NCT06089447

Brief Summary

The study is investigating the feasibility and acceptability of the story-based intervention, The Shadows of Tallystick Valley, aimed at improving the psychological wellbeing and resilience of children and young people who are affected by familial substance use. A secondary aim of the study is to identify whether there is a 'signal of efficacy'. The early intervention is a story and activity book designed and developed by Book of Beasties, in collaboration with the charity Change Grow Live (CGL), who work directly with children and young people experiencing familial substance use. The intervention is used by s at CGL with children and young people engaged with the service. In the present study, we aim to evaluate the story-based intervention within a pilot randomised controlled trial. Participants will be randomised to either receive the intervention or to join a waitlist for the same intervention. The effects of the story-based intervention will be assessed using pre and post psychological well-being and resilience measures, including KidCOPE, the Stirling Children's Wellbeing Scale and the Child and Youth Resilience Measure. The primary outcome measures are concerned with overall psychological wellbeing.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

October 3, 2023

Last Update Submit

October 12, 2023

Conditions

Wellness, Psychological

Outcome Measures

Primary Outcomes (1)

  • Stirling Children's Wellbeing Scale (SCWBS)

    The Stirling Children's Wellbeing Scale (SCWBS) (Liddle and Carter, 2015) is a 15-item questionnaire measuring wellbeing.

    Two weeks

Secondary Outcomes (2)

  • KidCOPE

    Two weeks

  • Child and Youth Resilience Measure

    Two weeks

Study Arms (2)

Control Group

EXPERIMENTAL

Participants will receive the intervention immediately

Behavioral: A story based intervention called 'The Shadow of Tallystick Valley'

Waitlist Group

ACTIVE COMPARATOR

Participants will be allocated to a waitlist group and will receive the intervention aft 6 months.

Behavioral: A story based intervention called 'The Shadow of Tallystick Valley'

Interventions

A story based intervention called 'The Shadow of Tallystick Valley'BEHAVIORAL

'The Shadows of Tallystick Valley' is a story based intervention for CYP aged 7 - 14 years aimed at supporting the psychological wellbeing and resilience of those affected by familial substance misuse. It has been designed by Book of Beasties, a developer of games and educational content, in collaboration with the charity Change Grow Live, who support those experiencing substance misuse and CYP affected by familial substance misuse in the UK. The wellbeing resource harnesses protective factors, such as respectful and caring conversations with professionals (Wangansteen and Westby, 2019), to facilitate a safe and supportive environment aimed towards understanding the CYPs experience, support their psychological wellbeing and building resilience and coping skills. It uses fictional narratives, including characters that represent particular topics which act as drivers for engagement.

Control GroupWaitlist Group

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged between 7 - 14 years;
  • Child: 7 - 10
  • YP: 11 - 14
  • Able to read age appropriate materials independently;
  • Have someone in their family using alcohol and/or substances;
  • Have received parental/caregiver consent to take part in the study;
  • Have an assigned support worker

You may not qualify if:

  • They are below age 7 years or above 14 years;
  • They are currently engaging in self-harm, including all forms of self harm as set out by Mind (2020), and/or have plans to end their life;all forms of self harm
  • Have not given consent to take part in the study;
  • Have not received parent or caregiver consent to take part in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Location

Related Publications (5)

  • Beets MW, von Klinggraeff L, Weaver RG, Armstrong B, Burkart S. Small studies, big decisions: the role of pilot/feasibility studies in incremental science and premature scale-up of behavioral interventions. Pilot Feasibility Stud. 2021 Sep 10;7(1):173. doi: 10.1186/s40814-021-00909-w.

    PMID: 34507624BACKGROUND

  • Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.

    PMID: 26092476BACKGROUND

  • Information Commissioner's Office. (2018). Guide to the General Data Protection Regulation (GDPR). https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr

    BACKGROUND

  • Medical Research Council. (2012). Good research practice: Principles and guidelines. In MRC ethics series.

    BACKGROUND

  • Mind. (2020). Self Harm. Accessible via self-harm-2020.pdf (mind.org.uk)

    BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • India Smith

    Student

    PRINCIPAL INVESTIGATOR

Central Study Contacts

India Smith

CONTACT

07442256086i.smith@surrey.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The children and young people will not know which group they have been assigned to.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trainee Clinical Psychologist

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 18, 2023

Study Start

October 1, 2024

Primary Completion

April 1, 2025

Study Completion

September 1, 2025

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Anonymised data may be shared outside of the research team for research purposes. Participants will be asked to provide written consent (either electronically or in hard copy) for their anonymous data to be shared in this way. Where an academic journal requires that the original data is made available as per their publication terms, the research team will share only the anonymised data set - this type of data sharing will be covered under the consent form item related to 'data sharing for research purposes'. Data will not be shared with the parent or caregiver. Any requests to access the anonymised trial data should be made to the PI. Data must not be shared outside the research team without the permission of the PI. All members of the research team have been made aware of and have agreed to abide by this data sharing policy. The PI reserves the right to reject any requests to access the anonymised trial data.

Locations

GB(1)