Distressing sensory experiences? (DSE) Mental and Behavioural Disorders
Conditions
Interventions
The trial will be a single-blind parallel-group RCT with two arms:
1. Brief psychological intervention involving four sessions of talking therapy for the children/young people with distressing sensory
T1) at which point participants will also be invited to take part in qualitative interviews, and 6 months post-randomisation (T2).
Sponsors
Greater Manchester Mental Health NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
8 Years to 99 Years
Inclusion criteria
Inclusion criteria: Young people and their parent/parent pair (i.e., children and parent/carer dyads) will be eligible if: 1. The child is aged 8-15-years-old and self-identifies as experiencing DSE: due to the current lack of sensitivity of diagnostic or clinical threshold assessments of DSEs, young people who have been referred to CAMHS will automatically be considered eligible for inclusion if they report the presence of DSEs, which will be confirmed by the MAVIC 2. The child is currently under the care of CAMHS 3. At least one parent, primary carer or legal guardian provides consent for trial participation, and in line with Health Research Authority guidance for Research Involving Children, the child provides assent for inclusion into the trial
Exclusion criteria
Exclusion criteria: Children and parent/carer dyads will be excluded when: 1. Young people unable to engage in conversational English, as the intervention and trial assessments are currently only available in English. If a parent is unable to take part in the PTP, the young person can still engage in the young person’s ChUSE intervention. 2. The child experiences a mental health crisis requiring inpatient hospital admission at the time of study enrolment. The intervention is designed to be accessed as an early intervention on an outpatient basis, so those accessing inpatient CAMHS services will not be eligible for inclusion as they may have urgent clinical needs. 3. The child is already enrolled in another mental health clinical trial involving the provision of an active psychological treatment, as concomitant trial participation may be excessively burdensome and influence outcome assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The principal feasibility outcomes will be: 1. Trial recruitment measured using study data to calculate the number of family units recruited and randomised per month 2. Trial retention measured using study data to calculate % of participants retained at each assessment point 3. Treatment engagement measured using study data to calculate the number of sessions attended by CYP and parents/carers allocated to the ChUSE intervention + TAU and TAU arm of the trial) at the end of the study 4. ChUSE intervention treatment fidelity measured using study data to calculate the extent to which the trial therapist can deliver the ChUSE intervention with high levels of treatment fidelity) at the end of the study 5. The safety of the ChUSE intervention for young people and parents/caregivers measured using information collected via detailed Adverse Event (AE) forms (e.g., number of AE and SAE related and unrelated to trial procedures and interventions) at the end of the study 6. The uptake of the parent training programme measured using treatment engagement data (i.e., number of parents who accept the PTP offer and number of sessions attended parents/carers) at the end of the study 7. The feasibility of collecting key outcome measures to inform the selection and data collection procedures for the future definitive trial measured using the completeness (i.e. % of missing responses and reasons for missingness) of the aforementioned and below outcome measures at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be evaluated at baseline, T1 (three months), and T2 (six months) using a range of self-report measures collected from both children and young people (CYP) and their parents/guardians: The ‘promise of efficacy’ of the ChUSE intervention and the necessary parameters to inform a sample size calculation for a future efficacy trial. Measures for CYP: 1. Symptom Level measured using: 1.1. Manchester Voices Inventory for Children (MAVIC) 1.2. Unusual Experiences Questionnaire (UEQ) 1.3. Brief Self-compassion Scale 2. Health-related quality of life outcomes measured using: 2.1. Stirling Children’s Wellbeing Scale 2.2. EQ-5D-Y 2.3. KidCOPE scale 2.4. Child Health Utility Instrument (CHU-9D) 2.5. Strengths and Difficulties Questionnaire Self-Report version for 11-17 year olds Measures for parents/guardians: 1. Health-related quality of life outcomes measured using: 1.1. SDQ-parent version 1.2. Adult Wellbeing Scale (parents/carers) 1.3. Parental Stress Scale (PSS), an 18-item questionnaire assessing parents' feelings about their parenting role, exploring positive [e.g. demands on resources, feelings of stress] 1.4. Coping Health Inventory for Parents (CHIP) 1.5. EQ-5D | — |
Countries
England, United Kingdom
Contacts
Public ContactSarah Parry
Outcome results
None listed