Supporting Family Carers' Mental Health

Queen's University Belfast

Status: Enrolling

Conditions: Feasibility

Treatments: Behavioral: Carers-ID online support programme; Behavioral: Carers-ID online support programme - Wait-list control

Study type: Interventional

Funder types: Other

Identifiers

NCT05737823

MHLS 23_04

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Carers-ID online support programme

Experimental group

Description:

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.

Treatment:

Behavioral: Carers-ID online support programme

Wait-list Control

Other group

Description:

Wait-list control arm

Treatment:

Behavioral: Carers-ID online support programme - Wait-list control