- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06691711
Adult-caregiver Supported Positive Psychology Intervention to Increase Resilience: Work Package 2 (ASPIRE)
Adult-caregiver Supported Positive Psychology Intervention to Increase Resilience (ASPIRE): Developing and Refining a Caregiver-delivered Positive Psychology Intervention to Increase the Resilience of Children Who Have Experienced Adversities - Work Package 2
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Adverse Childhood Experiences (ACEs) are traumatic or stressful events before age 18 that have been linked to poor mental health across the life course. Resilience is the ability of an individual to maintain or return to a thriving state following adversity. As resilience is not a static trait, intervening to increase the resilience of children exposed to ACEs has the potential to decrease the risk of later mental health difficulties. Positive psychology interventions (i.e. interventions that aim to increase factors that have been identified as important to individual and community flourishing) have been shown to be effective in increasing resilience. However, there was not yet a positive psychology intervention designed to meet the needs of young people exposed to ACEs and their caregivers (parents/carers).
Objectives: To investigate the acceptability, feasibility and safety of a co-produced caregiver-delivered positive psychology intervention to enhance the resilience to mental health difficulties of children who have experienced ACEs.
Methods: The project was guided by a Stakeholder Research Team (SRT) comprising both adults and young people with relevant expertise-by-experience. The study was divided into two work packages. In work package 1, the researchers completed a component analysis of existing positive psychology interventions, and a qualitative study to understand the needs and preferences of young people, parents/carers and professionals. They then conducted a series of intervention development workshops to co-produce the intervention with the SRT, informed by the findings of the component analysis and qualitative study. In work package 2, the researchers carried out a waitlist-controlled feasibility study involving 12 families with a child aged 8-12 years who had experienced ACEs. Families were randomised to receive the intervention either immediately or after a 10-week waiting period and mixed methods data collected to enable us to assess the acceptability, feasibility and safety of the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Norfolk
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Norwich, Norfolk, United Kingdom, NR6 5BE
- Norfolk and Suffolk NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- The child's parent or carer identifies that their child has been significantly impacted by one or more Adverse Childhood Experience (ACE).
- Child is aged 8 to 12 years.
- Child is willing and able to provide informed assent to participate.
- The child's parent or carer is willing and able provide parental consent for their child's participation.
- At least one adult caregiver (aged 18+) is willing and able to provide informed consent to participate themselves.
Exclusion criteria:
- Child is currently under the care of specialist child and adolescent mental health services (CAMHS).
- There are ongoing safeguarding concerns that might have an impact on the family's ability to participate safely (e.g. ongoing abuse or neglect).
- The child or their caregiver has a learning disability that would prevent them from accessing the intervention or completing outcome measures (reasonable adjustments will be made to allow families to participate wherever possible).
In addition, professionals involved in supporting caregivers to deliver the intervention (ASPIRE facilitators) will be invited to participate as staff participants.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate intervention
Those allocated to the immediate arm will be offered the ASIRE support package over a 10 week period immediately post randomisation.
The caregiver will be provided with access to all module resources and supported through the programme by a trained practitioner (their ASPIRE facilitator) who offers information, advice and encouragement during the intervention period (providing up to 8 support sessions in total).
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The ASPIRE support package has a modular structure with core modules that all participating families are encouraged to complete initially, followed by optional modules which the family is supported to select from according to their strengths and needs.
Core modules provide psychoeducation for the caregiver and optional modules contain information on the selected positive psychology topic together with instructions for suggested activities to be completed by the caregiver with their child to implement evidence-based positive psychology strategies.
All resources can be accessed both electronically via an online portal or via the printed resource pack.
Each caregiver is supported through the programme by a trained practitioner who offers regular support sessions (up to 8 in total) to provide information, advice and encouragement.
Support sessions can take place face-to-face, by video call or over the phone according to participant preference.
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No Intervention: Waitlist
Participants randomised to the waitlist arm will not be denied access to any support or treatment available as part of current service provision during the waiting period.
Both young people and parents/carers will be encouraged to continue engaging with any support they already receive and can be referred/self-refer to additional services as required.
After the 10-week waiting period is complete, participants randomised to this arm will be offered the ASPIRE intervention as described above.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention feasibility / fidelity of delivery
Time Frame: 10 weeks
|
ASPIRE intervention adherence checklist
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10 weeks
|
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Potential risks of the intervention
Time Frame: 10 weeks
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Modified Edinburgh Adverse Effects of Psychological Therapy Scale
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10 weeks
|
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Intervention acceptability
Time Frame: 10 weeks
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Qualitative acceptability of the intervention from the perspective of children, caregivers and professionals, assessed via interviews and focus groups
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10 weeks
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Intervention feasibility / fidelity of delivery
Time Frame: 20 weeks
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ASPIRE intervention adherence checklist
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20 weeks
|
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Potential risks of the intervention
Time Frame: 20 weeks
|
Modified Edinburgh Adverse Effects of Psychological Therapy Scale
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20 weeks
|
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Intervention acceptability
Time Frame: 20 weeks
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Qualitative acceptability of the intervention from the perspective of children, caregivers and professionals, assessed via interviews and focus groups
|
20 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Me and My Feeling Questionnaire
Time Frame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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16-item measure of mental health difficulties with emotional and behavioural difficulties subscale (child completed)
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Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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The Student Resilience Survey
Time Frame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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47-item measure measuring children's perceptions of their internal and external resilience (child completed)
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Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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Students' Life Satisfaction Scale
Time Frame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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7-item measure of global life satisfaction (child completed)
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Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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Strengths and Difficulties Questionnaire (parent-report version)
Time Frame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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25-item measure of caregiver perception of their child's emotional and behavioural difficulties (parent/carer completed)
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Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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Me as a Parent
Time Frame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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16-item measure of parental self-regulation, including their self-efficacy, personal agency, self-management and self-sufficiency as a parent (parent/carer completed)
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Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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Short Warwick Edinburgh Mental Wellbeing Scale
Time Frame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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7-item measure of the parent or carer's mental wellbeing (parent/carer completed)
|
Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ASPIRE WP2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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