Supporting Family Carers' Mental Health

Feasibility Clinical Trial

Official title:

Randomised Controlled Feasibility Study and Exploratory Trial of the Carers-ID Intervention: Supporting Family Carers' Mental Health Following the COVID-19 Pandemic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05737823
• Other study ID #: MHLS 23_04
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: June 2023
• Source: Queen's University, Belfast
• Contact: Mark Linden, PhD
• Phone: 028 9097 2233
• Email: m.linden[@]qub.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 30, 2025
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Resident of the UK;

• >18 years of age;

• Caring for a family member with an intellectual disability.

Related Conditions & MeSH terms

• Feasibility

Intervention

Behavioral:
• Carers-ID online support programme
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.
• Carers-ID online support programme - Wait-list control
The same programme as above delivered to the wait-list control after the T2 follow-up data has been collected.

Locations

Country	Name	City	State
United Kingdom	Queen's University Belfast	Belfast	Antrim

Sponsors (5)

Lead Sponsor	Collaborator
Queen's University, Belfast	Baily Thomas Charitable Fund, University of Glasgow, University of Sheffield, University of South Wales

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention of Subjects in Study Assessments	Retain 80% of intervention and control participants	3 months
Primary	Recruitment of Subjects Into Study	Sufficient recruitment is set as >90 family carers.	3 months
Primary	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	Depression, Anxiety and Stress Scale - 21 (DASS-21)	The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, with 21 items in total. Items are rated on a 4 point Likert scale, from 'Did not apply to me at all' to 'Applied to me very much or most of the time'.; Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items and multiplying by 2, with potential scores ranging from 0 to a maximum of 42. With higher scores indicating increased severity of emotional state.	Baseline (T0), 2 weeks (T1), 3 months (T2)
Secondary	The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)	The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) was developed to enable the measurement of mental wellbeing. The WEMWBS is a 14-item scale of positively worded statements covering feeling and functioning aspects of mental wellbeing. The 14-statements have five response categories from 'none of the time' to 'all of the time'.; The WEMWBS is scored by summing the scores for each of the 14 items, which are scored from 1 to 5. Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.	Baseline (T0), 2 weeks (T1), 3 months (T2)
Secondary	The Resilience Scale (RS-25)	The 25 Item Resilience Scale was developed as a general measure of resilience for adults across the lifespan.; Participants respond by either agreeing or disagreeing with the statements on a scale of 1(disagree) to 7 (agree). The responses are summed (min 25 to max 175) and a higher score reflects stronger resilience.	Baseline (T0), 2 weeks (T1), 3 months (T2)
Secondary	The Social Connectedness Scale Revised	This 20-item scale is used to assess the extent to which persons feel connected to others in their surrounding social area. It is on a Likert scale with 1 being strongly disagree to 6 being strongly agree.; The negatively worded items are reverse scored and summed together with the positively worded items to create a scale score with a possible range from 20 to 120. An item mean score with a possible range from 1 to 6 can also be calculated by dividing the total scale score by 20 (or the number of scale items). Higher scores on the SCS-R reflect a stronger sense of social connectedness.	Baseline (T0), 2 weeks (T1), 3 months (T2)

External Links

•   Carers-ID webpage