Virtual ACT for Adolescent Stress

NCT04978610 | Terminated

• 1 other identifier: CHLA-20-00665
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to test the effectiveness of a 6-week long virtual Acceptance Commitment group therapy as a non-pharmaceutical intervention to improving other functional outcomes for adolescents with a chronic medical condition in comparison to no treatment.

Conditions

Chronic Illness

Keywords

Virtual Therapy; Group Therapy; Chronic Medical Condition; Adolescent

Outcome Measures

Primary Outcomes (1)

• Assess Change via the Perceived Stress Scale (PSS)

  The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. SS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items and then summing across all scale items with higher scores correlating to more stress. There are ten items total with the minimum value set at 0 and maximum 40 with higher scores correlating to more perceived stress.

  baseline at the start of study, through study competition (up to 6 weeks), change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks

Secondary Outcomes (8)

• Assess Change via the Faces Pain Scale-Revised (FPS-R)

  baseline at the start of study, through study competition (up to 6 weeks), change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks

• Assess Change via the Behavior Assessment System for Children, Third Edition (BASC-3)

  baseline at the start of study and change from baseline at 6 weeks

• Assess Change via the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 v2.0 (PROMIS-25)

  baseline at the start of study, change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks

• Assess Change via the Comprehensive Adolescent Severity Inventory (CASI)

  baseline at the start of study, change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks

• Assess Change via the Acceptance and Action Questionnaire (AAQ-II)

  baseline at the start of study and change from baseline at 6 weeks

Study Arms (2)

Intervention (Immediate)

EXPERIMENTAL

Participants in the intervention group will begin their 6-week vACT sessions first and complete baseline, the weekly surveys during intervention, post, one month follow-up, and three month follow-up.

Behavioral: Virtual Acceptance Commitment Therapy

Control (Waitlist)

OTHER

Upon the intervention group's completion of the 6-week long vACT, the control group will then enroll into their own 6-week long ACT intervention. The research protocol for the second 6-week long ACT intervention will mirror the protocol with the original 6-week long ACT intervention, except for one change: participants will NOT complete an additional baseline questionnaire prior to starting the 6-week ACT therapy group. The rest of the protocol remains the same. Namely, before each session, each participant will be required to fill out a short survey on their stress and pain throughout previous week. At the conclusion of the final session, participants will follow the complete post-intervention battery of surveys, which mirrors the baseline measures plus the inclusion of satisfaction surveys assessing the effectiveness of the virtual therapy intervention. Participants will complete the post-intervention follow up battery of questionnaires at 1 and 3 months post-intervention.

Behavioral: Virtual Acceptance Commitment Therapy

Interventions

Virtual Acceptance Commitment Therapy BEHAVIORAL

For a period of 6 continuous weeks, participants will meet weekly in a virtual group ACT session with a licensed psychologist hosted on a secure, HIPAA compliant, Zoom account. Each session is 1.5 hours will focus on one ACT concept including Acceptance, Values, Mindfulness, Cognitive Defusion, Experiential Avoidance, and Willingness and Committed Action. Subjects will be given the opportunity to share their thoughts as well as their responses to the exercises at various points throughout the sessions. At the beginning of each session, each participant will be required to fill out a short survey on their stress and pain the preceding week. Participants in the control group will not complete weekly measures. All measures will be completed online via a REDCap survey web link. Follow up measures will mirror initial baseline measures in order to measure the within group and between group changes in study outcomes.

Control (Waitlist); Intervention (Immediate)

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children who are English speaking
• Children who are diagnosed with a chronic illness: Defined as a condition that lasts 1 year or more and requires ongoing medical attention or limits activities of daily living or both (excluding obesity).
• Children with access to a device with internet and webcam capabilities
• Children with access to a private setting to participate in the intervention
• Must be 18 years or older and legal guardian of enrolled child
• English or Spanish speaking, with an ability to read in their language

You may not qualify if:

• \. Known developmental delay that precludes the ability to complete questionnaires or participate in group therapy

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey I Gold, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

• Nicole Mahrer, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: After informed consent and assent have been obtained and the patient has successfully met the screening criteria, the patient will be enrolled. The study will commence upon the enrollment of approximately 20 participants, at which point participants will be randomized into the Virtual ACT or waitlist (control) group. The intervention group will begin vACT immediately, while the waitlist receive no intervention during the same 6-week time frame. Both groups will take the same baseline questionnaires and post-questionnaires (post, 1 month, and 3 month). After the vACT intervention group finishes, another 6-week vACT session will be offered to the waitlist. The waitlist group will fill out a post-therapy questionnaire again after their 6-weeks. The parents of both groups will fill out a baseline questionnaire and post questionnaires. The investigators will repeat this protocol until 144 participants or 72 caregiver-child dyads.

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 27, 2021
• Study Start: March 3, 2021
• Primary Completion: March 4, 2026
• Study Completion: March 4, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)