Development and Feasibility of a Lifestyle Group Intervention for Youth at Clinical High Risk for Psychosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Change in Subjective Stress
Study Overview
Brief Summary
The present study will assess the feasibility and social validity of an adjunctive health promotion group for youth and clinical high risk for psychosis (CHR-P). Youth participating in treatment at the Center for the Assessment and Prevention of Prodromal Sates (CAPPS) will be invited to participate in a weekly, adjunctive, closed psychoeducation group focused on sharing health promotion strategies and increasing health behaviors (e.g. improved sleep habits, increased participation in physical activity).
The aim of the group will be to provide psychoeducation on lifestyle risk and protective factors for youth at risk for psychosis (i.e. experiencing subthreshold psychosis symptoms). Topics covered will include psychoeducation, goal setting, stress management, sleep, physical activity, substance use, and nutrition. Evidence-based strategies to decrease risk factors and promote protective lifestyle factors for mental illness will be reviewed. Group leaders will utilize a motivational interviewing approach to facilitate the group.
The group will complete nine weekly group sessions. The goal of our research is to 1) determine the feasibility of a novel group-based health promotion intervention, 2) assess the social validity of the group, 3) measure the effects of the intervention on stress, sleep, physical activity, substance use, and nutrition, and 4) measure preliminary effects on symptoms and functioning.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •between 13 and 17 years old
- •able to sign and provide informed consent (assent for minors)
- •meet criteria for CHR-P using the Structured Interview for Psychosis-Risk Syndromes (SIPS).
- •Must have a primary caregiver willing to participate who speaks fluent English
Exclusion Criteria
- •current or lifetime DSM-5 psychotic disorder
- •impaired intellectual functioning (IQ <65)
- •history of neurological disorder
- •traumatic brain injury (≥7 on TBI screening tool)
- •significant substance use that makes CHR-P diagnosis ambiguous
Arms & Interventions
Health Behavior Group
9- week health behavior promotion group intervention
Intervention: Health Behaviors Group (Behavioral)
Outcomes
Primary Outcomes
Change in Subjective Stress
Time Frame: Change from baseline (pre-intervention) to 9- week post-intervention
Participant subjective stress will be assessed via the 10-item self-report Perceived Stress Scale ( PSS; Cohen et al., 1983).The PSS consists of 10 items rated 0= Never to 4= Very Often, with a higher score suggesting more stress.
Change in Diet
Time Frame: Change from baseline (pre-intervention) to 9- week post-intervention
Change in diet will be measured on the ASA24. This dietary assessment uses 24-hour recall to assess nutrition quality and provides measure of total energy intake and macronutrients.
Change in Physical Activity
Time Frame: Change from baseline (pre-intervention) to 9- week post-intervention
The mean profile from baseline to post-treatment for physical activity as assessed by the International Physical Activity Questionnaire - Short Form (IPAQ-SF; Craig et al., 2017). Activity levels will be self-report.
Change in Substance Use
Time Frame: Change from baseline (pre-intervention) to 9- week post-intervention
Alcohol and drug use will be measured by clinician rated on the Alcohol Use Scale and Drug Use Scale (AUS/DUS; Drake et al., 1996). This measure rates frequency and impairment associated with alcohol and drug use. Alcohol and drug use are rated on both frequency (0= no use to 5= almost daily) and impairment (0= abstinent to 5= dependence with institutionalization). A rating of 3 or higher on impairment corresponds with substance use disorder.
Change Sleep Habits
Time Frame: Change from baseline (pre-intervention) to 9- week post-intervention
Sleep will be assessed via self-report on the PROMIS Pediatric Sleep Disturbance scale (Buysse, et al., 2010). The Pediatric Sleep Disturbance Scale consists of 15 items rated 1 = Never, 2 = Almost Never, 3 = Sometimes, 4 = Almost Always, and 5 = Always, with a higher score indicating more sleep disturbance.
Participant Recruitment and Retention
Time Frame: Across Intervention: 9 weeks
Feasibility will be measured by recruitment (participants approached/ participants enrolled) and retention (participants enrolled/ participants completed at least two-thirds of the intervention). Feasibility data will be summarized by the percent recruited, the percent retained by group and the mean and median number of sessions attended by group. The percent who attended each session by group over time will also be reported. Good feasibility will be defined as 70% of those enrolled completing at least two-thirds of the intervention (6 sessions).
Secondary Outcomes
- Social Validity as assessed by the Semi-Structured Interview for Social Validation(9-week post-intervention)
Investigators
Bernalyn Ruiz-Yu, PhD
Postdoctoral Fellow
University of California, Los Angeles