), which included eight 20-minute sessions focused on mindfulness meditation, significantly improved emotional regulation and reduced depression and anxiety among 349 junior high school students in Japan.

The program's effects were more pronounced at follow-up assessments and were particularly beneficial for female students, highlighting its potential as an effective preventive intervention for mental health in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of school-based brief cognitive behavioral therapy with mindfulness in improving the mental health of adolescents in a Japanese school setting: A preliminary study. Kato, K., Matsumoto, Y., Hirano, Y.[2022]

A relaxation response-based curriculum integrated into the school day significantly reduced perceived stress and state anxiety among high school students, particularly benefiting girls in the intervention group.

The study highlights the feasibility and acceptability of this intervention, suggesting it could be a valuable tool for improving students' overall well-being and health-promoting behaviors in a school setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating a relaxation response-based curriculum into a public high school in Massachusetts. Foret, MM., Scult, M., Wilcher, M., et al.[2012]

A pilot study in a Boston charter school demonstrated that a relaxation response (RR) curriculum taught by teachers significantly reduced students' anxiety and perceived stress, with improvements measured using various psychological scales.

The implementation of the RR curriculum not only enhanced students' stress management behaviors but also increased overall classroom productivity, indicating that such programs can positively impact both emotional health and learning environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teacher-led relaxation response curriculum in an urban high school: impact on student behavioral health and classroom environment. Wilson, HK., Scult, M., Wilcher, M., et al.[2015]

A systematic review identified 87 self- and informant-report measures of emotion regulation (ER) for children and adolescents, with only 8% classified as Excellent, indicating a need for improved assessment tools in this area.

The review highlights the strengths and weaknesses of existing ER measures, providing guidance for researchers and clinicians in selecting appropriate tools while also identifying gaps in the literature that could inform future research and measure development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence Base Update for Questionnaires of Emotion Regulation and Reactivity for Children and Adolescents. Mazefsky, CA., Conner, CM., Breitenfeldt, K., et al.[2023]

Three boys with hyperactivity successfully learned Behavioral Relaxation Training (BRT) at home, achieving at least 80% proficiency in relaxation skills, which were maintained at follow-ups one and three months later.

Parent ratings indicated significant improvements in hyperactive behavior after BRT, suggesting that relaxation training can be an effective alternative to medication for managing hyperactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching parents to conduct behavioral relaxation training with their hyperactive children. Donney, VK., Poppen, R.[2019]

A systematic review of 36 studies on school-based interventions for emotional regulation in adolescents found small to moderate effect sizes for improving mental health and emotional regulation skills, indicating these programs can be beneficial.

Interventions targeting high-risk populations showed medium to high effect sizes, while universal programs for all students had more variable outcomes, suggesting tailored approaches may be more effective for at-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based interventions to improve emotional regulation skills in adolescent students: A systematic review. Pedrini, L., Meloni, S., Lanfredi, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03733548

Improving Emotion Regulation in Adolescents With ADHD RELAX is an experimental intervention that may equip adolescents with emotion regulation and conflict management skills and includes parent involvement to ...

2. tandfonline.com tandfonline.com/doi/abs/10.1080/23794925.2020.1759468

Development and Refinement of the RELAX Intervention ... All outcomes were collected pre- and post-RELAX. Adolescents made large improvements on parent and adolescent ratings of emotion dysregulation ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8573252/

Emotional Dysregulation in Children and Adolescents With ... Emotional dysregulation (ED) is a transdiagnostic construct defined as the inability to regulate the intensity and quality of emotions.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589979124000234

A systematic review of interventions aimed at improving ... The aim of this review was to map the landscape of interventions targeting emotional regulation difficulties and identify their effectiveness and the ...

5. calmerlab.com calmerlab.com/the-relax-intervention

The RELAX Intervention RELAX was piloted with 18 families in Spring 2019 and was found to result in large improvements in adolescent emotion regulation (i.e., managing negative ...

6. mental.jmir.org mental.jmir.org/2025/1/e56066

A Narrative Review to Identify Promising Approaches for ... This review identifies promising therapeutic approaches for digital health interventions to support emotion regulation in adolescents with ADHD ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0022395624002310

Interventions targeting emotion regulation: A systematic ... Our goal was to investigate the psychotherapeutic interventions used to address ED and gauge their effectiveness, safety, and potential mechanisms across ...