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					Be Careful What You Wish For!
  The Saga of our FtF Study


     Lisa Dixon, M.D., M.P.H.
      Professor of Psychiatry
  University of Maryland School of
              Medicine
  VA Capitol Health Care Network
              MIRECC
                Outline
 The story of what it takes to secure a
  grant from NIMH
 Study design and goals
 Whether positive findings in this study
  (the 3rd) will give us the evidence base
  for FtF that we need so much
 When you expect interpretable data to
  come in (i.e., how long must we wait).
                  Outline
   The story of what it takes to secure a
    grant from NIMH


3 Studies and a Great Team
            Study 1: A State Survey of Services
            Provided to Families of Adults with
                   Severe Mental Illness

     Five question survey distributed to State
      Mental Health Authorities
     88% Response Rate
     Collaboration with the National Association of
      State Mental Health Program Directors

Dixon L, Goldman HH, Hirad A: State policy and funding of services to families of adults with serious and
persistent mental illness, Psychiatric Services 1999;50:551-552.
Does Your State Fund or Sponsor
Any Family Support Intervention?

               None
               20%




Other Family
    12%               Family to
                       Family
Fam Psychoed            61%
   (EBP)
    7%
Study 2: Pilot--Uncontrolled
 pre-post study of FtF with
 six-month follow-up
Study 3: Prospective waiting
 list control study of FtF
  Results: Affective Response Module of
      Family Experience Interview
 3

2.8

2.6
                                                   Worry (Study 2)
                                                   Worry (Study 3)
2.4

2.2

 2
      -3 (WL)    0 (BL)   3 (Post-   9 (6 months
                          FFEP)      post-FFEP)

                Less Worry over time       6 Mo=Post FFEP>BL=WL
  Results: Affective Response Module of
      Family Experience Interview

 3

2.5
                                                Displeasure (Study 2)
 2
                                                Displeasure (Study 3)
1.5

 1
      -3 (WL)   0 (BL)   3 (Post-    9 (6
                         FFEP)      months
                                     post-
                                    FFEP)
        Less Displeasure over time
                                             6 Mo=Post FFEP>BL=WL
      Results: Family Empowerment
            Scale: Community
  4
3.8
3.6
3.4                                             Community (Study 2)
3.2
  3
2.8                                             Community (Study 3)
2.6
2.4
2.2
  2
      -3 (WL)   0 (BL)   3 (Post-  9 (6mos
                         FFEP)      Post-
                                   FFEP)
 Greater Experience of Empowerment Within the Community Over Time
                6 Mo=Post FFEP>BL=WL
       Results: Family Empowerment
                  Scale:
                  Family
  4
3.8
3.6
3.4
3.2
                                                       Family (Study 2)
  3
2.8                                                    Family (Study 3)
2.6
2.4
2.2
  2
        -3 (WL)    0 (BL)     3 (Post-   9 (6mos
                              FFEP)       Post-
                                         FFEP)
      Greater Experience of Empowerment Within the Family Over Time
                    6 Mo=Post FFEP>BL=WL
       Results: Family Empowerment
                  Scale:
              Service System
  4
3.8
3.6
3.4
                                                        Service System
3.2
                                                        (Study 2)
  3
2.8                                                     Service System
                                                        (Study 3)
2.6
2.4
2.2
  2
      -3 (WL)      0 (BL)     3 (Post-     9 (6mos
                              FFEP)      Post-FFEP)
Greater Experience of Empowerment Within the Service System Over Time
                6 Mo=Post FFEP>BL=WL
      Results: FMQ and FTF Scales
                (Study 3)
3.5

3.3
                                                   Problem Solving
3.1
                                                   Understanding MHS
2.9                                                Knowledge of SMI
                                                   Self Care
2.7

2.5
      -3 (WL)    0 (BL)   3 (Post-   9 (6mos
                          FFEP)       Post-
                                     FFEP)
Greater Experience of Empowerment Within the Community Over Time
                6 Mo=Post FFEP>BL=WL
Results: Family to Family Questions
   Same change pattern observed for:
    – I understand the causes of mental illness
    – I understand the medications used to treatment
        mental illness
    –   I understand the symptoms of mental illness
    –   I have realistic expectations
    –   I know who to turn to for help when feeling upset
    –   I know how to advocate for better treatment
    –   I know how to communicate my concerns
Results: Family to Family Questions
   Same change pattern observed for:
    – I worry about what the future will bring
    – Trying to deal with my relative makes me feel
        helpless
    –   I can set firm limits with my relative
    –   I know my relative is doing the best he/she can
    –   Being in a peer family group makes me feel safer
    –   I can challenge authority figures when I need to
    –   I can identify the support that I need
 CES-D Depression Scale

14
13
12                                      Study 3
11
10
9
8
7
6
     Waitlist     Pre    Post    Six
                                Month
                6-mo<WL, Pre
                             Timeline
   1998: First Pilot (Study 2) of Ftf Conducted
   1999: Study of State Funding Published (Study 1)
   2001 Study 2 Published
   11/1/00-10/31/02: RWJ Grant for Study 3
    conducted
   2/1/2004: NIMH Grant Submitted
   6/2004: NIMH Grant Reviewed
   2004: Study 3 Published
   11/1/04: Revised NIMH Grant Submitted
   2/2005: Revised NIMH Grant Reviewed
   4-5/2005: Additional Comments provided to
    NIMH from second review
   9/23/05-7/31/09: Grant Awarded
   3/13/06: Enrolled First Participant
                   The Team
   Lisa, Alicia, Bette, Karen,
    Aaron, Deb, Rebecca, LiJuan,
    Joyce, Howard, Tony, Ann,
    Kate, Christa, Dagmar, Esther,
    Jim, Carol, Barbara, Susan,
    Linda, Jack, Shari, Jim, Aisha,
    Colleen, Clay, Terrence,
    Barbara, Jackie, Jeanette, Allen,
    Sue, Charisse, Natalie and more
                Outline
 The story of what it takes to secure a
  grant from NIMH
 Study design and goals
 Whether positive findings in this study
  (the 3rd) will give us the evidence base
  for FtF that we need so much
 When you expect interpretable data to
  come in (i.e., how long must we wait).
     Study Design and Goals
 Specific Aim 1: To assess whether FTF
  involvement results in study participants’
  reporting increased constructive coping
  activities, both problem-focused and
  emotionally-focused.
 Specific Aim 2: To assess whether FTF
  participation results in participants’ reporting
  improved adjustment and well-being.
    Study Design and Goals
Secondary Aims
 To assess whether FTF participants retain
  program benefits over time (6 months).
 To assess whether FTF participation results
  in changed appraisal of the stressor of having
  a relative with a SMI.
 To assess whether FTF participation results
  in improved family functioning.
      Study Design and Goals
   To describe the demographic,
    diagnostic, and service utilization
    characteristics of consumer relatives of
    all participants, and to assess whether
    consumer relatives of FTF participants
    show improved clinical and recovery-
    oriented outcomes compared to
    consumer relatives of control
    participants.
   Study Design and Goals

                 Randomized               Completes                  9 mo. Follow-Up
                   to FTF                   FTF                        Assessments
  Consenting                                                         (6 mo. post-FTF)
 FTF-eligible                  3 months                   6 months
family member

                                              After
                 Randomized               Interview 2,
                  to Control              participation
                                              ends


                 Baseline                       3 month
                Assessments                    Assessments
    Study Design and Goals
 We need to recruit approximately 360
  participants with the goal of evaluating 300
  persons at the end of the FtF class period.
 We are conducting the study with four
  wonderful and incredibly collaborative
  Maryland affiliates: Baltimore City/County,
  Howard, Montgomery and Frederick Counties
  of Maryland
                Outline
 The story of what it takes to secure a
  grant from NIMH
 Study design and goals
 Whether positive findings in this study
  (the 3rd) will give us the evidence base
  for FtF that we need so much
 When you expect interpretable data to
  come in (i.e., how long must we wait).
                Outline
 The story of what it takes to secure a
  grant from NIMH
 Study design and goals
 Whether positive findings in this study
  (the 3rd) will give us the evidence base
  for FtF that we need so much
 When you expect interpretable data to
  come in (i.e., how long must we wait).
  It Depends




On Study Recruitment!!
Questions?

Comments?


 Thanks!

				
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