NCT04010747: MILO-Pilot

Pilot Study of Motivational Interviewing for Loved Ones

Completed NA Results posted Last updated 7 April 2023

What this trial tests

NA trial testing Motivational Interviewing for Loved Ones (MILO) in Psychotic Disorders in 71 participants. Completed in 30 April 2022.

Timeline

1 March 2020

Primary endpoint
30 April 2022

30 April 2022

Quick facts

Lead sponsor	Boston Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	71
Start date	1 March 2020
Primary completion	30 April 2022
Estimated completion	30 April 2022
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Psychotic Disorders — all drugs for Psychotic Disorders →
• Psychosis — all drugs for Psychosis →
• Psychotic Episode — all drugs for Psychotic Episode →

Sponsor

Boston Medical Center

Who can join

18 and older, any sex, with Psychotic Disorders or Psychosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Motivational Interviewing for Loved Ones (MILO)	0.29	± 1.64
Mental Health Services Consultation and Waitlist	-1.06	± 1.95

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

Group	Value	95% CI
Motivational Interviewing for Loved Ones (MILO)	-7.82	± 10.46
Mental Health Services Consultation and Waitlist	-7.0	± 11.24

Change in Parents and Concerned Significant Others (PCSO) Distress Secondary · 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.

Group	Value	95% CI
Motivational Interviewing for Loved Ones (MILO)	-3.91	± 5.86
Mental Health Services Consultation and Waitlist	-4.47	± 7.48

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

Group	Value	95% CI
Motivational Interviewing for Loved Ones (MILO)	5.09	± 3.67
Mental Health Services Consultation and Waitlist	5.29	± 4.41

Change in PCSO Beliefs and Self Confidence to Parent Secondary · 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.

Group	Value	95% CI
Motivational Interviewing for Loved Ones (MILO)	5.59	± 12.66
Mental Health Services Consultation and Waitlist	12.12	± 13.13

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Motivational Interviewing for Loved Ones in Early Psychosis: Development and Pilot Feasibility Trial of a Brief Psychoeducational Intervention for Caregivers.
   Kline ER, Thibeau H, Sanders AS, English K, et al · · 2021 · cited 12× · PMID 33868061 · DOI 10.3389/fpsyt.2021.659568
2. Motivational interviewing for loved ones: Randomized controlled trial of brief training for first episode psychosis caregivers.
   Kline ER, Thibeau H, Davis BJ, Fenley A, et al · · 2022 · cited 10× · PMID 36279833 · DOI 10.1016/j.schres.2022.10.005