NCT06691711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
Last Updated

November 15, 2024

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

October 11, 2023

Last Update Submit

November 14, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Intervention feasibility / fidelity of delivery

    ASPIRE intervention adherence checklist

    10 weeks

  • Potential risks of the intervention

    Modified Edinburgh Adverse Effects of Psychological Therapy Scale

    10 weeks

  • Intervention acceptability

    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

    ASPIRE intervention adherence checklist

    20 weeks

  • Potential risks of the intervention

    Modified Edinburgh Adverse Effects of Psychological Therapy Scale

    20 weeks

  • Intervention acceptability

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

    20 weeks

Secondary Outcomes (6)

  • Me and My Feeling Questionnaire

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

  • The Student Resilience Survey

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

  • Students' Life Satisfaction Scale

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

  • Strengths and Difficulties Questionnaire (parent-report version)

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

  • Me as a Parent

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

  • +1 more secondary outcomes

Study Arms (2)

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).

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.

Interventions

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.

Immediate intervention

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norfolk and Suffolk NHS Foundation Trust

Norwich, Norfolk, NR6 5BE, United Kingdom

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Waitlist controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

November 15, 2024

Study Start

January 31, 2022

Primary Completion

September 27, 2022

Study Completion

September 30, 2022

Last Updated

November 15, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations