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Pilot Study of Motivational Interviewing for Loved Ones (MILO-Pilot)

Primary Purpose

Psychotic Disorders, Psychosis, Psychotic Episode

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing for Loved Ones (MILO)
Mental Health Services Consultation and Waitlist
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Parents, Family Members, Partner, Domestic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational Interviewing for Loved Ones (MILO)

Mental Health Services Consultation and Waitlist

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
July 2, 2019
Last Updated
April 5, 2023
Sponsor
Boston Medical Center
Collaborators
Beth Israel Deaconess Medical Center, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04010747
Brief Title
Pilot Study of Motivational Interviewing for Loved Ones
Acronym
MILO-Pilot
Official Title
Pilot Study of Motivational Interviewing for Loved Ones
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
Beth Israel Deaconess Medical Center, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Psychosis, Psychotic Episode
Keywords
Parents, Family Members, Partner, Domestic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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")
Masking
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.
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing for Loved Ones (MILO)
Arm Type
Experimental
Arm Description
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.
Arm Title
Mental Health Services Consultation and Waitlist
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing for Loved Ones (MILO)
Intervention Description
4 sessions of behavioral coaching in motivational interviewing communication techniques
Intervention Type
Behavioral
Intervention Name(s)
Mental Health Services Consultation and Waitlist
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Number of Mental Health Related Appointments Attended by the Individual With Psychosis (IP) in the Past 30 Days
Description
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
Secondary Outcome Measure Information:
Title
Change in Parents and Concerned Significant Others (PCSO) Expressed Emotion
Description
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
Title
Change in Parents and Concerned Significant Others (PCSO) Distress
Description
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
Other Pre-specified Outcome Measures:
Title
Change in Parents and Concerned Significant Others (PCSO) Acquisition of Motivational Interviewing Skills
Description
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
Title
Change in PCSO Beliefs and Self Confidence to Parent
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily R Kline, PhD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33868061
Citation
Kline ER, Thibeau H, Sanders AS, English K, Davis BJ, Fenley AR, Keshavan MS. Motivational Interviewing for Loved Ones in Early Psychosis: Development and Pilot Feasibility Trial of a Brief Psychoeducational Intervention for Caregivers. Front Psychiatry. 2021 Apr 1;12:659568. doi: 10.3389/fpsyt.2021.659568. eCollection 2021.
Results Reference
derived
Links:
URL
http://milostudy.com
Description
Website containing information for potential study participants (approved by BIDMC IRB)

Learn more about this trial

Pilot Study of Motivational Interviewing for Loved Ones

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