Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737823
Status:
RECRUITING
Last Update Posted:
2023-06-23
First Post:
2023-02-10
Brief Title:
Supporting Family Carers Mental Health
Sponsor:
Queens University Belfast
Organization:
Queens University Belfast
Study Overview
Official Title:
Randomised Controlled Feasibility Study and Exploratory Trial of the Carers-ID Intervention Supporting Family Carers Mental Health Following the COVID-19 Pandemic
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n60 or assigned to a wait-list control n60 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 n12 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
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 n60 or assigned to a wait-list control n60 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 n12 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None