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A Pilot Randomised Controlled Trial of Intervention for Children and Young People Experiencing Family Substance Use

NCT06089447 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-18

No results posted yet for this study

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.

Conditions

  • Wellness, Psychological

Interventions

BEHAVIORAL

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

'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.

Sponsors & Collaborators

  • University of Surrey

    lead OTHER

Principal Investigators

  • India Smith · Student

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2025-04-30
Completion
2025-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06089447 on ClinicalTrials.gov