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

• ClinicalTrials.gov Identifier: NCT04010747
• Recruitment Status: Completed
• First Posted: July 8, 2019
• Results First Posted: April 7, 2023
• Last Update Posted: April 7, 2023
• Sponsor: Boston Medical Center
• Collaborators: Beth Israel Deaconess Medical Center; National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Boston Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Psychotic Disorders; Psychosis; Psychotic Episode	Behavioral: Motivational Interviewing for Loved Ones (MILO); Behavioral: Mental Health Services Consultation and Waitlist	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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment

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")

• 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.
• Primary Purpose: Treatment
• Official Title: Pilot Study of Motivational Interviewing for Loved Ones
• Actual Study Start Date: March 1, 2020
• Actual Primary Completion Date: April 30, 2022
• Actual Study Completion Date: April 30, 2022

Arms and Interventions

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 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).	Behavioral: Motivational Interviewing for Loved Ones (MILO); 4 sessions of behavioral coaching in motivational interviewing communication techniques; Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in the Number of Mental Health Related Appointments Attended by the Individual With Psychosis (IP) in the Past 30 Days [ Time Frame: Change from Baseline to 12 weeks ]
   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 :

1. Change in Parents and Concerned Significant Others (PCSO) Expressed Emotion [ Time Frame: Change from Baseline to 12 weeks ]
   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).
2. Change in Parents and Concerned Significant Others (PCSO) Distress [ Time Frame: Change from Baseline to 12 weeks ]
   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.

Other Outcome Measures:

1. Change in Parents and Concerned Significant Others (PCSO) Acquisition of Motivational Interviewing Skills [ Time Frame: Change from Baseline to 6 weeks ]
   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.
2. Change in PCSO Beliefs and Self Confidence to Parent [ Time Frame: Change from Baseline to 6 weeks ]
   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.

Eligibility Criteria

• 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
• 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

Contacts and Locations

Locations

United States, Massachusetts

Boston Medical Center

Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston Medical Center

Beth Israel Deaconess Medical Center

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Emily R Kline, PhD; Boston Medical Center

  Study Documents (Full-Text)

Documents provided by Boston Medical Center:

Study Protocol and Statistical Analysis Plan  [PDF] March 3, 2021

Informed Consent Form  [PDF] May 14, 2021

More Information

Additional Information:

Website containing information for potential study participants (approved by BIDMC IRB) 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Boston Medical Center
• ClinicalTrials.gov Identifier: NCT04010747
• Other Study ID Numbers: H-41305; 5K23MH118373-04 ( U.S. NIH Grant/Contract ); 2019P-000473 ( Other Identifier: Beth Israel Deaconess Medical Center )
• First Posted: July 8, 2019
• Results First Posted: April 7, 2023
• Last Update Posted: April 7, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Medical Center:

Parents; Family Members; Partner, Domestic

Additional relevant MeSH terms:

Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders