Trial Outcomes & Findings for Motivation and Skills Support (MASS) (NCT NCT03404219)
NCT ID: NCT03404219
Last Updated: 2021-08-10
Results Overview
The Social Functioning Scale (SFS; Birchwood, Smith, Cochrane, Wetton, and Copestake, 1990) is a validated measure of social functioning commonly used in schizophrenia research studies. This clinician-administered measure consists of 7 sub-scales where higher scores indicate better social functioning: Social Engagement/Withdrawal (7 items. Score range: 0-15), Interpersonal (5 items. Score range: 0-30), Prosocial (5 items. Score range: 0-66), Recreation (23 items. Score range: 0-48), Independence - competence (15 items. Score range: 0-39), Independence - performance (13 items. Score range: 0-39), and Employment (13 items. Score range is 0-6 if the participant is unemployed and 7-10 if the participant is employed). The total score is the sum of the 7 sub-scales (Possible range of 0-247) and higher scores indicate better functioning. The investigators will examine the difference in total score from baseline (study entry) to follow-up (3 months after study termination).
COMPLETED
NA
31 participants
Baseline (study entry) and follow-up (3 months post-intervention)
2021-08-10
Participant Flow
73 potential participants completed initial phone screen. 25 did not meet inclusion criteria based on age, neurological disorder status, recent hospitalization status, legal guardian status, or diagnosis. 48 participants were further screened. 10 of those participants did not meet inclusion criteria for diagnosis or substance use disorder status. 6 additional participants never initiated the intervention.
Participant milestones
| Measure |
Intervention Group
All participants were assigned to this group and received the intervention.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Motivation and Skills Support (MASS)
Baseline characteristics by cohort
| Measure |
Intervention Group
n=31 Participants
All participants were assigned to this group and received the intervention.
|
|---|---|
|
Age, Continuous
|
46.097 years
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
14 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
16 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Unknown
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (study entry) and follow-up (3 months post-intervention)Population: Participants with schizophrenia or schizoaffective disorder
The Social Functioning Scale (SFS; Birchwood, Smith, Cochrane, Wetton, and Copestake, 1990) is a validated measure of social functioning commonly used in schizophrenia research studies. This clinician-administered measure consists of 7 sub-scales where higher scores indicate better social functioning: Social Engagement/Withdrawal (7 items. Score range: 0-15), Interpersonal (5 items. Score range: 0-30), Prosocial (5 items. Score range: 0-66), Recreation (23 items. Score range: 0-48), Independence - competence (15 items. Score range: 0-39), Independence - performance (13 items. Score range: 0-39), and Employment (13 items. Score range is 0-6 if the participant is unemployed and 7-10 if the participant is employed). The total score is the sum of the 7 sub-scales (Possible range of 0-247) and higher scores indicate better functioning. The investigators will examine the difference in total score from baseline (study entry) to follow-up (3 months after study termination).
Outcome measures
| Measure |
Intervention Group
n=31 Participants
All participants were assigned to this group and received the intervention.
|
|---|---|
|
Changes in Social Functioning as Measured by the Social Functioning Scale (SFS)
|
108.00 score on a scale
Standard Deviation 7.13
|
PRIMARY outcome
Timeframe: Baseline (study entry) and follow-up (3 months post-intervention)The Heinrich Quality of Life Scale - Interpersonal Relations subscale (Heinrichs, Hanlon, \& Carpenter, 1984) is a validated measure of social engagement used in studies of schizophrenia. This clinician-administered measure consists of 8 items that address different facets of social engagement (e.g., social network, acquaintances, intimate relationships, social withdrawal). Possible scores range from 0-48 with higher scores indicating better outcomes. The investigators will administer this measure at baseline (study entry) and follow-up (3 months post-intervention).
Outcome measures
| Measure |
Intervention Group
n=31 Participants
All participants were assigned to this group and received the intervention.
|
|---|---|
|
Changes in Social Engagement as Measured by the Quality of Life Scale (QLS) - Interpersonal Relations Subscale.
|
2.60 score on a scale
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: 2 times per day for 2 months (intervention period).The investigators will ask participants to report on positive social appraisals (unpublished measure) of recent interactions 2 times per day over the 2-month intervention period. Specific items and response options are the following: 1. "How well do you think you communicated in those conversations?" (from 1 \[I did not communicate well at all\] to 4 \[I communicated very well\]) 2. "To what extent were those interactions worth the effort?" (from 1 \[not worth the effort at all\] to 4 \[definitely worth the effort\]) 3. "What do you think other people thought of you in those conversations?" with response options ranging from 1 \[very unlikable\] to 4 \[very likable\]) We will average scores on the above items across all available time points (total possible time points = 120) to form a composite variable representing social appraisals. Higher scores represent more positive appraisals. Investigators will examine changes in appraisals over the intervention.
Outcome measures
| Measure |
Intervention Group
n=31 Participants
All participants were assigned to this group and received the intervention.
|
|---|---|
|
Changes in Experience-Sampling-Based Self-Reports of Social Appraisals
|
1.35 score on a scale
Standard Deviation 0.64
|
Adverse Events
Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place