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Articles   |    
Generalizability in the Family-to-Family Education Program Randomized Waitlist-Control Trial
Sue M. Marcus, Ph.D.; Deborah Medoff, Ph.D.; Li Juan Fang, M.S.; James Weaver, M.P.H.; Naihua Duan, Ph.D.; Alicia Lucksted, Ph.D.; Lisa B. Dixon, M.D., M.P.H.
Psychiatric Services 2013; doi: 10.1176/appi.ps.002912012
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Dr. Marcus and Dr. Duan are affiliated with the Departments of Psychiatry and Biostatistics in the Division of Biostatistics at New York State Psychiatric Institute (NYSPI), Columbia University, New York City. Dr. Dixon is affiliated with the Department of Psychiatry, Columbia University, and with NYSPI, New York City. Dr. Medoff, Ms. Fang, and Dr. Lucksted are with the Department of Psychiatry, University of Maryland School of Medicine, Baltimore. Mr. Weaver is with the Research Foundation for Mental Health, New York City. Send correspondence to Dr. Dixon, Department of Psychiatry, Columbia University/NYSPI, 1051 Riverside Dr., New York, NY 10032 (e-mail: dixonli@nyspi.columbia.edu).

Copyright © 2013 by the American Psychiatric Association

Abstract

Objective  Randomized controlled trials (RCTs) may have limited generalizability for the community when a high proportion of individuals refuse randomization or otherwise do not participate—a not uncommon phenomenon. A randomized waitlist-control trial of the Family-to-Family (FTF) education program, a 12-week course offered by the National Alliance on Mental Illness for family members of adults with mental illness, was previously reported. This study assessed whether the RCT-derived estimates of effectiveness of FTF were generalizable to individuals who participated in FTF but declined participation in the RCT.

Methods  Propensity score matching was used to create five quintiles, each containing scores for individuals in FTF or waitlist conditions and for decliners; scores were matched on multiple baseline characteristics (N=442) within each quintile. Effectiveness estimates, with standard errors, were derived for the decliner population on the basis of effectiveness estimates derived from participants in the RCT; estimates were weighted to the baseline distribution of quintiles for the decliners.

Results  For each outcome, estimates of the effect sizes observed in the RCT were very similar to the effect sizes observed for the decliner population; confidence intervals also had a high degree of overlap.

Conclusions  This study suggests that the benefits of FTF observed in the RCT are generalizable to the group of individuals who declined RCT participation, providing further evidence of FTF’s effectiveness. Propensity score matching was a useful statistical tool for addressing selection bias resulting from high rates of nonconsent in randomized waitlist-control trials.

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Figure 1 Percentage of participants reporting that a family member had a psychiatric hospitalization in the past 6 months, by propensity score quintilea

a Respondents received or were waitlisted to receive the 12-week Family-to-Family (FTF) psychoeducation program in a randomized controlled trial (RCT). Persons who declined random assignment (decliners) received FTF but did not participate in the RCT.

Figure 2 Knowledge scores at 3 months, by propensity score quintilea

a Respondents received or were waitlisted to receive the 12-week Family-to-Family (FTF) psychoeducation program in a randomized controlled trial (RCT). Persons who declined random assignment (decliners) received FTF but did not participate in the RCT.

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Table 1Baseline covariates of participants in a randomized controlled trial (RCT) of the National Alliance on Mental Illness (NAMI) Family-to-Family psychoeducation, by propensity score quintiles
Table Footer Note

a From the Family Experience Interview Schedule. Possible scores range from 0 to 4, with higher scores indicating more frequent assistance in daily life.

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b From the Family Assessment Device. Possible scores range from 6 to 24, with higher scores indicating worse problem solving.

Table Footer Note

c T scores range from 38 to 81, with higher scores indicating more anxiety symptoms.

Table Footer Note

d T scores range from 33 to 81, with higher scores indicating more global symptoms.

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e Family Empowerment Scale. Possible scores range from 1 to 5, with higher scores indicating more empowerment.

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f From the COPE. Possible scores range from 4 to 16, with higher scores indicating better coping.

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g As measured on the Center for Epidemiological Studies Depression Scale. Possible scores ranges from 0 to 42, with higher scores indicating more severe depression symptoms.

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h Family Member Questionnaire. Possible scores range from 1 to 4, with higher scores indicating less worry and fewer burdens.

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Table 2Three-month outcomes in a randomized controlled trial (RCT) of participants receiving or waiting to receive Family-to-Family (FTF) psychoeducation, by propensity score quintile
Table Footer Note

a From the Family Assessment Device. Possible scores range from 6 to 24, with higher scores indicating worse problem solving.

Table Footer Note

b From the Brief Symptom Inventory. Anxiety T scores range from 38 to 81, with higher scores indicating more anxiety symptoms.

Table Footer Note

c T scores range from 33 to 81, with higher scores indicating more global symptoms.

Table Footer Note

d From the Family Empowerment Scale. Possible scores range from 1 to 5, with higher scores indicating more empowerment.

Table Footer Note

e From the COPE. Possible scores range from 4 to 16, with higher scores indicating better coping.

Table Footer Note

f As measured on the Center for Epidemiological Studies Depression Scale. Possible scores ranges from 0 to 42, with higher scores indicating more severe depression symptoms.

Table Footer Note

g From the Family Member Questionnaire. Possible scores range from 1 to 4, with higher scores indicating less worry and fewer burdens.

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Table 3Effectiveness of Family-to-Family program versus waitlist and estimated generalizability for persons declining random assignment in the randomized controlled trial (RCT)
Table Footer Note

a Comparisons were as follows: RCT, estimate from the RCT, excluding decliners (3). For decliners, the estimate is of Family-to-Family recipients versus the waitlist effect for the decliner group.

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