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Trial registered on ANZCTR


Registration number
ACTRN12623000796684
Ethics application status
Approved
Date submitted
23/06/2023
Date registered
26/07/2023
Date last updated
8/09/2024
Date data sharing statement initially provided
26/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness, feasibility, and acceptability of an online Family Empowerment Program (FEP) for people negatively impacted by their relative's substance use and mental health conditions.
Scientific title
A randomized wait list control study of 6 sessions of Online Community Reinforcement and Family Training (CRAFT) on wellbeing of family members of people with substance dependence and mental illness
Secondary ID [1] 309962 0
None
Universal Trial Number (UTN)
U1111-1294-1918
Trial acronym
FEP Trial
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
psychological wellbeing 330442 0
stress 330443 0
depression 330444 0
anxiety 330445 0
substance dependence 330446 0
Condition category
Condition code
Mental Health 327294 327294 0 0
Addiction
Mental Health 327295 327295 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Community Reinforcement and Family Training (CRAFT) is an evidence-based counselling program based on cognitive behavioural therapy and motivational interviewing techniques that helps family members to improve their wellbeing, reduce substance use by their relative and support that relative to engage in treatment. In this trial we are delivering CRAFT online and calling it the Family Empowerment Program (FEP).
The randomized wait-list control trial will assess the effectiveness, feasibility and acceptability of online FEP with a parallel group, two-arm, superiority design with a 1:1 allocation ratio comparing online FEP with a wait-list control. Given the lack of information regarding substance use interventions for families of people with a mental health condition qualitative methods will explore the experiences of study participants as well as clinicians and referral agents.
Clinicians delivering FEP will attend 2 days face to face training on the program procedures delivered by an accredited trainer. Training will be held one month before recruitment into the trial commences. The training manual is attached in project materials. They will be subsequently accredited by the same trainer via submitting recordings of FEP counselling sessions that will be evaluated against the standard CRAFT procedures. Clinicians must be registered or provisional psychologists, social workers, occupational therapists or mental health nurses with at least 2 years experience in counselling.
Clinicians delivering FEP will be trained and accredited using the standard procedures and assessments established by Robert J. Meyers (therapist certification - Robert J. Meyers, Ph.D. - Workshops (robertjmeyersphd.com) .
The study will be conducted in Australia. The FEP program will be delivered online to people meeting the inclusion criteria who live in a rural area (Modified Monash Model 2-7) of NSW, Victoria and QLD. The program will be delivered from the worksites of the clinicians trained and accredited and employed to deliver it using Zoom as the delivery platform.
The Family Empowerment Program Online comprises 6 sessions of 60 minutes each delivered to individuals. A further two sessions will be available if participants wish to consolidate any skills or revisit a topic. The key focus of sessions is on learning new skills and how to use them, so that participants can change the way they behave and interact with their loved ones. Skills that participants will learn include effective communication and problem-solving skills; how to be more assertive while not provoking conflict and how to improve their own sense of well-being.

FEP Program schedule
Six sessions make up the FEP program. The order of sessions can be moved around if required.
Session 1, building motivation and self-care, includes introducing the family member to FEP rationale, psychoeducation, and establishing self-care goals.
Session 2, communication, includes general positive communication strategies and role plays.
Session 3, functional analysis of client substance use, includes identifying the client's typical substance use behavior, internal and external triggers, short-term positive consequences, and long-term negative consequences.
Session 4, positive reinforcement, includes reinforcement of recovery-oriented non-substance use behaviors.
Session 5 problem-solving and natural consequences, includes practice of problem-solving procedures, provides guidelines for allowing for natural consequences of substance use to occur.
Session 6, discussing treatment engagement, includes “windows of opportunity” and “motivational hooks” for engaging a loved one in treatment. Program review and next steps, includes a summary and review of program topics, planning to maintain progress and skill work, and providing additional resources or 2 extra sessions if required by the participant.

