Trial Outcomes & Findings for Supporting Our Caregivers In ADRD Learning (SOCIAL) (NCT NCT06276023)

82 participants provided informed consent and were enrolled in the study. 14 enrolled participants did not proceed to intervention assignment/start due to withdrawal, loss to follow-up prior to intervention/randomization. Therefore, 68 participants were randomized and started the intervention.

Supporting Our Caregivers In ADRD Learning (SOCIAL)

The proportion of eligible participants who are eligible and choose to enroll in the study and the percentage of racial and ethnically diverse participants enrolled.

The percentage randomized who complete the post-test.

The proportion of participants who completed the study and had fewer than 25% of all expected study questionnaires missing across the entire assessment period. This participant-level measure assessed overall study completion and questionnaire adherence.

Assessing whether at least 75% of participants completed every study question in the questionnaire (of note: no questionnaire in this study was entirely missing). The benchmark was met if no more than 25% of participants had one or more questionnaires that were completely missing.

The proportion of caregivers who attend at least 4 out of the 6 sessions out of all randomized caregivers. Adherence to treatment will be estimated for both HEP and MASC.

PGIC is a 7-point scale depicting a participant's rating of overall improvement. Participants rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse" or "very much worse"

The 'Perceptions of Questionnaire Battery' qualitative measure assesses how appropriately the participants fill the questionnaires, address their perception of stress, emotional distress and all other questionnaires.

The proportion of participants who complete more than 50% weekly home practice.

Participants' perception of emails and text messages reminders. The single question -, "Do participants think that the number of emails/texts received was: too little, just enough, too much?"

The Credibility and Expectancy Questionnaire (CEQ) assesses participants' perceptions that the treatment will work after participating in the intervention. It consists of 6 items divided into two subscales, with scoring is based on dividing the items into Credibility and Expectancy. Items 1-3: Assess Treatment Credibility, scored on a 1 to 9 scale (where 1 represents "not at all" and 9 represents "very much"; the subscale score is the sum of these three items, range: 3-27; a higher score indicates a better outcome). Items 4-6: Assess Treatment Expectancy, scored on a 0% to 100% scale (values are recoded to match the 1 to 9 scale of the previous items; once recoded, values range from 3-27; higher scores represent a better outcome). Credibility Score: Calculate the sum (or average) of items 1-3; a higher score indicates a better outcome. Expectancy Score: Calculate the sum (or average) of items 4-6; a higher score indicates a better outcome.

The Modified Perception of Global Improvement (MPGI) is a global index designed to measure a participant's interpretation of changes in perceptions of stress following intervention. The MPGI uses a 7-point Likert scale, with 1 = Very Much Improved and 7 = Very Much Worse (lower score represents a better outcome). For the data below, the scores were converted as follows: Improved - original scores of 1-3 converted to a zero Not improved - original score 4-7 converted to a 1. The averages of the converted scores were computed, with a score ranging from 0-1 (with a lower score representing a better outcome).

The investigators will use the Client Satisfaction Questionnaire (CSQ-3) to assess participants' satisfaction with the intervention. Each of the three questions is scored on a 4-point Likert scale ranging from 1 to 4, where higher numbers indicate greater satisfaction. To calculate the score, you add up the responses from the three questions. Total Score Range: 3 to 12 (higher score represents better outcome).

Ability of therapist to deliver the content of each session (through therapist completed adherence checklists) and therapist fidelity (through independent review of recorded sessions by Co-Investigator). To measure this outcome, recorded sessions were analyzed.

Center for Epidemiological Studies-Depression Scale (CES-D). The CES-D is a 20-item scale widely used with Alzheimer's Disease and Related Dementias (ADRD) participants. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time) In scoring the CES-D, possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology.

The Applied Mindfulness Process Scale (AMPS) is a process measure used to quantify how participants in mindfulness-based interventions (MBIs) use mindfulness practice when facing challenges in daily life. The AMPS yields 15 items representing three domains of applied mindfulness processes: (a) decentering, (b) positive emotional regulation, and (c) negative emotional regulation. AMPS is scored by adding all 15 items to obtain a score ranging from 0-60, with higher scores indicating higher use of mindfulness.

The Perceived Stress Scale 10 (PSS-10) assesses perceived stress using a 5-point Likert scale. The total score is determined by adding together the scores of each of the four items. Questions 2 and 3 are reverse coded. Questions 1 and 4: 0 = Never; 1 = Almost never; 2 = Sometimes; 3 = Fairly often; 4 = Very often Questions 2 and 3: 4 = Never; 3 = Almost never; 2 = Sometimes; 1 = Fairly often; 0 = Very often. Scores range from 0 to 40 with higher scores indicating more stress.

The State Trait Anxiety Inventory (STAI) state subscales (20 items) assesses anxiety symptoms in response to stressful situations. The range of possible scores varies from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

The Self-Compassion Scale - Short Form (SCS-SF) is a 12-item self-report measure that is used by adults to measure their capacity for self-compassion - the ability to hold one's feelings of suffering with a sense of warmth, connection and concern. All 12 items are scored using a 5-point Likert scale. Before calculating the final score, the following items are reverse-scored so that higher totals always reflect greater self-compassion: negative items that measure harsh self-criticism, isolation, and over-identification (Items 1, 4, 8, 9, 11, 12). Higher scores here indicate a more critical and reactive stance under stress. Positive items that measure self-kindness, common humanity, and mindfulness (Items 2, 3, 5, 6, 7, 10) are left untouched; higher scores mean a warmer, more accepting stance. The finalized 12 scored are summed (the reverse-scored numbers plus the untouched numbers) and divided by 12, for an average overall score between 1.0 and 5.0 with 5 indicating higher SC.

The Compassion Scale (CS) has 16 items assessing common humanity, kindness toward others and ability to understand the suffering or challenges of others, all items scored using a 5 point Likert scale. The items are grouped into 4 categories: Kindness (Items 2, 6, 10, 14), Common Humanity (Items 4, 8, 12, 16), Mindfulness (Items 1, 5, 9, 13), Indifference (Items 3, 7, 11, 15). Indifference items are reverse scored so that a higher number corresponds to higher compassion. The mean of each subscale is calculated. The, using the reverse-coded indifference scores and untouched scores, the grand mean of all 16 items to get the overall compassion score. Total scores will range from 1.0 to 5.0, where higher scores indicate greater overall compassion.

The Revised Caregiver Self-efficacy (RSCSE), assessing domains of self-efficacy including obtaining respite, responding to disruptive patient behaviors and controlling upsetting through, is a 15-item inventory with scores calculated as the mean across items, with higher scores indicating greater self-efficacy. There are 3 5-item subscales: Self-Efficacy for Obtaining Respite, Self-Efficacy for Responding to Disruptive Behaviors, and Self-Efficacy for Controlling Upsetting Thoughts. Each item is rated on a scale from 0-100. The subscale score is calculated by taking the mathematical average of the items within a specific subscale (0 to 100). The total score is calculated by taking the mathematical average of the non-missing items within a specific subscale (0 to 100).

The University of California, Los Angeles (UCLA) 3-item loneliness scale assesses relational connectedness, social connectedness and self-perceived isolation. The scores for each individual question can be added together to give participants a possible range of scores from 3 to 9. Researchers in the past have grouped people who score 3 - 5 as "not lonely" and people with the score 6 - 9 as "lonely".

The Interpersonal Support Evaluation List short form (ISEL) is a 12-item measure of perceptions of social support. Each of the 12 items is rated on a 4 point Likert scale from 0-3. Items are separated into subscales as follows: Appraisal Support (Items 2, 4, 6, 11), Belonging Support (Items 1, 5, 7, 9) and Tangible Support (Items 3, 8, 10, 12). Negative items (1, 2, 7, 8, 11, 12) are reverse coded. All 12 item scores are summed together, including reverse coded and untouched items, to get a score from 0-36, with higher total scores indicating a stronger perception of available social support.

The World Health Organization-Five Well-Being Index (WHO-D) has 5 items assessing emotional well-being. The raw score is calculated by totaling the figures of the five answers. The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.

The Neuropsychiatric Inventory (NPI) Caregiver Distress Scale has 12 items assessing distress associated with dementia patient's behaviors such as apathy, elation, disinhibition. Participant distress is rated for each positive neuropsychiatric symptom domain on a scale anchored by score from 0 to 5 points. The Score is: 0 = Not distressing at all, 1 = Minimal (slightly distressing, not a problem to cope with), 2 = Mild (not very distressing, generally easy to cope with), 3 = Moderate (fairly distressing, not always easy to cope with), 4 = Severe (very distressing, difficult to cope with), 5 = Extreme of Very Severe (extremely distressing, unable to cope with). The scores are added up for all 12 items, and the final score reported below ranges from 0-60 (a lower score indicates lower levels of stress and a better outcome).

The Dyadic Relationship Scale (DRS) (11 items) assesses negative and positive dyadic interactions between caregivers and their care recipient. Each item is rated on four-point scale (0-3) and responses are summed for a total score. Possible scores range from 0 to 33 with higher scores indicating higher levels of strain and positive interaction.