Trial Outcomes & Findings for The Family Cognitive Adaptation Training Manual: A Test of Effectiveness (NCT NCT01768000)
NCT ID: NCT01768000
Last Updated: 2016-03-01
Results Overview
The Multnomah Community Ability Scale (MCAS; Barker et al., 1994) is a 17-item scale assessing functionality in four domains - health, adaptation, social skills and behaviour. Ratings are made on the basis of an interview with the patient and their family member. The MCAS generates a total score ranging from 17 to 85. Items on the MCAS are scored on a five-point scale. The four total domain scores ranges are - health, 5-25; adaptation, 3-15; social skills, 5-25; behaviour, 4-20. Lower ratings indicate less ability. Higher ratings usually mean an assessment of greater ability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
4 months following baseline assessment
Results posted on
2016-03-01
Participant Flow
Recruited between March 2013 and February 2014 in Ontario, Canada.
Participant milestones
| Measure |
Family Cognitive Adaptation Training - Caregivers
Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
|
Control Group - Caregivers
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
|
Family Cognitive Adaptation Training - Family Members
Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
|
Control Group - Family Members
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
8
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Family Cognitive Adaptation Training Manual: A Test of Effectiveness
Baseline characteristics by cohort
| Measure |
Family Cognitive Adaptation Training - Family Members
n=10 Participants
Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
|
Family Cognitive Adaptation Training - Caregivers
n=10 Participants
Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
|
Control Group - Family Members
n=9 Participants
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
|
Control Group - Caregivers
n=9 Participants
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian East
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian South
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian South East
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black Canadian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Latin American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White Canadian
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White European
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian (not specified)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not specified
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
38 participants
n=21 Participants
|
|
Employment status
Full-time
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Employment status
Part-time
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Employment status
In school
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Employment status
Unemployed
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
1 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Employment status
Retired
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Employment status
Contract work
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Employment status
Not specified
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Level of education
Completion of graduate school
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Level of education
Completion of undergraduate university/college
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Level of education
Partial undergraduate university/college
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
0 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Level of education
Completion of high school
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Level of education
Partial high school
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Level of education
Not specified
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Housing
Own/rent apartment or home
|
0 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
|
Housing
Supported housing
|
1 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
|
Housing
Live with family
|
9 Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 months following baseline assessmentThe Multnomah Community Ability Scale (MCAS; Barker et al., 1994) is a 17-item scale assessing functionality in four domains - health, adaptation, social skills and behaviour. Ratings are made on the basis of an interview with the patient and their family member. The MCAS generates a total score ranging from 17 to 85. Items on the MCAS are scored on a five-point scale. The four total domain scores ranges are - health, 5-25; adaptation, 3-15; social skills, 5-25; behaviour, 4-20. Lower ratings indicate less ability. Higher ratings usually mean an assessment of greater ability.
Outcome measures
| Measure |
Family Cognitive Adaptation Training - Caregivers
n=9 Participants
Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
|
Control Group - Caregivers
n=9 Participants
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
|
Family Cognitive Adaptation Training - Family Members
n=8 Participants
Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
|
Control Group - Family Members
n=8 Participants
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
|
|---|---|---|---|---|
|
Multnomah Community Ability Scale (MCAS)
Total
|
67.78 units on a scale
Standard Deviation 5.70
|
74.63 units on a scale
Standard Deviation 5.45
|
70.00 units on a scale
Standard Deviation 5.10
|
74.38 units on a scale
Standard Deviation 5.15
|
|
Multnomah Community Ability Scale (MCAS)
Health
|
21.67 units on a scale
Standard Deviation 2.34
|
22.13 units on a scale
Standard Deviation 2.36
|
21.56 units on a scale
Standard Deviation 1.88
|
21.50 units on a scale
Standard Deviation 1.93
|
|
Multnomah Community Ability Scale (MCAS)
Adaptation
|
10.89 units on a scale
Standard Deviation 2.57
|
13.25 units on a scale
Standard Deviation 1.67
|
11.78 units on a scale
Standard Deviation 1.92
|
13.00 units on a scale
Standard Deviation 1.69
|
|
Multnomah Community Ability Scale (MCAS)
Social Skills
|
17.44 units on a scale
Standard Deviation 3.17
|
20.63 units on a scale
Standard Deviation 2.50
|
18.33 units on a scale
Standard Deviation 3.87
|
20.75 units on a scale
Standard Deviation 2.71
|
|
Multnomah Community Ability Scale (MCAS)
Behaviour
|
17.78 units on a scale
Standard Deviation 1.72
|
18.63 units on a scale
Standard Deviation 1.77
|
18.33 units on a scale
Standard Deviation 1.80
|
19.13 units on a scale
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: 4 months following baseline assessmentThe Brief Adherence Rating Scale (BARS; Byerly et al., 2008) is a 4-item, valid, reliable, sensitive, measure with which to obtain specific estimates of antipsychotic medication adherence of outpatients with schizophrenia. A total percentage score on a scale ranging from 0 to 100, with 0 indicating less adherence and 100 total adherence.
Outcome measures
| Measure |
Family Cognitive Adaptation Training - Caregivers
n=9 Participants
Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
|
Control Group - Caregivers
n=9 Participants
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
|
Family Cognitive Adaptation Training - Family Members
n=8 Participants
Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
|
Control Group - Family Members
n=8 Participants
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
|
|---|---|---|---|---|
|
Brief Adherence Rating Scale (BARS)
|
77.22 units on a scale
Standard Deviation 35.98
|
87.50 units on a scale
Standard Deviation 35.36
|
59.33 units on a scale
Standard Deviation 44.03
|
88.75 units on a scale
Standard Deviation 31.82
|
SECONDARY outcome
Timeframe: 4 months following baseline assessment8 out of 18 items from the Satisfaction With Life Scale (Test et al., 2005) will measure the perceived quality of life of the individual with schizophrenia by tapping into global satisfaction in domains relevant to CAT (e.g., How satisfied are you with yourself on the whole? - 5 point scale, not at all - great deal). This scale is well-validated with a schizophrenia population and is being shortened as not all items are relevant to CAT nor expected to be sensitive to change in a 4 month period, and there is a need to abbreviate the battery to reduce the risk of fatigue in a lengthy phone interview. These 8 items comprise four domains of social relationships, employment/work, social and present life and living situation. A low score indicates less satisfaction in these domains and a higher score indicating greater satisfaction. Total scores can range from 8-40 and subscale scores range from 1-5.
Outcome measures
| Measure |
Family Cognitive Adaptation Training - Caregivers
n=9 Participants
Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
|
Control Group - Caregivers
n=8 Participants
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
|
Family Cognitive Adaptation Training - Family Members
Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
|
Control Group - Family Members
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
|
|---|---|---|---|---|
|
Satisfaction With Life Scale
Social Relationships
|
2.06 units on a scale
Standard Deviation 0.92
|
2.18 units on a scale
Standard Deviation 0.73
|
—
|
—
|
|
Satisfaction With Life Scale
Employment/Work
|
1.63 units on a scale
Standard Deviation 1.16
|
2.17 units on a scale
Standard Deviation 0.41
|
—
|
—
|
|
Satisfaction With Life Scale
Social & Present Life
|
2.00 units on a scale
Standard Deviation 0.99
|
2.29 units on a scale
Standard Deviation 0.76
|
—
|
—
|
|
Satisfaction With Life Scale
Living Situation
|
3.11 units on a scale
Standard Deviation 0.49
|
3.00 units on a scale
Standard Deviation 0.66
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 months following baseline assessmentThe 31-item Involvement Evaluation Questionnaire (IEQ; Van Wijngaarden et al., 2000) measures caregiver burden. It has been validated for caregivers of individuals with schizophrenia, covers a broad domain of caregiving consequences and refers to burden experienced within the past 4 weeks. Mean scores are calculated for the total scale and sub-scales. Total scores can range from 29 to 145 with sub-scale domains ranging - tension, 9-45; supervision, 6-30; worrying, 6-30; and urging, 8-40. Lower total and subscale scores indicate less burden and higher scores greater level of caregiver burden.
Outcome measures
| Measure |
Family Cognitive Adaptation Training - Caregivers
n=9 Participants
Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
|
Control Group - Caregivers
n=8 Participants
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
|
Family Cognitive Adaptation Training - Family Members
Participants in this group will receive the Family CAT manual and DVD.
Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
|
Control Group - Family Members
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
|
|---|---|---|---|---|
|
Involvement Evaluation Questionnaire (IES)
Total
|
57.72 units on a scale
Standard Deviation 9.66
|
49.25 units on a scale
Standard Deviation 11.15
|
—
|
—
|
|
Involvement Evaluation Questionnaire (IES)
Tension
|
15.50 units on a scale
Standard Deviation 4.27
|
14.13 units on a scale
Standard Deviation 2.85
|
—
|
—
|
|
Involvement Evaluation Questionnaire (IES)
Supervision
|
8.22 units on a scale
Standard Deviation 2.05
|
7.50 units on a scale
Standard Deviation 1.07
|
—
|
—
|
|
Involvement Evaluation Questionnaire (IES)
Worrying
|
17.89 units on a scale
Standard Deviation 4.31
|
15.25 units on a scale
Standard Deviation 4.40
|
—
|
—
|
|
Involvement Evaluation Questionnaire (IES)
Urging
|
20.56 units on a scale
Standard Deviation 7.13
|
16.38 units on a scale
Standard Deviation 5.66
|
—
|
—
|
Adverse Events
Family Cognitive Adaptation Training - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Family Cognitive Adaptation Training - Family Members
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group - Family Members
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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