Milestone conversations (weeks 2,3 & 6)
Designed to reduce the family members assumptions about what is important and rewarding about substance use to their relative and to ascertain the relative’s views on substance treatment.
(1) What is most important to their relative currently? What are they looking forward to? What do they enjoy doing?
(2) What are their relative's substance use patterns and what benefits do they get?
(3) How does their relative feel about substance treatment? What is their experience with it?
Milestone conversations are planned during the session in week 2, 3 or 6 and intended to be undertaken by the study participant with their relative before the next session. Milestone conversations will take 15 minutes to plan.
Intervention code [1] 326378 0
Behaviour
Comparator / control treatment
A wait list control group will be provided reading material. Participants randomized to the wait list will receive a copy of the parents or partners Invitation to Change 20-minute guide while waiting to receive FEP. The time on the wait list will be 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 335168 0
Difference between the two treatment arms in the proportion of participants classed as having improved anxiety, depression and/or stress.
This outcome is assessed via an online survey that includes - Depression, Anxiety, and Stress Scale (DASS-21).
Timepoint [1] 335168 0
18 weeks post baseline
Primary outcome [2] 335288 0
Difference between the two treatment arms in the proportion of participants classed as having improved satisfaction with their life circumstances.
This outcome is assessed via an online survey that includes - Satisfaction with Life Scale (SWLS).
Timepoint [2] 335288 0
18 weeks post baseline
Primary outcome [3] 335361 0
Difference between the two treatment arms in the proportion of participants classed as having improved self-perceived success in relationships, self-esteem, purpose, and optimism.
This outcome is assessed via an online survey that includes - The Flourishing Scale (FS).
Timepoint [3] 335361 0
18 weeks post-baseline
Secondary outcome [1] 423373 0
A change in the the person with substance dependence attendance at substance dependence services in the period during which FEP was delivered as reported by the family member. This outcome is assessed via interview with study participants. A semi-structured interview will be conducted by a member of the research team. Interviews will last approximately 40-60 minutes and will be audio-recorded and transcribed.
Timepoint [1] 423373 0
18 week post baseline interview.
Secondary outcome [2] 423374 0
Change in substance use in the person with substance dependence as reported by a participating family member during interview. A semi-structured interview will be conducted by a member of the research team. Interviews will last approximately 40-60 minutes and will be audio-recorded and transcribed.
Timepoint [2] 423374 0
18 weeks post baseline interview
Secondary outcome [3] 423375 0
to identify the factors associated with implementation as perceived by participants, This outcome will be assessed by the FEP session record question on ease of use and post program interview. A semi-structured interview will be conducted by a member of the research team. Interviews will last approximately 40-60 minutes and will be audio-recorded and transcribed.
Timepoint [3] 423375 0
Session rating at the end of each session; 18 weeks post baseline interview
Secondary outcome [4] 423782 0
to identify the factors associated with implementation as perceived by clinicians via interview and usage rating profile measure (URP-Intervention). A semi-structured interview will be conducted by a member of the research team. Interviews will last approximately 40-60 minutes and will be audio-recorded and transcribed.
Timepoint [4] 423782 0
Study end
Secondary outcome [5] 423783 0
to identify the factors associated with implementation as perceived by referral agents. Assessed via semi-structured interview conducted by a member of the research team. Interviews will last approximately 40-60 minutes and will be audio-recorded and transcribed.
Timepoint [5] 423783 0
Study end
Secondary outcome [6] 424096 0
Feasibility - extent of exposure to FEP by participants (number & length of sessions attended as logged by treating clinician). This is an additional primary outcome.
Timepoint [6] 424096 0
End of FEP program for each participant
Secondary outcome [7] 424104 0
Difference between the two treatment arms in the proportion of participants classed as having improved self-perceived ability to cope with personal problems and stressful situations.
This outcome is assessed via an online survey that includes - Brief - Coping Orientation to Problems Experienced Inventory (Brief-COPE). This is an additional primary outcome.
Timepoint [7] 424104 0
18 weeks post baseline

Eligibility
Key inclusion criteria
1. Family member/s of someone with substance dependence and a mental illness
2. speaks English
3. over 18 years of age
4. is able and willing to attend FEP sessions
5. Is able to provide informed consent
6. having at least one contact/day on four days over the past month (in-person or electronic) with the Identified Relative (IR)
7. access to a computer with internet or mobile phone with video conferencing capabilities
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Domestic and family violence from the person with substance dependence to the family member
2. current participation in family support/therapy programs
3. major uncontrolled psychiatric illness of the family member

