Clinical trial NCT06691711: Adult-caregiver Supported Positive Psychology Intervention to Increase Resilience: Work Package 2
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Lead sponsor: Norfolk and Suffolk NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: University of Sussex
First posted: 2024-11-15
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Waitlist controlled
Primary purpose: PREVENTION

Brief summary: The goal of this feasibility study was to investigate a new intervention designed to help parents/carers of children aged 8-12 who have experienced adversities to build their child's resilience to mental health difficulties using a 'positive psychology' approach. The research questions concerned the acceptability, feasibility and safety of the intervention.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intervention feasibility / fidelity of delivery
timeFrame: 10 weeks
measure: Potential risks of the intervention
timeFrame: 10 weeks
measure: Intervention acceptability
timeFrame: 10 weeks
measure: Intervention feasibility / fidelity of delivery
timeFrame: 20 weeks
measure: Potential risks of the intervention
timeFrame: 20 weeks
measure: Intervention acceptability
timeFrame: 20 weeks
Secondary outcomes:
measure: Me and My Feeling Questionnaire
timeFrame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
measure: The Student Resilience Survey
timeFrame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
measure: Students' Life Satisfaction Scale
timeFrame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
measure: Strengths and Difficulties Questionnaire (parent-report version)
timeFrame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
measure: Me as a Parent
timeFrame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
measure: Short Warwick Edinburgh Mental Wellbeing Scale
timeFrame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Suffolk NHS Foundation Trust
state: Norfolk
Study officials:
References: