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FeasibilityNCT05737823

Supporting Family Carers' Mental Health

A study testing Carers-ID online support programme in people with Feasibility, run by Queen's University, Belfast at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Feasibility
What is being tested?
Carers-ID online support programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited Kingdom
Study dates
12 May 2023to 30 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Mark Linden, PhD contact

028 9097 2233

m.linden@qub.ac.uk

Rachel Leonard, PhD contact

rachel.leonard@qub.ac.uk

United Kingdom1 site, 1 recruiting

  • Queen's University Belfast

    Belfast, Antrim, BT7 1NN

    Mark Linden, PhD, m.linden@qub.ac.uk

    Rachel Leonard, PhD, rachel.leonard@qub.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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.

Read more

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

Conditions
Feasibility
Being tested
Carers-ID online support programme, Carers-ID online support programme - Wait-list control
Keywords
Family carer, Intellectual disabilities, Feasibility, Mental health, Intervention
Medical subject headings
Intellectual Disability, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carers-ID online support programmeBehavioural

    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 controlBehavioural

    The same programme as above delivered to the wait-list control after the T2 follow-up data has been collected.

Study groups in NCT05737823
Study groupRoleWhat they receive
Carers-ID online support programmeExperimentalParticipants in this arm will receive access to the Carers-ID online programme. Participants will be able to access the online programme for 2 weeks.
Receives: Behavioral: Carers-ID online support programme
Wait-list ControlOtherWait-list control arm
Receives: Behavioral: Carers-ID online support programme - Wait-list control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention of Subjects in Study Assessments

    Retain 80% of intervention and control participants

    Measured: 3 months

  2. Recruitment of Subjects Into Study

    Sufficient recruitment is set as >90 family carers.

    Measured: 3 months

  3. Acceptability and feasibility of the outcome measures

    Acceptability and feasibility of the outcome measures determined by process evaluation (>80% of family carers).

    Measured: 6 months

Secondary outcomes (4)

  1. 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.

    Measured: Baseline (T0), 2 weeks (T1), 3 months (T2)

  2. 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.

    Measured: Baseline (T0), 2 weeks (T1), 3 months (T2)

  3. 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.

    Measured: Baseline (T0), 2 weeks (T1), 3 months (T2)

  4. 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.

    Measured: Baseline (T0), 2 weeks (T1), 3 months (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start12 May 2023
  3. Primary completion30 Jul 2024 (estimated)
  4. Study completion30 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05737823
Sponsor's protocol ID
MHLS 23_04
Status last verified
Jun 2023
First submitted
10 Feb 2023
Last updated
23 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD will be made available in publications and open access databases.

Publications

  • Leonard RA, Truesdale M, Brown M, Marsh L, Todd S, Hughes N, Forbes T, Crowe A, Linden MA. A randomised controlled feasibility study of the Carers-ID intervention to support the mental health of family carers of people with intellectual disabilities. PLoS One. 2026 Mar 20;21(3):e0345096. doi: 10.1371/journal.pone.0345096. eCollection 2026.

    PubMed 41860835

  • 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.

    PubMed 38321576

Questions about this trial

What is this clinical trial studying?

A study testing Carers-ID online support programme in people with Feasibility, run by Queen's University, Belfast at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mark Linden, PhD (028 9097 2233, m.linden@qub.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention of Subjects in Study Assessments (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05737823, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.

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