Virtual ACT for Adolescent Stress

Study Overview
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Brief Summary
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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.

Detailed Description
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Upwards of 40% of children and adolescents/young adults (AYAs) in the United States suffer from at least one chronic medical condition, excluding obesity. The emotional and psychological burden of having a chronic condition in youth can lead this population to experience higher rates of stress, depression, and anxiety in addition to reduced health-related quality of life compared to their healthy peers. Acceptance and Commitment Therapy (ACT) is an intervention that teaches skills such as psychological flexibility, mindfulness, and cognitive defusion that has been shown to significantly improve psychological outcomes and quality of life among children and AYAs with chronic conditions. Few studies, however, have examined the efficacy of this intervention in reducing stress among children and AYAs with chronic conditions delivered in a group, web-based format. The need for virtually administered psychological interventions is especially salient amidst the Covid-19 pandemic as CDC guidelines discourage in-person gatherings and close contact with others. The current study aims to: 1) Determine if a web-based group ACT intervention of 6 sessions is more effective than no intervention (waitlist control) in reducing stress among children and AYAs with chronic conditions, 2) Determine if a web-based group ACT intervention of 6 sessions is more effective than no intervention in improving other functional outcomes among children and AYAs with chronic conditions, 3) Evaluate if a web-based group ACT intervention of 6 sessions improves participants skills in psychological flexibility, mindfulness, and cognitive defusion. Study population: Children and Adolescents/Young Adults (ages 14-21) diagnosed with a chronic medical condition seeking care at Children's Hospital Los Angeles, who are in the normal range of development and are eligible to participate in the study. Study Methodology: The study is a non-blinded, randomized, controlled trial designed to examine the effect of a web-based group ACT intervention on stress, depression, anxiety, health-related quality of life, and adaptive psychological skills in children and AYAs with chronic conditions. Statistical analysis: The primary analysis will involve a two independent samples t-test to compare the mean 6-week PSS scores between the two treatment groups. Secondary analyses will compare treatment groups on other study outcomes.

Official Title
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Virtual Acceptance Commitment Therapy (ACT): A Randomized Controlled Trial to Evaluate a Web-Based Intervention for Stress in Adolescents With Chronic Conditions

Conditions
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Chronic Illness

Intervention / Treatment
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* Behavioral: Virtual Acceptance Commitment Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Children: 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 Inclusion criteria for caregivers: Must be 18 years or older and legal guardian of enrolled child English or Spanish speaking, with an ability to read in their language Exclusion criteria for children: 1. Known developmental delay that precludes the ability to complete questionnaires or participate in group therapy

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (Immediate)<br>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<br>* 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.<br>|
| Other: Control (Waitlist)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Change via the Faces Pain Scale-Revised (FPS-R) | Revised is an updated version of the Wong-Baker Faces Pain Rating Scale depicting no pain as a neutral expression as compared with the smiling face of the original measure. The child is asked to point to the face cartoon that depicts how the patients are currently feeling because of their pain. Face measures are thought to measure pain intensity, and the Wong-Baker Faces measure has demonstrated good reliability and validity. | 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) | Parent Rating Scales (PRS) will be used to asses the child's behaviors and emotions. Parents evaluate 173 items on a never, sometimes, often, almost always scale. This is scored using a computer software purchased through Pearson. The raw score is converted to a T-score based on age and gender. The T-score has a mean of 50 and standard deviation of 10. T-scores above 65 are clinically significant in that domain. | 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) | PROMIS-25 measures quality of life (i.e., depression, anxiety, and pain interference). The 25 items are on a 1-5 scale and are scored using the HealthMeasures Scoring Service with higher scores indicating a lower quality of life. | 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) | This 18-item measure utilizes a three-point Likert scale (none (1), some (2), a lot (3)) to assess how negatively patients view anxiety symptoms. Items are summed with a higher score indicating greater anxiety sensitivity. | 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) | This 4-item measure uses 0-4 scale (0 = Not at All True; 4 = Very True) with lower sores correlating with higher psychological flexibility. | baseline at the start of study and change from baseline at 6 weeks | 
| Assess Change via Avoidance and Fusion Questionnaire Youth (AFQ-Y) | This 4-item measure uses 0-4 scale (0 = Not at All True; 4 = Very True) with higher sores correlating with higher psychological inflexibility. | baseline at the start of study and change from baseline at 6 weeks | 
| Assess Change via the Child and Adolescent Mindfulness Measure (CAMM) | This 10-item measure uses a 0-4 scale (0 = Not at All True; 4 = Very True) with lower scores correlating to greater mindfulness practices. | baseline at the start of study and change from baseline at 6 weeks | 
| Assess Change via the Brief Experiential Avoidance Questionnaire (BEAQ) | 15-item measure uses a 1-6 scale (1= strongly disagree; 6 = strongly agree) with higher scores associated with higher levels of avoidance and psychopathology | baseline at the start of study and change from baseline at 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Therapy, Group Therapy, Chronic Medical Condition, Adolescent