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

November 14, 2024 updated by: Norfolk and Suffolk NHS Foundation Trust

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

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR6 5BE
        • Norfolk and Suffolk NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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).
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.
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.

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
10 weeks
Potential risks of the intervention
Time Frame: 10 weeks
Modified Edinburgh Adverse Effects of Psychological Therapy Scale
10 weeks
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
10 weeks
Intervention feasibility / fidelity of delivery
Time Frame: 20 weeks
ASPIRE intervention adherence checklist
20 weeks
Potential risks of the intervention
Time Frame: 20 weeks
Modified Edinburgh Adverse Effects of Psychological Therapy Scale
20 weeks
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
20 weeks

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
16-item measure of mental health difficulties with emotional and behavioural difficulties subscale (child completed)
Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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)
Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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)
Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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)
Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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)
Post intervention (10 weeks) & 20 week follow-up for immediate arm only
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)
Post intervention (10 weeks) & 20 week follow-up for immediate arm only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2022

Primary Completion (Actual)

September 27, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

October 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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