An interventional study of Brief Internet-based Behavioral Activation Intervention in Brain Tumor, Pediatric, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Supportive care
The purpose of this study is to evaluate the effectiveness of an Internet-based, behavioral activation intervention to promote well-being in a young adult survivors of childhood brain tumor.
Participants will be recruited through the Children's Brain Tumor Foundation who will share the study announcement with their young adult members and social media. Eligible participants will complete a baseline battery survey via Qualtrics. The investigators will recruit 120 participants. The survey will take approximately 30 minutes to complete. Participants will be randomly assigned to an experimental group or control group. The experimental group will take an Internet-based behavioral activation intervention. The intervention has four modules and will be administered via Qualtrics. A link to each module will be sent to the participants via e-mail. Participants will have one week to complete each module. Once a participant completes a module, the next module link will be sent after 3 days. A reminder will be sent at 7 days and 10 days until the module is complete. Each module will take approximately 30 minutes to complete. The experimental group may continue to receive services as usual from the Children's Brain Tumor Foundation. The control group will continue to receive services as usual from the Children's Brain Tumor Foundation. The control group will have an opportunity to take the intervention once data collection is complete. Both groups will be asked to complete a battery of surveys at the end of the intervention and intermittently over a 3-month period.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 139 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be asked to complete a brief online program over a 4 to 8-week period. Each week participants will be asked to complete one session of the program online. There are four sessions.
Behavioral: Brief Internet-based Behavioral Activation Intervention
Participants will receive no intervention from the investigators. Participants may continue services as usual as provided by Children's Brain Tumor Foundation.
A brief Internet-based behavioral activation intervention consisting of 4 sessions.
Also known as: Taking Action and Making Commitment: A Well-being Prorgram
Change from baseline PERMA-Profiler score at 2 weeks and 3 months
The PERMA-Profiler is a general measure of well-being (Butler \& Kern, 2016). The PERMA-Profiler measures Seligman's (2011) five pillars of well-being: positive emotion, engagement, relationships, meaning, and accomplishment. The measure consists of 23 items, including three items for each domain. The health, negative emotion, loneliness, and overall happiness items act as filler questions and provide more information. Items are rated on an 11-point Likert scale ranging from 0 (never) to 10 (always), or 0 (not at all) to 10 (completely). Scores are calculated as the average of the items comprising each factor. Butler and Kern (2016) suggested that the multidimensional structure be retained, rather than condensing responses; however, a single well-being score may provide a global indication of well-being. Therefore, for the current study, total scores for each subscale will be calculated as well as the total scores. Change from baseline total score will be assessed.
Time frame: At baseline; 2 weeks and 3 months after completing the intervention.
Change from baseline World Health Organization-Disability Assessment Schedule 2.0 score at 2 weeks and 3 months
Measures overall health, functioning, and disability. Total scores range from 0 to 24. Scores are summed with higher scores indicating greater functional disability severity.
Time frame: At baseline; 2 weeks and 3 months after completing the intervention.
Change from baseline Life Satisfaction Scale (LiSat-9) score at 2 weeks and 3 months
To measure satisfaction with life, the Life Satisfaction Questionnaire (LiSat-9; Fugl-Meyer et al., 1991) will be included. The LiSat-9 has 9 items; including one general life satisfaction item. There 8 are domain-specific items for vocational situation, financial situation, leisure, contact friends, sexual life, activities of daily living, family life, and partnership relationship. Items are rated on an Likert scale ranging from 1 (very dissatisfying) to 6 (very satisfying). Scoring consists of calculating the mean score. Higher scores indicate greater satisfaction with life.
Time frame: At baseline; 2 weeks and 3 months after completing the intervention.
Change in baseline Perceived Stress Scale score at 2 weeks and 3 months
To measure perceived stress, the Perceived Stress Scale (PSS; Cohen \& Williamson, 1988) will be used. The PSS is a widely used 10-item scale in which respondents rate how stressful (unpredictable, uncontrollable, and overloaded) they perceive their lives to have been within the past month. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scoring consists of calculating the mean score. Higher scores indicate greater perceived stress.
Time frame: At baseline; 2 weeks and 3 months after completing the intervention.
Change in baseline Acceptance and Action Questionnaire (AAQ-II) score at 2 weeks and 3 months
The Acceptance and Action Questionnaire (AAQ-II) (Bond et al., 2011) consists of seven items to be answered on a scale of 1 (never true) to 7 (always true). The AAQ-II measures participants' willingness to live in accordance with their values, in contact with negative private events, and acceptance of these events. A higher total score indicates a higher level of psychological flexibility, that is higher acceptance and less experiential avoidance. Total mean score will be calculated.
Time frame: At baseline; 2 weeks and 3 months after completing the intervention.
Change in baseline Behavioral Activation for Depression Scale (BADS-9) score at 2 weeks and 3 months
The Behavioral Activation for Depression Scale- Short Form (BADS-9) is a 9-item scale with scores ranging from 0 to 54, with high scores representing higher activation. Total mean scores will be calculated.
Time frame: At baseline; 2 weeks and 3 months after completing the intervention.
Change in baseline Cognitive-Behavioral Social Self-Efficacy Scale score at 2 weeks and 3 months
The Cognitive-Behavioral Social Self-Efficacy Scale is an 18-item measure of perceived social self-efficacy. Item scores range from 1 (not confident at all) to 5 (very confident. Total scores range from 18 to 90, with higher scores representing greater perceived social self-efficacy. Total mean scores will be calculated.
Time frame: At baseline; 2 weeks and 3 months after completing the intervention.
Change in baseline Vocational Outcomes Expectancy Scale score at 2 weeks and 3 months
The Vocational Outcome Expectancy Scale (VOES) measures outcome expectancy related to employment. It is an 11-item scale with item scores ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 11 to 55, with higher scores representing a greater expectation of attaining positive employment outcomes (i.e., obtaining or retaining employment). Total mean scores will be calculated.
Time frame: At baseline; 2 weeks and 3 months after completing the intervention.
Change in baseline Perceived Barrier Scale score at 2 weeks and 3 months
The Perceived Career Barriers measure was developed to identify barriers to career development and employment of young adult survivors of pediatric brain tumors (Strauser et al., 2018). The 12-item measure uses an 11-point Likert Scale (0-10) with 0 being (not a barrier) and 10 being a (major barrier). A midpoint label of (somewhat of a barrier) is utilized. Total scores range from 0 to 110, with higher scores indicating greater perceived career barriers.
Time frame: At baseline; 2 weeks and 3 months after completing the intervention.
Change in baseline General Self-Efficacy Scale score at 2 weeks and 3 months
The General Self-Efficacy Scale (GSES) is a measure of general self-efficacy. It is a 10-item measure with item scores ranging from 1 (not true at all) to 4 (exactly true). Total scores range between 10 and 40, with a higher score indicating more self-efficacy.
Time frame: At baseline; 2 weeks and 3 months after completing the intervention.
Plan to share: No
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University of Wisconsin, Madison