Pilot Study of Motivational Interviewing for Loved Ones

NCT04010747 | Completed Results

• 3 other identifiers: H-413055K23MH118373-042019P-000473
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders; Psychosis; Psychotic Episode

Keywords

Parents; Family Members; Partner, Domestic

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline to 12 weeks

Secondary Outcomes (2)

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

  Change from Baseline to 12 weeks

• Change in Parents and Concerned Significant Others (PCSO) Distress

  Change from Baseline to 12 weeks

Other Outcomes (2)

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

  Change from Baseline to 6 weeks

• Change in PCSO Beliefs and Self Confidence to Parent

  Change from Baseline to 6 weeks

Study Arms (2)

Motivational Interviewing for Loved Ones (MILO)

EXPERIMENTAL

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)

Mental Health Services Consultation and Waitlist

ACTIVE COMPARATOR

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); Behavioral: Mental Health Services Consultation and Waitlist

Interventions

Motivational Interviewing for Loved Ones (MILO) BEHAVIORAL

4 sessions of behavioral coaching in motivational interviewing communication techniques

Mental Health Services Consultation and Waitlist; Motivational Interviewing for Loved Ones (MILO)

Mental Health Services Consultation and Waitlist BEHAVIORAL

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.

Mental Health Services Consultation and Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead
• Beth Israel Deaconess Medical Center: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 33868061 DERIVED

Related Links

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

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Motivational Interviewing; Waiting Lists

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Appointments and Schedules; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Emily R Kline, PhD
• Organization: Boston Medical Center & BU Chobanian & Avedisian School of Medicine

emily.kline@bmc.org

401-206-0586

Study Officials

• Emily R Kline, PhD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Prior to the crossover the study will be open label. After the crossover, the outcome assessor will be blinded to study condition.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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")

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 8, 2019
• Study Start: March 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)