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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]

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

stress

depression

anxiety

substance dependence

Condition category

Condition code

Mental Health

Addiction

Mental Health

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]

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]

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]

18 weeks post baseline

Primary outcome [2]

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]

18 weeks post baseline

Primary outcome [3]

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]

18 weeks post-baseline

Secondary outcome [1]

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]

18 week post baseline interview.

Secondary outcome [2]

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]

18 weeks post baseline interview

Secondary outcome [3]

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]

Session rating at the end of each session; 18 weeks post baseline interview

Secondary outcome [4]

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]

Study end

Secondary outcome [5]

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]

Study end

Secondary outcome [6]

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]

End of FEP program for each participant

Secondary outcome [7]

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]

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?

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]

Government body

Name [1]

Department of Health and Aged Care (DoHAC), Australian Commonwealth Government.

Address [1]

Sirius Building, Furzer St, Woden Town Centre ACT 2606

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

National Drug and Alcohol Research Centre, UNSW

Address [1]

University of New South Wales
Kensington, NSW, 2033

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Poche Centre, University of QLD

Address [2]

74 High St, Toowong QLD 4066

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Charles Sturt University Human Research Ethics Committee

Ethics committee address [1]

Leeds Parade, Orange, NSW, 2800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/07/2023

Approval date [1]

28/08/2023

Ethics approval number [1]

HREC Proposal Approval - Aspro Julaine Maree Allan Protocol: H23769

Summary

Brief summary

Research question: Is it effective, feasible, and acceptable to deliver FEP (CRAFT) online?
The primary aims of this study are to a.) evaluate the effectiveness of an online delivery of FEP to family members with a loved one experiencing substance problems and mental health conditions; and b.) Feasibility - extent of exposure to FEP by participants (number& length of sessions attended). The secondary aims are to identify the factors associated with successful implementation as perceived by a.) participants, b.) clinicians & c.) referral agents; and 2. whether the person with substance dependence a.) engaged with health or substance dependence services in the period during which FEP was delivered and b.) reduced their substance use as reported by a participating family member.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Julaine Allan

Address

Rural Health Research Institute, Charles Sturt University, Building 1008, Leeds Pd, Orange, NSW, 2800

Country

Australia

Phone

+61 2 6365 7119

Fax

[email protected]

Contact person for public queries

Name

Julaine Allan

Address

Rural Health Research Institute, Charles Sturt University, Building 1008, Leeds Pd, Orange, NSW, 2800

Country

Australia

Phone

+61 2 6365 7119

Fax

[email protected]

Contact person for scientific queries

Name

Julaine Allan

Address

Rural Health Research Institute, Charles Sturt University, Building 1008, Leeds Pd, Orange, NSW, 2800

Country

Australia

Phone

+61 2 6365 7119

Fax

[email protected]

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 [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
19522	Study protocol			[email protected]		386124-(Uploaded-03-09-2024-11-38-58)-Family Empowerment Project_StudyProtocol_V.4_R3.docx
19616	Other	Allan, 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

Source	Title	Year of Publication	DOI
Embase	Study 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.	2024	https://dx.doi.org/10.1186/s12888-023-05487-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically