Clinical trial NCT04978610: Virtual ACT for Adolescent Stress
Official title: Virtual Acceptance Commitment Therapy (ACT): A Randomized Controlled Trial to Evaluate a Web-Based Intervention for Stress in Adolescents With Chronic Conditions
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Chronic Illness
Keywords: Virtual Therapy
Group Therapy
Chronic Medical Condition
Adolescent
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 144
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria for Children:

1. Children who are English speaking
2. 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).
3. Children with access to a device with internet and webcam capabilities
4. Children with access to a private setting to participate in the intervention

Inclusion criteria for caregivers:

1. Must be 18 years or older and legal guardian of enrolled child
2. 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

Primary outcomes:
measure: Assess Change via the Perceived Stress Scale (PSS)
timeFrame: 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:
measure: Assess Change via the Faces Pain Scale-Revised (FPS-R)
timeFrame: 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
measure: Assess Change via the Behavior Assessment System for Children, Third Edition (BASC-3)
timeFrame: baseline at the start of study and change from baseline at 6 weeks
measure: Assess Change via the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 v2.0 (PROMIS-25)
timeFrame: baseline at the start of study, change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks
measure: Assess Change via the Comprehensive Adolescent Severity Inventory (CASI)
timeFrame: baseline at the start of study, change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks
measure: Assess Change via the Acceptance and Action Questionnaire (AAQ-II)
timeFrame: baseline at the start of study and change from baseline at 6 weeks
measure: Assess Change via Avoidance and Fusion Questionnaire Youth (AFQ-Y)
timeFrame: baseline at the start of study and change from baseline at 6 weeks
measure: Assess Change via the Child and Adolescent Mindfulness Measure (CAMM)
timeFrame: baseline at the start of study and change from baseline at 6 weeks
measure: Assess Change via the Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: baseline at the start of study and change from baseline at 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Jeffrey Gold, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Los Angeles
name: Nicole Mahrer, PhD
role: PRINCIPAL_INVESTIGATOR
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