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Pilot Study of Motivational Interviewing for Loved Ones

Pilot Study of Motivational Interviewing for Loved Ones

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04010747
Acronym
MILO-Pilot
Enrollment
71
Registered
2019-07-08
Start date
2020-03-01
Completion date
2022-04-30
Last updated
2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis, Psychotic Disorders, Psychotic Episode

Keywords

Parents, Family Members, Partner, Domestic

Brief summary

The study population for this research will include parents and concerned significant others (PCSO) of individuals experiencing recent (past five years) onset of a psychotic disorder (hereafter referred to as individuals with psychosis, IP) who are not currently engaged with, or at risk for disengagement from, treatment. MILO is a brief and structured intervention that teaches motivational interviewing communication strategies. The initial aim (phase 1) of this pilot study is to evaluate feasibility of the intervention. The secondary aims are to evaluate the effectiveness of MILO for (1) enhancing the engagement of IP with evidence-based treatments and (2) reducing distress among PCSO. The investigators hypothesize that the intervention will be superior to control condition for both enhancing IP engagement with mental health services and reducing PCSO distress.

Detailed description

First Episode Psychosis (FEP) often represents a time of crisis for young people and their families. Since peak onset occurs during late adolescence and early adulthood, the onset of serious mental health challenges can disrupt plans for education, relationships, and other milestones of independence. Although some psychoses are brief and self-limiting, more often these symptoms portend a potentially chronic and disabling psychiatric disorder such as schizophrenia. FEP can also be acutely dangerous: youth with FEP are far more likely to die in the year following their diagnosis relative to the general population of 16-30 year old's in the United States. Approximately 100,000 youth in the United States experience FEP every year. Young people identified by providers as experiencing FEP often slip through the cracks before they reach appropriate treatment. A review of privately insured adolescents and young adults in the US showed that 62% of young people in the US with FEP filled no outpatient prescriptions, and 41% received no outpatient psychotherapy, in the year following their index diagnosis. Among those who do have an initial encounter with specialized FEP outpatient care, high attrition is a common problem, with 30% of individuals initially enrolled in first episode programs dropping out prior to completing treatment. Many individuals experiencing psychosis are reluctant to seek mental health treatment due to lack of insight and fear of psychiatric interventions. Young adults may be torn between distress and dissatisfaction relating to their symptoms and functioning, and mistrust of mental health providers and irritation with their parents' concern. Motivational Interviewing (MI) techniques are designed to elicit this ambivalence through nonjudgmental listening, so that discrepancies between current behaviors and ideal outcomes can be explored. Clinician-delivered MI has been identified as effective for enhancing adherence once individuals with psychosis are involved in care, and may also be useful for engaging those who are not yet interested in treatment. Several studies have found positive results in training and deploying non-professionals to use MI to influence others' health behaviors. MI training for parents and concerned significant others (PCSO) is a promising venue through which PCSO can specifically influence their loved one's decision to seek care and adhere to treatment plans. MILO is a structured and goal oriented intervention that seeks to accomplish two aims. The primary aim is to facilitate the engagement of IP with evidence-based treatments. The secondary aim is to reduce the distress and increase the wellbeing of PCSO. The intervention will be trialed for feasibility (phase 1, n = 30) and then tested against a small treatment as usual (TAU) control arm (phase 2, n = 40). During phase 2, participants will be randomly assigned to either receive MILO (50%) or TAU (50%). The trial will involve a total of 70 participants.

Interventions

BEHAVIORALMotivational Interviewing for Loved Ones (MILO)

4 sessions of behavioral coaching in motivational interviewing communication techniques

BEHAVIORALMental 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.

Sponsors

Beth Israel Deaconess Medical Center
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Prior to the crossover the study will be open label. After the crossover, the outcome assessor will be blinded to study condition.

Intervention model description

The first 30 participants to enroll in this study will receive a training intervention called Motivational Interviewing for Loved Ones (MILO). After that, participants will be randomly assigned to the intervention (MILO) or to a control condition involving a 30-minute mental health services consultation and a 6 week waitlist followed by the opportunity to participate in the MILO intervention (Phase 2)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 or older * Primary caregiver or other close contact of an individual within first 5 years of onset of a psychotic disorder who is poorly engaged or unengaged in psychiatric treatment

Exclusion criteria

* Not able to provide informed consent * Not proficient in English * History of developmental delay * Current acute mental health problem or distress

Design outcomes

Primary

MeasureTime frameDescription
Change in the Number of Mental Health Related Appointments Attended by the Individual With Psychosis (IP) in the Past 30 DaysChange from Baseline to 12 weeksThe participant will report the number of mental health related appointments attended by the IP during the past month via a structured survey.

Secondary

MeasureTime frameDescription
Change in Parents and Concerned Significant Others (PCSO) Expressed EmotionChange from Baseline to 12 weeksCaregiver 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).
Change in Parents and Concerned Significant Others (PCSO) DistressChange from Baseline to 12 weeksSymptoms 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.

Other

MeasureTime frameDescription
Change in Parents and Concerned Significant Others (PCSO) Acquisition of Motivational Interviewing SkillsChange from Baseline to 6 weeksPCSO 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.
Change in PCSO Beliefs and Self Confidence to ParentChange from Baseline to 6 weeksThis 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
53
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.
18
Total71

Baseline characteristics

CharacteristicTotalMotivational Interviewing for Loved Ones (MILO)Mental Health Services Consultation and Waitlist
Age, Continuous57.9 years
STANDARD_DEVIATION 8.9
57.1 years
STANDARD_DEVIATION 8.5
60.1 years
STANDARD_DEVIATION 9.9
Baseline mental health related appointments by the individual with psychosis (IP) in prior month1.73 number of appointments
STANDARD_DEVIATION 1.66
1.63 number of appointments
STANDARD_DEVIATION 1.62
2.00 number of appointments
STANDARD_DEVIATION 1.78
Baseline parents and concerned significant others (PCSO) distress19.48 score on a scale
STANDARD_DEVIATION 5.81
19.47 score on a scale
STANDARD_DEVIATION 5.75
19.50 score on a scale
STANDARD_DEVIATION 6.15
Baseline parents and concerned significant others (PCSO) expressed emotion54.76 score on a scale
STANDARD_DEVIATION 8.85
54.74 score on a scale
STANDARD_DEVIATION 8.42
54.83 score on a scale
STANDARD_DEVIATION 10.27
Baseline PCSO acquisition of motivational interviewing skills11.29 score on a scale
STANDARD_DEVIATION 4.72
10.98 score on a scale
STANDARD_DEVIATION 4.46
12.17 score on a scale
STANDARD_DEVIATION 5.44
Baseline PCSO beliefs and self confidence to parent57.89 score on a scale
STANDARD_DEVIATION 12.85
58.83 score on a scale
STANDARD_DEVIATION 11.99
55.21 score on a scale
STANDARD_DEVIATION 15.07
Race/Ethnicity, Customized
Asian
7 Participants4 Participants3 Participants
Race/Ethnicity, Customized
Black
4 Participants3 Participants1 Participants
Race/Ethnicity, Customized
Hispanic
2 Participants2 Participants0 Participants
Race/Ethnicity, Customized
Prefer not to state
3 Participants2 Participants1 Participants
Race/Ethnicity, Customized
White
55 Participants42 Participants13 Participants
Region of Enrollment
United States
71 Participants53 Participants18 Participants
Sex: Female, Male
Female
51 Participants39 Participants12 Participants
Sex: Female, Male
Male
20 Participants14 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 530 / 18
other
Total, other adverse events
0 / 530 / 18
serious
Total, serious adverse events
0 / 530 / 18

Outcome results

Primary

Change in the Number of Mental Health Related Appointments Attended by the Individual With Psychosis (IP) in the Past 30 Days

The participant will report the number of mental health related appointments attended by the IP during the past month via a structured survey.

Time frame: Change from Baseline to 12 weeks

Population: There was missing data for 11 of the MILO and 1 of the Waitlist groups

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing for Loved Ones (MILO)Change in the Number of Mental Health Related Appointments Attended by the Individual With Psychosis (IP) in the Past 30 Days0.29 number of appointmentsStandard Deviation 1.64
Mental Health Services Consultation and WaitlistChange in the Number of Mental Health Related Appointments Attended by the Individual With Psychosis (IP) in the Past 30 Days-1.06 number of appointmentsStandard Deviation 1.95
Secondary

Change in Parents and Concerned Significant Others (PCSO) Distress

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.

Time frame: Change from Baseline to 12 weeks

Population: There was missing data for 8 of the MILO and 1 of the Waitlist groups

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing for Loved Ones (MILO)Change in Parents and Concerned Significant Others (PCSO) Distress-3.91 score on a scaleStandard Deviation 5.86
Mental Health Services Consultation and WaitlistChange in Parents and Concerned Significant Others (PCSO) Distress-4.47 score on a scaleStandard Deviation 7.48
Secondary

Change in Parents and Concerned Significant Others (PCSO) Expressed Emotion

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).

Time frame: Change from Baseline to 12 weeks

Population: There was missing data for 8 of the MILO and 1 of the Waitlist groups

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing for Loved Ones (MILO)Change in Parents and Concerned Significant Others (PCSO) Expressed Emotion-7.82 score on a scaleStandard Deviation 10.46
Mental Health Services Consultation and WaitlistChange in Parents and Concerned Significant Others (PCSO) Expressed Emotion-7.0 score on a scaleStandard Deviation 11.24
Other Pre-specified

Change in Parents and Concerned Significant Others (PCSO) Acquisition of Motivational Interviewing Skills

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.

Time frame: Change from Baseline to 6 weeks

Population: There was missing data for 8 of the MILO and 4 of the Waitlist groups

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing for Loved Ones (MILO)Change in Parents and Concerned Significant Others (PCSO) Acquisition of Motivational Interviewing Skills5.09 score on a scaleStandard Deviation 3.67
Mental Health Services Consultation and WaitlistChange in Parents and Concerned Significant Others (PCSO) Acquisition of Motivational Interviewing Skills5.29 score on a scaleStandard Deviation 4.41
Other Pre-specified

Change in PCSO Beliefs and Self Confidence to Parent

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.

Time frame: Change from Baseline to 6 weeks

Population: There was missing data for 10 of the MILO and 1 of the Waitlist groups

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing for Loved Ones (MILO)Change in PCSO Beliefs and Self Confidence to Parent5.59 score on a scaleStandard Deviation 12.66
Mental Health Services Consultation and WaitlistChange in PCSO Beliefs and Self Confidence to Parent12.12 score on a scaleStandard Deviation 13.13

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026