Supporting Family Carers' Mental Health
Randomised Controlled Feasibility Study and Exploratory Trial of the Carers-ID Intervention: Supporting Family Carers' Mental Health Following the COVID-19 Pandemic
1 other identifier
interventional
120
1 country
1
Brief Summary
Brief Summary: Background: Feasibility and acceptability of the Carers-ID intervention to improve mental health outcomes in family carers of people with intellectual disabilities. Objective:
- 1.To conduct a Phase II feasibility randomised controlled trial and process evaluation of the Carers-ID programme.
- 2.To determine the acceptability of outcome measures of stress, anxiety, depression, resilience and well-being in assessing the impact of the programme on family carers.
- 3.To determine the recruitment and retention rates of participants in the trial.
- 4.To identify potential effect sizes and estimate appropriate sample size for use in an effectiveness trial.
- 5.To determine if progression to a phase III effectiveness trial is warranted.
- 6.Retention of Subjects in Study Assessments (\>80% of family carers)
- 7.Recruitment of Subjects into Study (\>90 carers)
- 8.Acceptability and feasibility of the outcome measures (\>80% of family carers)
- 9.Depression, Anxiety and Stress Scale - 21; The Warwick-Edinburgh Mental Well-being Scale; The Resilience Scale; and The Social Connectedness Scale Revised.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
May 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2025
CompletedJune 23, 2023
June 1, 2023
1.2 years
February 10, 2023
June 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Retention of Subjects in Study Assessments
Retain 80% of intervention and control participants
3 months
Recruitment of Subjects Into Study
Sufficient recruitment is set as \>90 family carers.
3 months
Acceptability and feasibility of the outcome measures
Acceptability and feasibility of the outcome measures determined by process evaluation (\>80% of family carers).
6 months
Secondary Outcomes (4)
Depression, Anxiety and Stress Scale - 21 (DASS-21)
Baseline (T0), 2 weeks (T1), 3 months (T2)
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Baseline (T0), 2 weeks (T1), 3 months (T2)
The Resilience Scale (RS-25)
Baseline (T0), 2 weeks (T1), 3 months (T2)
The Social Connectedness Scale Revised
Baseline (T0), 2 weeks (T1), 3 months (T2)
Study Arms (2)
Carers-ID online support programme
EXPERIMENTALParticipants in this arm will receive access to the Carers-ID online programme. Participants will be able to access the online programme for 2 weeks.
Wait-list Control
OTHERWait-list control arm
Interventions
The Carers-ID online programme, which consists of ten modules which cover topics including: promoting resilience, reducing anxiety, managing stress, accessing local supports, managing family conflict and information for siblings who are carers.
The same programme as above delivered to the wait-list control after the T2 follow-up data has been collected.
Eligibility Criteria
You may qualify if:
- Resident of the UK;
- \>18 years of age;
- Caring for a family member with an intellectual disability.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's University, Belfastlead
- Baily Thomas Charitable Fundcollaborator
- University of Glasgowcollaborator
- University of Sheffieldcollaborator
- University of South Walescollaborator
Study Sites (1)
Queen's University Belfast
Belfast, Antrim, BT7 1NN, United Kingdom
Related Publications (1)
Linden MA, Leonard R, Forbes T, Brown M, Marsh L, Todd S, Hughes N, Truesdale M. Randomised controlled feasibility study protocol of the Carers-ID online intervention to support the mental health of family carers of people with intellectual disabilities. Pilot Feasibility Stud. 2024 Feb 6;10(1):25. doi: 10.1186/s40814-024-01448-w.
PMID: 38321576DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Random allocation to the intervention and control conditions will be undertaken by an independent third party not involved with the research. Members of the research team will be blind to allocation to reduce selection bias.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Reader
Study Record Dates
First Submitted
February 10, 2023
First Posted
February 21, 2023
Study Start
May 12, 2023
Primary Completion
July 30, 2024
Study Completion
March 30, 2025
Last Updated
June 23, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
All collected IPD will be made available in publications and open access databases.