An open randomised feasibility trial of the equipping youth to help one another treatment programme

The primary outcome measure will be a proxy measure of behavioural problems called the Emotion Problems Scale -Behaviour Rating Scales [EPS-BRS; 23]. The EPS-BPS is a 135-item questionnaire which asks respondents questions about the behaviour of the participant over the last month. The person completing the EPS-BPS must know the participant well, and for this trial, this will be a member of the nursing team. They will be asked to rate how frequently the participants engages in various behaviours. The EPS-BRS is comprised of 12 subscales:
1. Thought/behaviour disorder
2. Verbal aggression
3. Sexual maladjustment
4. Non-compliance
5. Hyperactivity
6. Distractibility
7. Anxiety
8. Somatic concerns
9. Withdrawal
10. Depression
11. Low self-esteem
Four subscales are summed to form the Externalising Behaviour Problems Scale, while three subscales are summed to form the Internalising Behaviour Problems Scale.

Participants who provide consent will be asked to complete assessment measures within a four week period following randomisation, and then again at 16 weeks after randomisation.

Secondary outcome measures:
1. Moral development: the Sociomoral Reflection Measure (SRM-SF) is a production measure of moral reasoning and has been shown to possess high levels of test-retest reliability, and excellent internal consistency. The measure comprises eleven questions, and generally takes about twenty minutes to present. The questions relate to the following seven constructs:
1.1.Contract (questions one to three)
1.2. Truth (question four)
1.3. Affiliation (questions five and six)
1.4. Life (questions seven and eight)
1.5. Property (question nine)
1.6. Law (question ten)
1.7. Legal Justice (question eleven)
Verbatim answers to the questions are scored according to a set of rules and heuristics, and the development of proficient and reliable scoring occurs through the use of practice scoring material. Responses to each question are assigned a developmental rating which corresponds to a moral stage associated with Gibb’s Socio-Moral Reasoning Theory,
2. Emotional Problems: the Emotion Problems Scale – Self Report Inventory (EPS-SRI) is a 147-item self-report questionnaire designed for use with people with IDDs. The questionnaire has six subscales:
2.1. Positive impression
2.2. Thought/behaviour disorder
2.3. Impulse control
2.4. Anxiety
2.5. Low self-esteem
2.6. Depression
3. Distorted Cognitions: The How I Think (HIT) Questionnaire is a measure of cognitive distortions based upon the four-categories. These are:
3.1. Self-Centred
3.2. Blaming Others
3.3. Minimizing/Mislabelling
3.4. Assuming the Worst
Total and mean scores are derived for the four-categories of distorted thinking as well as four behavioural referent subscales:
3.5.. Opposition-Defiance
3.6. Physical Aggression
3.7. Lying
3.8. Stealing
An Anomalous Responding scale is also calculated, along with three Summary Scales:
3.9. Overt Scale
3.10. Covert Scale
3.11.Total Score
The Overt Scale is calculated from the Opposition-Defiance and Physical Aggression subscales, while the Covert Scale is calculated from the Lying and Stealing subscales. The total score is calculated from all subscales
4. Social Problem Solving: the Social Problem Solving Inventory Revised is a 25-item self-report inventory that assesses general problem solving style, and it has been adapted for use with people with IDDs
5. Health Economics: Estimation of cost-effectiveness, within a health-technology assessment, is an iterative process. Here we aim to monitor levels of resource-use and quality of life (QoL), to inform the decision as to how costs and benefits would be measured in any future more definitive study. The NICE methods guide recommends that costs are calculated from the perspective of the NHS and personal social services (PSS). Within this feasibility we will thereby seek to monitor levels of resource-use associated with the intervention, including face-to-face contact with a trained therapist and any training/manual provided to supporters/carers, and the use of other NHS and PSS resource-items, including therapy received by the control arms as part of TAU, medication use, in-patient services and health professional visits (e.g. GP/physiotherapist). Appropriate unit costs (e.g. Curtis) will subsequently be attached to all items of resource-use. The NICE methods guide recommends the use of QALYs (Quality Adjusted Life Year) as part of a health technology assessment. We plan to use the EQ-5D-5L to estimate the quality of life component of the QALY in this population group, where both self-complete and proxy versions are available. We will also collect data on Health Service Resource Use and more general details about the hospital or secure unit in which people are living. Analysis: the main purpose of the analysis is to inform how the decision as to how the above data on costs and effects would be collected within a more definitive study. Thus, we will estimate completion rates and seek to identify big cost drivers, in order to inform this decision. The cost of the intervention will also be estimated. Additionally, though the results of this will need to be treated with caution, a preliminary cost-effectiveness analysis will also be performed.

Additional Measures:
6. At four weeks following randomisation, participants will be asked to complete the Wechsler Abbreviated Scale of Intelligence – Second Edition. This is a short measure of general intellectual functioning. We will assess acceptability by randomly selecting 25% of our participants and inviting them to take part in semi structured interviews following the completion of the outcome assessments. We will examine views on several key areas, which include:
6.1. Accessibility of the intervention
6.2. Helpful and unhelpful aspects, including barriers to change
6.3. Understanding and usefulness of content
6.4. Relationships with professionals within treatment, and e) perceived effectiveness. We will also carry out these interviews with participants who were randomised to the control arm in order to try to capture contamination.

Participants who provide consent will be asked to complete assessment measures within a four week period following randomisation, and then again at 16 weeks after randomisation.