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation procedure will be conducted using Stata Version 14 SE by a researcher (KA at RHRI) independent from all other aspects of project implementation, including FEP facilitation and data collection
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be conducted for primary outcomes, and intention-to-treat, multilevel mixed effects analysis for repeated measures will be performed for primary and secondary outcomes.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
1/11/2023
Date of last participant enrolment
Anticipated
30/09/2024
Actual
3/09/2024
Date of last data collection
Anticipated
3/02/2025
Actual
Sample size
Target
120
Accrual to date
Final
127
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 314135 0
Government body
Name [1] 314135 0
Department of Health and Aged Care (DoHAC), Australian Commonwealth Government.
Country [1] 314135 0
Australia
Primary sponsor type
University
Name
Rural Health Research Institute, Charles Sturt University
Address
Building 1008, Leeds Pd,, Orange NSW 2800
Country
Australia
Secondary sponsor category [1] 316058 0
None
Name [1] 316058 0
Address [1] 316058 0
Country [1] 316058 0
Other collaborator category [1] 282721 0
University
Name [1] 282721 0
National Drug and Alcohol Research Centre, UNSW
Address [1] 282721 0
University of New South Wales
Kensington, NSW, 2033
Country [1] 282721 0
Australia
Other collaborator category [2] 282722 0
University
Name [2] 282722 0
Poche Centre, University of QLD
Address [2] 282722 0
74 High St, Toowong QLD 4066
Country [2] 282722 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313271 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [1] 313271 0
Ethics committee country [1] 313271 0
Australia
Date submitted for ethics approval [1] 313271 0
12/07/2023
Approval date [1] 313271 0
28/08/2023
Ethics approval number [1] 313271 0
HREC Proposal Approval - Aspro Julaine Maree Allan Protocol: H23769

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127554 0
A/Prof Julaine Allan
Address 127554 0
Rural Health Research Institute, Charles Sturt University, Building 1008, Leeds Pd, Orange, NSW, 2800
Country 127554 0
Australia
Phone 127554 0
+61 2 6365 7119
Fax 127554 0
Email 127554 0
juallan@csu.edu.au
Contact person for public queries
Name 127555 0
Julaine Allan
Address 127555 0
Rural Health Research Institute, Charles Sturt University, Building 1008, Leeds Pd, Orange, NSW, 2800
Country 127555 0
Australia
Phone 127555 0
+61 2 6365 7119
Fax 127555 0
Email 127555 0
juallan@csu.edu.au
Contact person for scientific queries
Name 127556 0
Julaine Allan
Address 127556 0
Rural Health Research Institute, Charles Sturt University, Building 1008, Leeds Pd, Orange, NSW, 2800
Country 127556 0
Australia
Phone 127556 0
+61 2 6365 7119
Fax 127556 0
Email 127556 0
juallan@csu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
deidentified outcome measures with analysis
When will data be available (start and end dates)?
1 July 2025 - 31 December, 2025
Available to whom?
in a public repository available to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
meta - analyses
How or where can data be obtained?
Subject to approval from principal investigator juallan@csu.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19522Study protocol  juallan@csu.edu.au 386124-(Uploaded-03-09-2024-11-38-58)-Family Empowerment Project_StudyProtocol_V.4_R3.docx
19616OtherAllan, J., Snowdon, N. (2023). FAMILY EMPOWERMENT PROGRAM BRIEF FACILITATOR GUIDE.   Family Empowerment Program training manual 386124-(Uploaded-18-07-2023-15-32-12)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for the family empowerment program: a randomized waitlist-controlled trial to evaluate the effectiveness of online Community Reinforcement and Family Training (CRAFT) on the wellbeing of family members with a relative experiencing substance dependence and mental illness.2024https://dx.doi.org/10.1186/s12888-023-05487-0
N.B. These documents automatically identified may not have been verified by the study sponsor.