Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010747
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Emily Kline, Beth Israel Deaconess Medical Center

Brief Summary:
The proposed trial is entitled "Pilot study of Motivational Interviewing for Loved Ones (MILO)." The study population is 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. I hypothesize that the intervention will be superior to control condition for both enhancing IP engagement with mental health services and reducing PCSO distress.

Condition or disease Intervention/treatment Phase
Parents Psychosis Psychotic Disorders Psychotic Episode Family Members Partner, Domestic Behavioral: Motivational Interviewing for Loved Ones (MILO) Behavioral: Mental Health Services Consultation Not Applicable

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.

This study is entitled Motivational Interviewing for Loved Ones (MILO). The study population is parents and concerned significant others (PCSO) of individuals experiencing psychosis (IP) who are not currently engaged with treatment, ambivalently engaged, or at high risk for drop-out. 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 = 30). During phase 2, participants will be randomly assigned to either receive MILO (50%) or TAU (50%). The trial will involve a total of 60 participants. All study activities will take place at the primary site, Beth Israel Deaconess Medical Center.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The first 30 participants to enroll in this study will automatically receive in a training intervention, called "Motivational Interviewing for Loved Ones" (MILO) ("Phase 1").

After that, participants will be randomly assigned to the intervention (MILO) or to a control condition involving a 30-45 minute mental health services consultation ("Phase 2")

Masking: Single (Outcomes Assessor)
Masking Description: Phase 1 will be open label. In Phase 2, the person assessing outcomes will be blinded to study condition.
Primary Purpose: Treatment
Official Title: Pilot Study of Motivational Interviewing for Loved Ones
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Motivational Interviewing for Loved Ones (MILO)
4 sessions of behavioral coaching in motivational interviewing communication techniques

Active Comparator: Mental Health Services Consultation
This consultation will consist of a 30-45 minute appointment in which participants can meet with a clinician knowledgeable about psychosis treatment resources in their area. He/she can recommend specific programs, educational websites, and/or support groups that might be relevant for the participant's family. Participants will also be offered direct assistance with a referral to mental health treatment for their loved one.
Behavioral: Mental Health Services Consultation
1 session of individualized consultation on relevant mental health services for the IP and participating PCSO, with assistance offered in making a specific referral.




Primary Outcome Measures :
  1. Mental health service utilization by the individual with psychosis ("IP") [ Time Frame: Change from Baseline to 12 weeks ]
    The participant ("PCSO") will report mental health service utilization by the IP during the past month via a structured survey.


Secondary Outcome Measures :
  1. PCSO Burden [ Time Frame: Change from Baseline to 12 weeks ]
    Emotional and financial burden of mental illness on the family; measured via the Burden Assessment Scale. The scale contains 19 items and has a total range of 0-57. Higher scores represent more burden.

  2. PCSO Distress [ Time Frame: Change from Baseline to 12 weeks ]
    Symptoms of depression, anxiety, and behavioral disorders experienced by the PCSO; measured via a modified version of Global Assessment of Individual Needs Short Screener (GAIN-SS). The scale has been modified to remove question about suicidal ideation and intent. The modified scale has 19 items and total score range of 19-76 with higher scores representing more distress or psychopathology.


Other Outcome Measures:
  1. PCSO acquisition of motivational interviewing skills [ Time Frame: Change from Baseline to 6 weeks ]
    PCSO will attempt to demonstrate motivational interviewing skills in a recorded role play; role play will be scored using the Behavior Count component of the Motivational Interviewing Treatment Integrity Scale. Higher frequency counts of the following behaviors represent increased proficiency in motivational interviewing skills: giving information, persuading with permission, questioning, reflecting, affirming, seeking collaboration, and emphasizing autonomy.

  2. PCSO self-efficacy beliefs [ Time Frame: Change from Baseline to 6 weeks ]
    PCSO's belief that he/she can solve problems and accomplish goals; measured via the General Self-Efficacy Scale. This scale has 10 items and total score range of 10-40 with higher scores representing more self-efficacy beliefs.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • 20 or more hours of weekly contact with an individual with an adolescent or young adult (age 15-35) with psychosis who is poorly or not at all engaged with mental health treatment

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010747


Contacts
Layout table for location contacts
Contact: Emily Kline, PhD 617-754-1262 ekline@bidmc.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Emily Kline, PhD    617-754-1262    ekline@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Emily Kline, PhD Beth Israel Deaconess Medical Center
Additional Information:
Layout table for additonal information
Responsible Party: Emily Kline, Instructor in Psychology in the Department of Psychiatry, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04010747    
Other Study ID Numbers: 2019P-000473
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders