Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ANZCTR |
Last refreshed on:
|
20 March 2023 |
Main ID: |
ACTRN12617000942358 |
Date of registration:
|
30/06/2017 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Altitudes East-West: Effectiveness of a Moderated Online Social Therapy program for First Episode Psychosis carers
|
Scientific title:
|
A randomised controlled trial of Moderated Online Social Therapy for carers of early psychosis clients in real world settings |
Date of first enrolment:
|
16/10/2018 |
Target sample size:
|
160 |
Recruitment status: |
Completed |
URL:
|
https://anzctr.org.au/ACTRN12617000942358.aspx |
Study type:
|
Interventional |
Study design:
|
Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;
|
Phase:
|
Not Applicable
|
|
Countries of recruitment
|
Australia
| | | | | | | |
Contacts
|
Name:
|
Prof John Gleeson
|
Address:
|
Australian Catholic University
115 Victoria Parade
Fitzroy, VIC, Australia 3065
Australia |
Telephone:
|
+61 3 99533108 |
Email:
|
john.gleeson@acu.edu.au |
Affiliation:
|
|
|
Name:
|
Prof John Gleeson
|
Address:
|
School of Psychology, 115 Victoria Parade, Australian Catholic University, Fitzroy, VIC 3065
Australia |
Telephone:
|
+61 3 9953 3108 |
Email:
|
john.gleeson@acu.edu.au |
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: Carers (parent, guardian, grandparent, spouse, sibling) of a young person who is currently receiving treatment at a participating early psychosis service. For the current trial, eligibility criteria will be intentionally inclusive, to reflect the real-world nature of the settings in which the trial will be conducted. The inclusion criteria for the young person engaged in the early psychosis service are as follows: i) aged 12 – 40 years, ii) present with symptoms or a diagnosis of a first episode of psychosis.
More than one family member will be eligible to participate from each family.
Exclusion criteria: Carers who do not have sufficient English to be able to provide informed consent, complete all assessment measures, and actively engage in the Altitudes application will be excluded from the trial.
Carers who are currently engaged in legal action against their relative are also ineligible.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
|
Health Condition(s) or Problem(s) studied
|
Perceived stress;Objective Stress;Depression;Substance use; Perceived stress Objective Stress Depression Substance use
|
Mental Health - Depression
|
Mental Health - Other mental health disorders
|
Intervention(s)
|
Altitudes is a world-first online application, designed and built utilising our Moderated Online Social Therapy (MOST) software framework, which integrates three major functions within one web-based application. These include: (i) online psychoeducation (divided into specific thematic pathways which are further separated into individual “steps”); (ii) expert moderated social networking (via a “cafe menu”); and (iii) peer moderation. Each user can log on at their convenience, 24 hours per day. Participants will have access to the intervention for 6 months.
The features of the online psychoeducation: New users are given an introductory welcome to Altitudes which highlights ways to optimise their use of the system and how to access system help. Uses are invited to complete, at their own convenience, a series of “pathways” organised into distinct themes including self-care, understanding psychosis, early warning signs and prevention of relapse, understanding their personal strengths as a carer, managing behavioural problems in their relative, and communicating with their relative. These pathways are divided into thematically-related psychoeducation steps to maximize the usability of the material. The content of these steps, which entail narrative examples, has been specifically designed to improve carer stress, e.g., by encouraging self-care and by targeting problematic appraisals known to increase carer stress. In addition, the content of the steps have been influenced by social cognition concepts of “agency” and self-efficacy in family life. The steps and pathways entail regular prompts to users to share their reactions to material with other users through a series of “talking points”. Users’ responses populate the content of the social networking newsfeed. In addi
|
Primary Outcome(s)
|
Perceived stress - Perceived Stress Scale[Baseline, 3 month and 6 month follow up]
|
Secondary Outcome(s)
|
Loneliness - UCLA Loneliness Scale[Baseline, 6 month follow up]
|
Self-Compassion - Self-Compassion Scale Short Form [Baseline, 6 month follow up]
|
Cost-effectiveness - AQoL 8D and Resource Use Questionnaire[Baseline, 6 month follow up]
|
Expressed emotion - Family Questionnaire[Baseline, 6 month follow up]
|
Altitudes Usability Questionnaire[6 month timepoint]
|
Communication and the quality of the relationship of carers and their young person - Parent- Adolescent Communication Scale[Baseline, 6 month follow up]
|
Impact of the illness on the family - Experience of Care-giving Inventory [Baseline, 6 month follow up]
|
Objective/chronic stress - hair cortisol[Baseline, 6 month follow up]
|
Depression - Center for Epidemiologic Studies Depression Scale-Revised [Baseline, 6 month follow up]
|
Satisfaction with Life - Satisfaction With Life Scale [Baseline, 6 month follow up]
|
Dynamic carer stress - Smartphone Ecological Momentary Assessment (SEMA) tool[Baseline, 6 month follow up]
|
Mental Health Continuum Short Form [Baseline, 6 month follow up]
|
Strengths use - Strengths Use Scale [Baseline, 6 month follow up]
|
Worry - Penn State Worry Questionnaire [Baseline, 6 month follow up]
|
Self-efficacy - "Me as a Parent” Questionnaire[Baseline, 6 month follow up]
|
Coping - Ways of Coping scale [Baseline, 6 month follow up]
|
Mindfulness - Mindful Attention Awareness Scale[Baseline, 6 month follow up]
|
Perceived social support - Medical Outcomes Study: Social Support Survey [Baseline, 6 month follow up]
|
Substance use - Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) version 3.0[Baseline, 6 month follow up]
|
Source(s) of Monetary Support
|
Australian Catholic University Research Fund
|
Ethics review
|
Status: Approved
Approval date: 19/01/2018
Contact:
University of Western Australia Human Research Ethics Committee
|
Status: Not approved
Approval date:
Contact:
Alfred Health HREC
|
Status: Not approved
Approval date:
Contact:
Western Australia Department of Health South Metropolitan Health Service HREC
|
Results
|
Results available:
|
Yes |
Date Posted:
|
14/03/2023 |
Date Completed:
|
10/07/2020 |
URL:
|
|
|
|