Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Percentage of participants who withdraw from course |
The study records will indicate withdrawal status (Yes or No) for each enrolled participant who has attended at least 1 intervention session; Calculated by: number who withdraw/total number enrolled X 100 |
Across 6 weeks of intervention |
|
| Primary |
Percentage of participants who attend at least 4 of 6 intervention sessions |
The study records will indicate weekly attendance at each session (Yes or No) for each enrolled participant who has attended at least 1 intervention session. Calculated by: number who attend at least 4 of 6 sessions/total number enrolled X 100 |
Across 6 weeks of intervention |
|
| Primary |
Percentage of participants who rate the course as "acceptable" or "completely acceptable" |
The Theoretical Framework of Acceptability includes 7-items regarding intervention acceptability on a scale of 1 to 5, scores range 7-35, higher numbers indicate greater acceptability. This general acceptability item will be used to assess overall acceptability of the course. Calculated by: number of participants who endorse "acceptable" or "completely acceptable"/total number of respondents X 100 |
6 weeks |
|
| Primary |
Percentage of intervention topics covered |
A research assistant in attendance will use a fidelity checklist to assess if intended topics are covered each session (Yes/No). Calculated by number of topics covered/total number of topics intended to be covered X 100 |
Across 6 weeks of intervention |
|
| Secondary |
Mean Change in Perceived Stress as Measured by the Perceived Stress Scale (PSS-10 item) at 6 weeks |
The PSS is a validated 10 item scale assessing the degree to which situations in one's life are perceived as stressful assessed over the last 7 days; scale ranges from 0=never to 4=very often; total scores range from 0 to 40 with higher scores indicating higher stress. |
Baseline and 6 weeks |
|
| Secondary |
Mean Change in Resilience as measured by the Connor-Davidson Resilience Scale-10 at 6 weeks |
The Connor-Davidson Resilience Scale is an 10-item measure of resilience and hardiness. Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Each item has a minimum score of 0 and a maximum score of 4, total scores range from 0 to 40, and higher scores indicate higher resilience. |
Baseline and 6 weeks |
|
| Secondary |
Mean Change in Anxiety as measured by the PROMIS-SF 7-item Anxiety Scale at 6 weeks |
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1. 0 - Anxiety 7a questionnaire includes 7 questions related to anxious mood in the past 7 days. Each question is rated on a five-point scale from 1=Never to 5=Always, with total scores ranging from 7-35 and higher scores indicating higher anxiety levels. |
Baseline and 6 weeks |
|
| Secondary |
Mean Change in Depressive symptoms as measured by the PROMIS-SF 8-item Depression Scale at 6 weeks |
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Depression scale measures depressive symptoms in the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. |
Baseline and 6 weeks |
|
| Secondary |
Mean Change in Self-Compassion as measured by the Self-Compassion Scale-Short form (SCS-SF) at 6 weeks |
The SCS-SF is a 12 item scale that measures how often one is self-compassionate. Each item is rated on a 5-point scale from 1=almost never to 5=almost always with a range in score from 8 to 40 with higher scores indicating greater frequency of self-compassion. |
Baseline and 6 weeks |
|
| Secondary |
Mean Change in Caregiver Burden as measured by the 12-item Zarit Caregiver Burden Scale (ZBI-12) at 6 weeks |
The ZBI-12 is a 12 item scale measuring caregiver burden. Each item is rated from 0 (never) to 4 (nearly always) with a range from 0 to 48 and higher scores indicating higher burden. |
Baseline and 6 weeks |
|
| Secondary |
Mean Change in Caregiver Uplifts as measured by the Uplifts subscale of the Revised Burden Measure at 6 weeks |
The Uplifts subscale measures positive aspects of caregiving using 6 items answered in a 5-point response scale ranging from 1 (Not at all) to 5 (A great deal). Scores range from 6-30, with higher scores indicating higher degrees of positive experiences in caregiving. |
Baseline and 6 weeks |
|
| Secondary |
Mean Change in Difficulties with Emotion Regulation as measured by the Difficulties in Emotion Regulation-Short Form Scale |
The Difficulties in Emotion Regulation scale measures difficulties with regulation of emotions using 18-items representing 6 subscales (strategies, nonacceptance, impulse, goals, awareness and clarity) answered in a 5-point response scale ranging from 1 (Almost never) to 5 (almost always). Total scores range from 18- 90 with higher scores indicating higher levels of difficulty with emotion regulation. |
Baseline and 6 weeks |
|
