Mental HealthASPIRENCT06691711
Adult-caregiver Supported Positive Psychology Intervention to Increase Resilience: Work Package 2
A study testing ASPIRE support package in people with Mental Health, run by Norfolk and Suffolk NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- ASPIRE support package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jan 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Suffolk NHS Foundation Trust
Norwich, Norfolk, NR6 5BE
About this study
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
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.
Read the 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.
- Conditions
- Mental Health
- Being tested
- ASPIRE support package
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASPIRE support packageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention | Experimental | 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). Receives: Behavioral: ASPIRE support package |
| Waitlist | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Intervention feasibility / fidelity of delivery
ASPIRE intervention adherence checklist
Measured: 10 weeks
Potential risks of the intervention
Modified Edinburgh Adverse Effects of Psychological Therapy Scale
Measured: 10 weeks
Intervention acceptability
Qualitative acceptability of the intervention from the perspective of children, caregivers and professionals, assessed via interviews and focus groups
Measured: 10 weeks
Intervention feasibility / fidelity of delivery
ASPIRE intervention adherence checklist
Measured: 20 weeks
Potential risks of the intervention
Modified Edinburgh Adverse Effects of Psychological Therapy Scale
Measured: 20 weeks
Intervention acceptability
Qualitative acceptability of the intervention from the perspective of children, caregivers and professionals, assessed via interviews and focus groups
Measured: 20 weeks
Secondary outcomes (6)
Me and My Feeling Questionnaire
16-item measure of mental health difficulties with emotional and behavioural difficulties subscale (child completed)
Measured: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
The Student Resilience Survey
47-item measure measuring children's perceptions of their internal and external resilience (child completed)
Measured: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
Students' Life Satisfaction Scale
7-item measure of global life satisfaction (child completed)
Measured: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
Strengths and Difficulties Questionnaire (parent-report version)
25-item measure of caregiver perception of their child's emotional and behavioural difficulties (parent/carer completed)
Measured: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
Me as a Parent
16-item measure of parental self-regulation, including their self-efficacy, personal agency, self-management and self-sufficiency as a parent (parent/carer completed)
Measured: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
Short Warwick Edinburgh Mental Wellbeing Scale
7-item measure of the parent or carer's mental wellbeing (parent/carer completed)
Measured: Post intervention (10 weeks) & 20 week follow-up for immediate arm only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start31 Jan 2022
- Primary completion27 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Waitlist controlled
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norfolk and Suffolk NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, University of Sussex
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691711
- Sponsor's protocol ID
- ASPIRE WP2
- Acronym
- ASPIRE
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06691711
- Acronym / sponsor ID
- ASPIRE / ASPIRE WP2
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Norfolk and Suffolk NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Oxford, University of Sussex
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist controlled
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention | Experimental | Behavioral: ASPIRE support packageThose 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). |
| Waitlist | No intervention | –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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASPIRE support packageThe 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. | Behavioural | Immediate intervention |
Primary outcome
Intervention feasibility / fidelity of delivery
Time frame: 10 weeks
ASPIRE intervention adherence checklist
Potential risks of the intervention
Time frame: 10 weeks
Modified Edinburgh Adverse Effects of Psychological Therapy Scale
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
Intervention feasibility / fidelity of delivery
Time frame: 20 weeks
ASPIRE intervention adherence checklist
Potential risks of the intervention
Time frame: 20 weeks
Modified Edinburgh Adverse Effects of Psychological Therapy Scale
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
6 secondary outcomes
Me and My Feeling Questionnaire
Time frame: 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
Students' Life Satisfaction Scale
Time frame: 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
Me as a Parent
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASPIRE support package in people with Mental Health, run by Norfolk and Suffolk NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention feasibility / fidelity of delivery (time frame: 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.