Clinical trial NCT05737823: Supporting Family Carers' Mental Health
Official title: Randomised Controlled Feasibility Study and Exploratory Trial of the Carers-ID Intervention: Supporting Family Carers' Mental Health Following the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Feasibility
Keywords: Family carer
Intellectual disabilities
Feasibility
Mental health
Intervention
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Baily Thomas Charitable Fund
name: University of Glasgow
name: University of Sheffield
name: University of South Wales
First posted: 2023-02-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Methodology:

Family carers (n = 120) will be randomised to receive the programme (n=60) or assigned to a wait-list control (n=60) group. The intervention (Carers-ID) 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. Participants (n=12) who have taken part in the intervention arm of the research will be invited to participate in the process evaluation.

Outcome:

1. Retention of Subjects in Study Assessments (\>80% of family carers)
2. Recruitment of Subjects into Study (\>90 carers)
3. Acceptability and feasibility of the outcome measures (\>80% of family carers)
4. Depression, Anxiety and Stress Scale - 21; The Warwick-Edinburgh Mental Well-being Scale; The Resilience Scale; and The Social Connectedness Scale Revised.

Number of participants to be enrolled: 120 family carers

Main inclusion criteria: Participants will be UK adults \>18 years of age and will be caring for a family member with an intellectual disability.

Statistical Analysis: Descriptive statistics will be used to summarise baseline data including demographic variables and questionnaire responses. Inferential statistics (t-tests or ANOVA) will be used as indicators of difference between the intervention and control arms and will be used to determine effect sizes for sample size calculation in a future phase III trial.

Study duration: 24 months


Eligibility criteria: Inclusion Criteria:

* Resident of the UK;
* \>18 years of age;
* Caring for a family member with an intellectual disability.

Primary outcomes:
measure: Retention of Subjects in Study Assessments
timeFrame: 3 months
measure: Recruitment of Subjects Into Study
timeFrame: 3 months
measure: Acceptability and feasibility of the outcome measures
timeFrame: 6 months
Secondary outcomes:
measure: Depression, Anxiety and Stress Scale - 21 (DASS-21)
timeFrame: Baseline (T0), 2 weeks (T1), 3 months (T2)
measure: The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
timeFrame: Baseline (T0), 2 weeks (T1), 3 months (T2)
measure: The Resilience Scale (RS-25)
timeFrame: Baseline (T0), 2 weeks (T1), 3 months (T2)
measure: The Social Connectedness Scale Revised
timeFrame: Baseline (T0), 2 weeks (T1), 3 months (T2)
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
state: Antrim
Study officials:
References: