Supporting Family Carers' Mental Health

June 21, 2023 updated by: Dr Mark Linden, Queen's University, Belfast

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carers-ID online support programme
Participants in this arm will receive access to the Carers-ID online programme. Participants will be able to access the online programme for 2 weeks.
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.
Other: Wait-list Control
Wait-list control arm
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention of Subjects in Study Assessments
Time Frame: 3 months
Retain 80% of intervention and control participants
3 months
Recruitment of Subjects Into Study
Time Frame: 3 months
Sufficient recruitment is set as >90 family carers.
3 months
Acceptability and feasibility of the outcome measures
Time Frame: 6 months
Acceptability and feasibility of the outcome measures determined by process evaluation (>80% of family carers).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression, Anxiety and Stress Scale - 21 (DASS-21)
Time Frame: Baseline (T0), 2 weeks (T1), 3 months (T2)

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)
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time Frame: Baseline (T0), 2 weeks (T1), 3 months (T2)

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)
The Resilience Scale (RS-25)
Time Frame: Baseline (T0), 2 weeks (T1), 3 months (T2)

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)
The Social Connectedness Scale Revised
Time Frame: Baseline (T0), 2 weeks (T1), 3 months (T2)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University, Belfast

Collaborators

University of Sheffield
University of Glasgow
University of South Wales
Baily Thomas Charitable Fund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2023

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MHLS 23_04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD will be made available in publications and open access databases.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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