Trial Outcomes & Findings for Pilot Study of Motivational Interviewing for Loved Ones (NCT NCT04010747)
NCT ID: NCT04010747
Last Updated: 2023-04-07
Results Overview
The participant will report the number of mental health related appointments attended by the IP during the past month via a structured survey.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
Change from Baseline to 12 weeks
Results posted on
2023-04-07
Participant Flow
Participant milestones
| Measure |
Motivational Interviewing for Loved Ones (MILO)
MILO consists of four sessions of "coaching" in communication skills called motivational interviewing. Participants meet with a trainer/therapist for each session. At the first session, participants learn about the ideas behind motivational interviewing. In the second session, participants practice motivational interviewing skills. In the third and fourth sessions, the participant and therapist discuss the participant's efforts to communicate with their loved one using MI skills. Participants will also be offered direct assistance with a referral to mental health treatment for their loved one.
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
|
Mental Health Services Consultation and Waitlist
This consultation will consist of a 30 minute appointment in which participants can speak with a clinician knowledgeable about psychosis treatment resources. He/she can recommend specific programs, educational websites, and/or support groups that might be relevant for the participant's family. Participants will then be placed on a 6-week waitlist, after which they will have the opportunity to participate in the active intervention (four sessions of MILO).
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
Mental Health Services Consultation and Waitlist: 1 session of individualized consultation on relevant mental health services for the IP and participating PCSO and 6 weeks on a waitlist, followed by opportunity to participate in MILO sessions.
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|---|---|---|
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Overall Study
STARTED
|
53
|
18
|
|
Overall Study
COMPLETED
|
53
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data are missing for 1 participant in the MILO group.
Baseline characteristics by cohort
| Measure |
Motivational Interviewing for Loved Ones (MILO)
n=53 Participants
MILO consists of four sessions of "coaching" in communication skills called motivational interviewing. Participants meet with a trainer/therapist for each session. At the first session, participants learn about the ideas behind motivational interviewing. In the second session, participants practice motivational interviewing skills. In the third and fourth sessions, the participant and therapist discuss the participant's efforts to communicate with their loved one using MI skills. Participants will also be offered direct assistance with a referral to mental health treatment for their loved one.
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
|
Mental Health Services Consultation and Waitlist
n=18 Participants
This consultation will consist of a 30 minute appointment in which participants can speak with a clinician knowledgeable about psychosis treatment resources. He/she can recommend specific programs, educational websites, and/or support groups that might be relevant for the participant's family. Participants will then be placed on a 6-week waitlist, after which they will have the opportunity to participate in the active intervention (four sessions of MILO).
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
Mental Health Services Consultation and Waitlist: 1 session of individualized consultation on relevant mental health services for the IP and participating PCSO and 6 weeks on a waitlist, followed by opportunity to participate in MILO sessions.
|
Total
n=71 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
57.1 years
STANDARD_DEVIATION 8.5 • n=53 Participants
|
60.1 years
STANDARD_DEVIATION 9.9 • n=18 Participants
|
57.9 years
STANDARD_DEVIATION 8.9 • n=71 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=53 Participants
|
12 Participants
n=18 Participants
|
51 Participants
n=71 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=53 Participants
|
6 Participants
n=18 Participants
|
20 Participants
n=71 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=53 Participants
|
3 Participants
n=18 Participants
|
7 Participants
n=71 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=53 Participants
|
1 Participants
n=18 Participants
|
4 Participants
n=71 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=53 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=71 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=53 Participants
|
13 Participants
n=18 Participants
|
55 Participants
n=71 Participants
|
|
Race/Ethnicity, Customized
Prefer not to state
|
2 Participants
n=53 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=71 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=53 Participants
|
18 Participants
n=18 Participants
|
71 Participants
n=71 Participants
|
|
Baseline mental health related appointments by the individual with psychosis (IP) in prior month
|
1.63 number of appointments
STANDARD_DEVIATION 1.62 • n=52 Participants • Data are missing for 1 participant in the MILO group.
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2.00 number of appointments
STANDARD_DEVIATION 1.78 • n=18 Participants • Data are missing for 1 participant in the MILO group.
|
1.73 number of appointments
STANDARD_DEVIATION 1.66 • n=70 Participants • Data are missing for 1 participant in the MILO group.
|
|
Baseline parents and concerned significant others (PCSO) expressed emotion
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54.74 score on a scale
STANDARD_DEVIATION 8.42 • n=53 Participants
|
54.83 score on a scale
STANDARD_DEVIATION 10.27 • n=18 Participants
|
54.76 score on a scale
STANDARD_DEVIATION 8.85 • n=71 Participants
|
|
Baseline parents and concerned significant others (PCSO) distress
|
19.47 score on a scale
STANDARD_DEVIATION 5.75 • n=53 Participants
|
19.50 score on a scale
STANDARD_DEVIATION 6.15 • n=18 Participants
|
19.48 score on a scale
STANDARD_DEVIATION 5.81 • n=71 Participants
|
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Baseline PCSO acquisition of motivational interviewing skills
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10.98 score on a scale
STANDARD_DEVIATION 4.46 • n=51 Participants • Data are missing for 2 participant in the MILO group.
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12.17 score on a scale
STANDARD_DEVIATION 5.44 • n=18 Participants • Data are missing for 2 participant in the MILO group.
|
11.29 score on a scale
STANDARD_DEVIATION 4.72 • n=69 Participants • Data are missing for 2 participant in the MILO group.
|
|
Baseline PCSO beliefs and self confidence to parent
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58.83 score on a scale
STANDARD_DEVIATION 11.99 • n=51 Participants • Data are missing for 2 participant in the MILO group.
|
55.21 score on a scale
STANDARD_DEVIATION 15.07 • n=18 Participants • Data are missing for 2 participant in the MILO group.
|
57.89 score on a scale
STANDARD_DEVIATION 12.85 • n=69 Participants • Data are missing for 2 participant in the MILO group.
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PRIMARY outcome
Timeframe: Change from Baseline to 12 weeksPopulation: There was missing data for 11 of the MILO and 1 of the Waitlist groups
The participant will report the number of mental health related appointments attended by the IP during the past month via a structured survey.
Outcome measures
| Measure |
Motivational Interviewing for Loved Ones (MILO)
n=42 Participants
MILO consists of four sessions of "coaching" in communication skills called motivational interviewing. Participants meet with a trainer/therapist for each session. At the first session, participants learn about the ideas behind motivational interviewing. In the second session, participants practice motivational interviewing skills. In the third and fourth sessions, the participant and therapist discuss the participant's efforts to communicate with their loved one using MI skills. Participants will also be offered direct assistance with a referral to mental health treatment for their loved one.
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
|
Mental Health Services Consultation and Waitlist
n=17 Participants
This consultation will consist of a 30 minute appointment in which participants can speak with a clinician knowledgeable about psychosis treatment resources. He/she can recommend specific programs, educational websites, and/or support groups that might be relevant for the participant's family. Participants will then be placed on a 6-week waitlist, after which they will have the opportunity to participate in the active intervention (four sessions of MILO).
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
Mental Health Services Consultation and Waitlist: 1 session of individualized consultation on relevant mental health services for the IP and participating PCSO and 6 weeks on a waitlist, followed by opportunity to participate in MILO sessions.
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|---|---|---|
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Change in the Number of Mental Health Related Appointments Attended by the Individual With Psychosis (IP) in the Past 30 Days
|
0.29 number of appointments
Standard Deviation 1.64
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-1.06 number of appointments
Standard Deviation 1.95
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SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksPopulation: There was missing data for 8 of the MILO and 1 of the Waitlist groups
Caregiver attitudes toward individual with psychosis; measured via 20-item "family questionnaire" (FQ). The FQ has is a 20 item scale with a total score range of 20-80. Higher scores indicate more expressed emotion (i.e. critical and over-involved attitudes toward family member).
Outcome measures
| Measure |
Motivational Interviewing for Loved Ones (MILO)
n=45 Participants
MILO consists of four sessions of "coaching" in communication skills called motivational interviewing. Participants meet with a trainer/therapist for each session. At the first session, participants learn about the ideas behind motivational interviewing. In the second session, participants practice motivational interviewing skills. In the third and fourth sessions, the participant and therapist discuss the participant's efforts to communicate with their loved one using MI skills. Participants will also be offered direct assistance with a referral to mental health treatment for their loved one.
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
|
Mental Health Services Consultation and Waitlist
n=17 Participants
This consultation will consist of a 30 minute appointment in which participants can speak with a clinician knowledgeable about psychosis treatment resources. He/she can recommend specific programs, educational websites, and/or support groups that might be relevant for the participant's family. Participants will then be placed on a 6-week waitlist, after which they will have the opportunity to participate in the active intervention (four sessions of MILO).
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
Mental Health Services Consultation and Waitlist: 1 session of individualized consultation on relevant mental health services for the IP and participating PCSO and 6 weeks on a waitlist, followed by opportunity to participate in MILO sessions.
|
|---|---|---|
|
Change in Parents and Concerned Significant Others (PCSO) Expressed Emotion
|
-7.82 score on a scale
Standard Deviation 10.46
|
-7.0 score on a scale
Standard Deviation 11.24
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksPopulation: There was missing data for 8 of the MILO and 1 of the Waitlist groups
Symptoms of depression, anxiety, and behavioral disorders experienced by the PCSO; measured via the Perceived Stress Scale (PSS). The PSS is a 10 item questionnaire with a total score range of 0-40. Higher total scores indicate higher stress.
Outcome measures
| Measure |
Motivational Interviewing for Loved Ones (MILO)
n=45 Participants
MILO consists of four sessions of "coaching" in communication skills called motivational interviewing. Participants meet with a trainer/therapist for each session. At the first session, participants learn about the ideas behind motivational interviewing. In the second session, participants practice motivational interviewing skills. In the third and fourth sessions, the participant and therapist discuss the participant's efforts to communicate with their loved one using MI skills. Participants will also be offered direct assistance with a referral to mental health treatment for their loved one.
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
|
Mental Health Services Consultation and Waitlist
n=17 Participants
This consultation will consist of a 30 minute appointment in which participants can speak with a clinician knowledgeable about psychosis treatment resources. He/she can recommend specific programs, educational websites, and/or support groups that might be relevant for the participant's family. Participants will then be placed on a 6-week waitlist, after which they will have the opportunity to participate in the active intervention (four sessions of MILO).
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
Mental Health Services Consultation and Waitlist: 1 session of individualized consultation on relevant mental health services for the IP and participating PCSO and 6 weeks on a waitlist, followed by opportunity to participate in MILO sessions.
|
|---|---|---|
|
Change in Parents and Concerned Significant Others (PCSO) Distress
|
-3.91 score on a scale
Standard Deviation 5.86
|
-4.47 score on a scale
Standard Deviation 7.48
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to 6 weeksPopulation: There was missing data for 8 of the MILO and 4 of the Waitlist groups
PCSO will attempt to demonstrate motivational interviewing (MI) skills in a recorded role play; role play will be scored using a modified Motivational Interviewing Treatment Integrity Scale. Scores can range from 0 (poor MI skills demonstration) to 20 (expert MI skills demonstration). Higher scores represent increased proficiency in motivational interviewing skills: giving information, persuading with permission, questioning, reflecting, affirming, seeking collaboration, and emphasizing autonomy.
Outcome measures
| Measure |
Motivational Interviewing for Loved Ones (MILO)
n=45 Participants
MILO consists of four sessions of "coaching" in communication skills called motivational interviewing. Participants meet with a trainer/therapist for each session. At the first session, participants learn about the ideas behind motivational interviewing. In the second session, participants practice motivational interviewing skills. In the third and fourth sessions, the participant and therapist discuss the participant's efforts to communicate with their loved one using MI skills. Participants will also be offered direct assistance with a referral to mental health treatment for their loved one.
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
|
Mental Health Services Consultation and Waitlist
n=14 Participants
This consultation will consist of a 30 minute appointment in which participants can speak with a clinician knowledgeable about psychosis treatment resources. He/she can recommend specific programs, educational websites, and/or support groups that might be relevant for the participant's family. Participants will then be placed on a 6-week waitlist, after which they will have the opportunity to participate in the active intervention (four sessions of MILO).
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
Mental Health Services Consultation and Waitlist: 1 session of individualized consultation on relevant mental health services for the IP and participating PCSO and 6 weeks on a waitlist, followed by opportunity to participate in MILO sessions.
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|---|---|---|
|
Change in Parents and Concerned Significant Others (PCSO) Acquisition of Motivational Interviewing Skills
|
5.09 score on a scale
Standard Deviation 3.67
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5.29 score on a scale
Standard Deviation 4.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to 6 weeksPopulation: There was missing data for 10 of the MILO and 1 of the Waitlist groups
This outcome will be measured via the Parenting Self Agency Measure and only completed by those who identified as parents. The scale has 10 items rated by a 0% "Never"-100% "Always" slider scale. Higher scores rare associated with more parenting confidence.
Outcome measures
| Measure |
Motivational Interviewing for Loved Ones (MILO)
n=43 Participants
MILO consists of four sessions of "coaching" in communication skills called motivational interviewing. Participants meet with a trainer/therapist for each session. At the first session, participants learn about the ideas behind motivational interviewing. In the second session, participants practice motivational interviewing skills. In the third and fourth sessions, the participant and therapist discuss the participant's efforts to communicate with their loved one using MI skills. Participants will also be offered direct assistance with a referral to mental health treatment for their loved one.
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
|
Mental Health Services Consultation and Waitlist
n=17 Participants
This consultation will consist of a 30 minute appointment in which participants can speak with a clinician knowledgeable about psychosis treatment resources. He/she can recommend specific programs, educational websites, and/or support groups that might be relevant for the participant's family. Participants will then be placed on a 6-week waitlist, after which they will have the opportunity to participate in the active intervention (four sessions of MILO).
Motivational Interviewing for Loved Ones (MILO): 4 sessions of behavioral coaching in motivational interviewing communication techniques
Mental Health Services Consultation and Waitlist: 1 session of individualized consultation on relevant mental health services for the IP and participating PCSO and 6 weeks on a waitlist, followed by opportunity to participate in MILO sessions.
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|---|---|---|
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Change in PCSO Beliefs and Self Confidence to Parent
|
5.59 score on a scale
Standard Deviation 12.66
|
12.12 score on a scale
Standard Deviation 13.13
|
Adverse Events
Motivational Interviewing for Loved Ones (MILO)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mental Health Services Consultation and Waitlist
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
Emily R Kline, PhD
Boston Medical Center & BU Chobanian & Avedisian School of Medicine
Phone: 401-206-0586
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place