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Completed

NCT Number: NCT06691711

Adult-caregiver Supported Positive Psychology Intervention to Increase Resilience: Work Package 2

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.

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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norfolk and Suffolk NHS Foundation Trust

Norwich, Norfolk, NR6 5BE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASPIRE support package

Behavioral

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.

Primary outcomes

  1. Intervention feasibility / fidelity of delivery

    Time frame: 10 weeks

    ASPIRE intervention adherence checklist

  2. Potential risks of the intervention

    Time frame: 10 weeks

    Modified Edinburgh Adverse Effects of Psychological Therapy Scale

  3. Intervention acceptability

    Time frame: 10 weeks

    Qualitative acceptability of the intervention from the perspective of children, caregivers and professionals, assessed via interviews and focus groups

  4. Intervention feasibility / fidelity of delivery

    Time frame: 20 weeks

    ASPIRE intervention adherence checklist

  5. Potential risks of the intervention

    Time frame: 20 weeks

    Modified Edinburgh Adverse Effects of Psychological Therapy Scale

  6. Intervention acceptability

    Time frame: 20 weeks

    Qualitative acceptability of the intervention from the perspective of children, caregivers and professionals, assessed via interviews and focus groups

Secondary outcomes

  1. Me and My Feeling Questionnaire

    Time frame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only

    16-item measure of mental health difficulties with emotional and behavioural difficulties subscale (child completed)

  2. The Student Resilience Survey

    Time frame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only

    47-item measure measuring children's perceptions of their internal and external resilience (child completed)

  3. Students' Life Satisfaction Scale

    Time frame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only

    7-item measure of global life satisfaction (child completed)

  4. Strengths and Difficulties Questionnaire (parent-report version)

    Time frame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only

    25-item measure of caregiver perception of their child's emotional and behavioural difficulties (parent/carer completed)

  5. Me as a Parent

    Time frame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only

    16-item measure of parental self-regulation, including their self-efficacy, personal agency, self-management and self-sufficiency as a parent (parent/carer completed)

  6. Short Warwick Edinburgh Mental Wellbeing Scale

    Time frame: Post intervention (10 weeks) & 20 week follow-up for immediate arm only

    7-item measure of the parent or carer's mental wellbeing (parent/carer completed)

Sponsors and collaborators

Lead sponsor

Norfolk and Suffolk NHS Foundation Trust

Other

Collaborators

  • University of Oxford
  • University of Sussex

Registry information

Official study 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

Acronym: ASPIRE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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