An Evaluation of an ACT and PBS Group for Parents and Education Staff of Children and Young People With an Intellectual Disability
Phase: NA
Conditions: Intellectual Disabilities With Other Behavioral Symptoms, Acceptance Processes, Psychological Distress, Burnout, Professional, Self Efficacy
Sponsor: University of Edinburgh

Evaluation of an ACT and PBS Group for Parents and 
Education Staff 
V 3.0 25.02.2019 
IRAS Project ID: 251260 
 
 
 
Non-CTIMP Study Protocol 
An Evaluation of an ACT and PBS Group for Parents and Education Staff 
of Children and Young People with an Intellectual Disability 
 
The University of Edinburgh and Lothian Health Board 
ACCORD 
The Queen’s Medical Research Institute 
47 Little France Crescent 
Edinburgh 
EH16 4TJ 
Protocol authors 
Shannon Connolly 
Chief Investigator 
Dr Corinne Reid 
Sponsor number 
CAHSS1809/09 
REC Number 
18/SS/0159 
Version Number and Date 
v 3.0 25.02.2019  
 
 
 
 
 
 
 

Evaluation of an ACT and PBS Group for Parents and 
Education Staff 
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IRAS Project ID: 251260 
 
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CONTENTS 
 
1        INTRODUCTION ........................................................................................ 1 
1.1 
BACKGROUND ................................................................................. 1 
2 
STUDY OBJECTIVES ................................................................................ 4 
2.1 
OBJECTIVES .................................................................................... 4 
2.1.1 
Primary Objective ............................................................................ 4 
2.1.2 
Secondary Objectives ..................................................................... 4 
2.2 
ENDPOINTS ...................................................................................... 4 
2.2.1 
Primary Endpoint ............................................................................ 4 
2.2.2 
Secondary Endpoints ...................................................................... 4 
3 
STUDY DESIGN ......................................................................................... 5 
4 
STUDY POPULATION ............................................................................... 5 
4.1 
NUMBER OF PARTICIPANTS ........................................................... 5 
4.2 
INCLUSION CRITERIA ...................................................................... 5 
4.3 
EXCLUSION CRITERIA ..................................................................... 5 
4.4 
CO-ENROLMENT .............................................................................. 6 
5 
PARTICIPANT SELECTION AND ENROLMENT ...................................... 6 
5.1 
IDENTIFYING PARTICIPANTS ......................................................... 6 
5.2 
CONSENTING PARTICIPANTS ........................................................ 6 
5.2.1 
Withdrawal of Study Participants ..................................................... 7 
6 
STUDY ASSESSMENTS ........................................................................... 7 
6.1 
STUDY ASSESSMENTS ................................................................... 7 
6.2 
LONG TERM FOLLOW UP ASSESSMENTS .................................... 7 
7 
DATA COLLECTION ................................................................................. 7 
7.1 
MEASURES ....................................................................................... 7 
7.2 
SOURCE DATA DOCUMENTATION ................................................. 9 
8 
STATISTICS AND DATA ANALYSIS ...................................................... 10 
8.1 
SAMPLE SIZE CALCULATION ........................................................ 10 
8.2 
PROPOSED ANALYSES ................................................................. 10 
9 
ADVERSE EVENTS ................................................................................. 10 
10 
OVERSIGHT ARRANGEMENTS ............................................................. 10 
10.1 
INSPECTION OF RECORDS .......................................................... 10 
10.2 
RISK ASSESSMENT ....................................................................... 11 
10.3 
STUDY MONITORING AND AUDIT ................................................. 11 
11 
GOOD CLINICAL PRACTICE .................................................................. 11 
11.1 
ETHICAL CONDUCT ....................................................................... 11 
11.2 
INVESTIGATOR RESPONSIBILITIES ............................................. 11 
11.2.1 Informed Consent ......................................................................... 11 
11.2.2 Study Site Staff ............................................................................. 12 
11.2.3 Investigator Documentation ........................................................... 12 
11.2.4 GCP Training ................................................................................ 12 

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11.2.5 Confidentiality ............................................................................... 12 
11.2.6 Data Protection ............................................................................. 13 
12 
STUDY CONDUCT RESPONSIBILITIES ................................................. 13 
12.1 
PROTOCOL AMENDMENTS ........................................................... 13 
12.2 
MANAGEMENT OF PROTOCOL NON-COMPLIANCE ................... 13 
12.3 
SERIOUS BREACH REQUIREMENTS ........................................... 14 
12.4 
STUDY RECORD RETENTION ....................................................... 14 
12.5 
END OF STUDY .............................................................................. 14 
12.6 
CONTINUATION OF TREATMENT FOLLOWING THE END OF 
STUDY ............................................................................................ 14 
12.7 
INSURANCE AND INDEMNITY ....................................................... 14 
13 
REPORTING, PUBLICATIONS AND NOTIFICATION OF RESULTS ...... 15 
13.1 
AUTHORSHIP POLICY ................................................................... 15 
14 
REFERENCES ......................................................................................... 15 
 

Evaluation of an ACT and PBS Group for Parents and 
Education Staff 
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LIST OF ABBREVIATIONS 
ACCORD 
Academic and Clinical Central Office for Research & Development - Joint 
office for The University of Edinburgh and Lothian Health Board 
ACT 
Acceptance and Commitment Therapy 
AE 
Adverse Event 
ASD 
Autism Spectrum Disorder 
CI 
Chief Investigator 
CB 
Challenging Behaviour  
CBI 
Copenhagen Burnout Inventory 
CBSES 
Challenging Behaviour Self Efficacy Scale 
ComPACT 
Comprehensive Assessment of Acceptance and Commitment Therapy 
Processes  
CRF 
Case Report Form 
CYP-ID 
Children and Young People with an Intellectual/Learning Disability 
DASS-21 
Depression Anxiety and Stress Scale (21 item version) 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonisation 
ID 
Intellectual Disability 
PI 
Principal Investigator 
PBS 
Positive Behaviour Support  
QA 
Quality Assurance 
RCT 
Randomised Controlled Trial 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SAR 
Serious Adverse Reaction 
SOP 
Standard Operating Procedure 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TAU 
Treatment As Usual 
WEM 
Workshop Evaluation Measure 

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1 
INTRODUCTION 
1.1 
BACKGROUND 
The Scottish Mental Health Strategy 2017-2027 (Scottish Government, 2017) emphasises the 
need to improve the supports surrounding children, including focusing upon the quality of 
parent-child relationships, the school environment and provision of tier one and two mental 
health services. The strategy identifies that children and young people with intellectual 
disability (CYP-ID) and autism spectrum disorder (ASD) have the highest rates of mental 
health difficulties. Furthermore, up to 60% of CYP-ID present with challenging behaviour (CB; 
Adams & Allen, 2001) 
 
Challenging Behaviour  
 
CB is defined as “behaviour that puts the individual or others at risk and/or could lead to the 
limitation of an individual’s access to their community” (British Psychological Society, 2018, p. 
2). CBs, which can include aggression, self-injury and disruptive behaviours, have a 
significant impact on the child, their family and the services that support them (Fox et al., 
2002). Positive behaviour support (PBS) is widely accepted to be the best practice model to 
support CB (British Psychological Society, 2018). PBS aims to improve quality of life of 
individuals with intellectual disability in a values-based and person-centred manner (see Carr 
et al., 2002 for a review). 
 
Stress and Distress in Parents and Teachers  
 
However, PBS can be very demanding for the systems around young people to implement, 
especially in a consistent manner. Parents of children with an ID have been shown to have 
significantly higher rates of parenting stress and mental health difficulties (Hassall et al., 2005; 
Olsson & Hwaang, 2001), it is key that they are also provided with appropriate support so that 
they can implement the intensive PBS plans and have close, high-quality relationships with 
their children.  
 
Furthermore, teaching is amongst the occupations with the lowest levels of job satisfaction 
and highest stress levels (Johnson et al., 2005). Indeed, this appears to be an even greater 
issue within schools for CYP-ID, where a relationship between child behaviour difficulties and 
emotional exhaustion has been identified (Hastings & Brown, 2002). Considering that all 
education staff “have a responsibility to support the mental, emotional, social and physical 
wellbeing of pupils” (Scottish Government, 2017, p.13), they also require appropriate support 
and intervention to be able to do so, in the context of the high levels of stress they 
experience.  
 
Acceptance and Mindfulness-based Interventions 
 
Positively, there is a developing evidence base for the effectiveness of acceptance and 
mindfulness-based interventions for reducing the psychological stress and distress 
experienced by support staff, parents and teachers. Acceptance and Commitment Therapy 
(ACT), a third-wave of cognitive and behavioural therapies, was developed by Hayes, 
Strosahl and Wilson (1999). ACT supports individuals to live life based on their values, to 
willingly experience difficult emotions and to be able to step back and ‘defuse’ from difficult 
thoughts, with the aim to increase psychological flexibility (Blackledge & Hayes, 2006). 
Psychological flexibility is defined as “the capacity to persist or to change behaviour in a way 
that includes conscious and open contact with thoughts and feelings, appreciates what the 
situation affords, and serves one’s goals and values” (McCracken & Morley, 2014, p.225). 
Mindfulness is a core process within ACT but is also practiced within mindfulness-based 

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cognitive therapy and mindfulness-based stress reduction, which both also have well-
developed evidence bases (see Gu et al., 2015).  
 
ACT has often been described as a particularly appropriate intervention for parents and staff 
working with CYP-ID, given that their appraisal of the difficulties they face may often be 
realistic and thus perhaps less amenable to traditional cognitive behavioural strategies 
(Blackledge & Hayes, 2006). Recent meta-analyses of ACT have identified a developing 
evidence base for many psychological presentations, where ACT is superior to treatment as 
usual (TAU) and equivalent to cognitive-behavioural therapy (see A-Tjak et al., 2015; Öst, 
2014).  
 
Support Staff 
 
The evidence base for acceptance and mindfulness-based interventions for supporting 
systems around people with ID is most well-developed for support staff of adults with ID. A 
recent systematic review concluded that there is sufficient evidence for short term benefits for 
mindfulness-based interventions with paid support staff (Ó Donnchadha, 2018). However, the 
review identified that only three of the eight studies were of adequate quality, with others 
notably limited due to small sample sizes, and lack of appropriate follow-up and appropriate 
controls. Of note within the high-quality studies is an ACT group workshop intervention for 
support staff, with a randomised waitlist control design and six-week follow-up (McConachie 
et al., 2014). The results demonstrated a significant reduction in psychological distress in the 
ACT condition, with an increased effect for those with higher levels of distress at baseline. 
This study highlights the potential utility for this ‘dosage’ of ACT within this population.  
 
Teachers 
 
Within a teacher population, a relatively small RCT of an ACT workshop for early years 
education staff working with CYP-ID demonstrated improvements in teacher’s self-reported 
self-efficacy, willingness to experience emotion and mindfulness, although was not reported 
to improve ratings of depression (Biglan et al., 2013). While the study did not provide an 
active control with which to compare the ACT intervention, it provides preliminary evidence for 
the effectiveness and acceptability of ACT workshops with teachers working in special 
education environments.   
 
Parents  
 
Considering the provision of ACT to parents with CYP-ID, Blackledge and Hayes (2006) 
conducted an uncontrolled small study of a two-day ACT group workshop for parents of 
children with autism. The results identified significant improvements in depression and 
psychological distress both after the group and at a three-month follow-up. However, the 
changes could not be reliably attributed to the intervention in the absence of appropriate 
controls. Furthermore, Reid and colleagues (2016) qualitatively evaluated an ACT group for 
parents of children and young people with severe ID and challenging behaviour. The group 
was delivered in a workshop format with two days of four-hour groups. Themes identified from 
interviews suggested that participants had felt that they were at a “crunch point” (Reid et al., 
2016, p.9) before the intervention, that they had liked the focus on their own wellbeing and the 
group format. The authors acknowledged that they were unsure about the applicability of the 
group to parents of children with less severe ID, and highlighted that quantitative analysis was 
needed to measure changes in parents’ distress. Interestingly, this ACT intervention was 
delivered in the context of a service where PBS was also being provided. While the ACT 
intervention was not evaluated in this context, this is suggestive of the close link between the 
two interventions and how they may each increase the others effectiveness.  
 
The role for Positive Behavioural Support 
 

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Therefore, there is an argument for strengthening the ties between ACT and PBS when 
providing interventions to families.  Dunlap and Fox (2007) have argued that a key feature of 
PBS plans is the development of a parent-professional partnership, where parents function as 
collaborators in the development and implementation of the plan. This shift from the ‘expert 
model’ is of such significance because it is largely parents and teachers that implement PBS 
plans, and thus it is important that they have a high level of perceived self-efficacy for 
managing challenging behaviour. Where parents and teachers have been involved in the PBS 
process and their development of self-efficacy for managing challenging behavior has been 
supported, the intervention is more likely to socially valid and implemented (Dunlap & Fox, 
2007; Dunlap et al., 2001; Gore et al., 2013). However, research suggests that parents 
describe rarely experiencing partnership with professionals (Wodehouse & McGill, 2009). It is 
proposed that where professionals are the only ones to hold knowledge of PBS, this power 
imbalance is likely to remain (Proctor, 2008). Moreover, the recent NICE guidelines for the 
management of CB advises that families should be provided with “skills training and 
emotional support, or information about these, to help them take part in and support 
interventions for the person with a learning disability and behaviour that challenges” (2015, 
p.60).  
 
Interestingly, some work has begun on including PBS instruction in third-wave interventions 
within this population. Singh and colleagues (2014) completed a multiple baseline design 
study with three mothers of children with ASD who were displaying high levels of challenging 
behaviours. The mothers all previously had PBS plans that they had stopped implementing 
due to the associated stress this had caused. On completion of an eight-week mindfulness-
based PBS programme (MBPBS), the results identified statistically significant reductions in 
maternal stress and significant reductions in recorded incidents of challenging behaviour. This 
work was extended with a RCT with support staff of adults with ID, comparing MBPBS with 
TAU, applied behavioural analysis training (Singh et al., 2016). The findings identified that the 
MBPBS condition was significantly more effective than TAU in reducing staff stress, and 
reducing challenging behaviours, emergency medications and staff turnover.  
 
Current Study  
 
 
Considering the currently available research, it appears that there is a developing evidence 
base for ACT and mindfulness-based interventions for parents, teachers and support staff, 
and for mindfulness-based PBS for parents and support staff. However, it appears that there 
is yet to be a quantitatively evaluated parent ACT workshop or combined ACT and PBS-
based intervention. ACT and PBS are theoretically paired well together, in the context of their 
values focus and emphasis on increasing quality of life in a meaningful way. Given that 
parents and teachers both appear in need of access to these psychological interventions to 
support them in their distress and in their implementation of PBS, in this study, parents and 
teachers of CYP-ID will participate in a mixed methods study evaluating the effectiveness and 
mechanisms of an ACT and PBS based group workshop.  The workshop format should fit well 
within tier one and two mental health services and provide a sustainable way to systemically 
improving the wellbeing of children and young people with IDs and the caregivers around 
them. 
Quantitative Research Questions 
• 
Is an ACT and PBS based group workshop (“the intervention”) effective in reducing the 
psychological distress experienced by parents and teachers who work with children 
with IDs? 
• 
Is the intervention effective in increasing parents and education staff self-efficacy in 
managing children’s challenging behaviour? 
• 
Is the intervention effective in reducing education staff's self-reported experience of 
burnout? 
• 
Is there a significant change in the parents and education staff Acceptance and 
Commitment Therapy processes? 

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Qualitative Research Question  
• 
In which contexts and through which mechanisms does the group work to achieve 
these outcomes? 
Study Hypotheses  
• 
The intervention will be effective in significantly reducing the psychological distress self-
reported by parents and teachers who work with children with IDs. 
• 
The intervention will be effective in significantly increasing parents and education staff 
self-reported self-efficacy in managing children’s challenging behaviour. 
• 
The intervention will be effective in significantly reducing education staff's self-reported 
experience of burnout.  
 
Study Risks and Benefits 
The study will aim to ensure that all participants have capacity to give informed consent and 
that they are not pressured into participating. Confidentiality will be maintained where 
appropriate, with safeguarding measures in place to safely manage any disclosures that occur 
during the study. It is possible that by participating in the group, focus group or completing the 
study questionnaires, that participants may experience some distress. This will be safely 
managed by signposting participants and communicating with their GP as appropriate.  
However, participants also may benefit from the therapeutic group and consequently 
experience a reduction in psychological distress and a possible improvement in their child’s 
wellbeing. Participants may also derive some satisfaction from their involvement in the 
research.  
2 
STUDY OBJECTIVES 
2.1 
OBJECTIVES 
2.1.1 Primary Objective 
• 
To evaluate whether an ACT and PBS based workshop (“the intervention”) is effective 
in reducing the psychological distress experienced by parents and education staff who 
work with children with Intellectual Disability.  
2.1.2 Secondary Objectives 
• 
To evaluate whether the intervention is effective in increasing education staff and 
parents' self-efficacy in managing children’s challenging behaviour. 
• 
To evaluate whether the intervention is effective in reducing the self-reported burnout 
of education staff. 
• 
To examine in which contexts and through which mechanisms the group works to 
achieve these outcomes.  
2.2 
ENDPOINTS 
2.2.1 Primary Endpoint 
The primary outcome measure is the short form version of the Depression Anxiety and Stress 
Questionnaire (DASS-21).  
2.2.2 Secondary Endpoints 
The secondary outcome measures are as follows: 
• 
The Challenging Behaviour Self-Efficacy Scale (CBSES) 

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• 
Copenhagen Burnout Inventory (CBI) (Education staff only) 
• 
Comprehensive Assessment of Acceptance and Commitment Therapy Processes 
(ComPACT) 
• 
 Workshop Evaluation Measure (WEM) 
3 
STUDY DESIGN 
• 
The study has a mixed-methods design and draws upon a realist evaluation 
framework. The mixed methods approach allows the utilisation both quantitative and 
qualitative approaches to gain a greater level of detail than either one methodology 
would allow for individually, and for the results to support a firmer conclusion if the 
differing methodologies corroborate each other. The realist evaluation approach is a 
relatively new framework for research and aims to answer “what works for whom in 
what circumstances” (Pawson & Manzano-Santaella, 2012, p.177). Realist evaluation 
tends to critique randomised controlled trials and other evaluations as overly focused 
on aggregate outcomes which evaluate interventions in a binary way as successful or 
unsuccessful. Realist evaluation suggests that it might be more helpful to consider the 
context in which the intervention has been implemented and how this has interacted 
with mechanisms to produce the outcomes observed. This framework has been 
chosen to guide the mixed-methods approach in this study as it is particularly relevant 
given the complexity of delivering psychological interventions in this population, and 
the many factors that may influence their effectiveness. 
• 
Participants may be involved in the study for a period of approximately six months, 
due to the expectation that they may need to wait for a group appropriate to them to 
begin. Participants will be actively involved in the group for nine weeks, with three 
weeks of group sessions, and a focus group six weeks after this.  
• 
The study will take place in NHS Lothian buildings, schools or in community facilities.  
4 
STUDY POPULATION 
4.1 
NUMBER OF PARTICIPANTS 
• 
We will aim to recruit approximately 40 participants to the study (10 participants 
allocated to four groups). 
• 
Number of sites involved: 8 (LD-CAMHS and up to 7 schools for children with special 
educational needs).  
• 
Length of recruitment period: Estimated at approximately six to eight months.  
4.2 
INCLUSION CRITERIA 
• 
Parent or Guardian of a Child aged 5-18 with a diagnosis of an Intellectual 
Disability/Learning Disability and experience of challenging behaviour. 
• 
OR an employee working in a school for children with additional support needs, 
directly working with children with diagnosed Intellectual/Learning Disabilities. 
• 
Must speak English fluently. 
• 
Must be able to provide informed consent. 
4.3 
EXCLUSION CRITERIA 
• 
Temporary staff members (contract remaining of less than six months). 
• 
Parents or Education Staff aged less than 18 years old. 

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• 
Parents or Education staff that have a diagnosis of an ID, such that they would not be 
able to understand the group materials or questionnaires and complete them 
independently.  
• 
Individuals who are not able to provide informed consent.  
4.4 
CO-ENROLMENT 
 
Participants’ direct care team or school are likely to be aware of whether they are participating 
in other research. However, participants will additionally be routinely verbally asked about this 
during their discussion with study researchers, the direct care team or school. Where other 
studies are observational and questionnaire-based only in nature, this will be permitted. 
However, participants will not be permitted to take part in other intervention research during the 
duration of the study.  
5 
PARTICIPANT SELECTION AND ENROLMENT 
5.1 
IDENTIFYING PARTICIPANTS 
LD-CAMHS clinicians (members of the direct care team) will directly identify potential 
participants from patients currently on their caseloads. This may involve the patient file being 
reviewed by the clinician to ensure that the parents would meet the study inclusion criteria, 
and/or a telephone call or face to face discussion with potential participants. Clinicians will 
record their communication with potential participants, regarding the study, within the clinical 
notes. This will allow other clinicians within their care team to know if parents have already been 
approached.  
Schools will identify current staff members that may benefit from participating in the study. This 
may involve a review of staff files to identify whether they meet study inclusion criteria (e.g. that 
have employment contract of sufficient duration) but will not involve any review of their medical 
records. Schools may distribute study information sheets to staff members and ask them to 
discuss it with a named member of staff if interested in participating or may discuss with 
individual staff members who meet study criteria. Schools will also distribute information sheets 
to parents or guardians of children who attend the school, who meet the study criteria. This may 
involve review of files regarding the child/parent that the school may hold (but not their medical 
files).  
Flyers advertising the study, its group locations and times will be placed in the LD-CAMHS 
building and in school buildings (should the relevant management authorities wish to do so) 
and may be distributed to participants also. The flyers will serve to heighten awareness of the 
research study and as a reminder of the next group dates available. 
The direct care team and school staff will be informed of the study, and inclusion and exclusion 
criteria through meetings, emails and telephone calls as appropriate.  
5.2 
CONSENTING PARTICIPANTS 
The process of taking informed consent will be LD-CAMHS clinicians or senior education staff 
members providing the potential participant with the participant information sheet and 
discussing this with them. The participant information sheets for the study provide clear, easy 
to understand information to support potential participants making an informed decision where 
they are aware of the possible risks and benefits to participating. Considering the suggested 
heritability of milder forms of ID, it will be important to ensure that participants, particularly 
parents, have the capacity to give informed consent. This will be based on the referring 
clinician/school staff's judgement, as the individuals who will know the potential participants 
best. Potential participants will then take a minimum of 24hours to decide whether to participate 
in the study or not, to try to reduce any pressure they may feel regarding their participation. 
Should participants decide to take part in the study, they will be asked to return their completed 

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contact details form to their clinician or senior education staff member who discussed the study 
with them. It will be made clear that by completing and returning the form, they are consenting 
to these details being passed to the study research team who will contact them to discuss the 
study. When the study research team receive the contact details form, they will telephone the 
participant to discuss any questions they may have and to discuss their availability to attend a 
group. Before the beginning of the first group session, participants will complete the study 
consent form with the study researchers on an individual basis. This will ensure that the study 
research team can make sure that participants are fully informed about their decision to 
participate in the study.  
5.2.1 Withdrawal of Study Participants 
Participants are free to withdraw from the study at any point or a participant can be withdrawn 
by the Investigator. If withdrawal occurs, the primary reason for withdrawal will be documented 
in the participant’s case report form, if possible. The participant will have the option of 
withdrawal from  
 
(i) all aspects of the trial but continued use of data collected up to that point 
(ii) all aspects of the trial with removal of all previously collected data 
 
Participants who do not attend one or more of the group sessions will be welcome to attend the 
remaining sessions if they so wish but will be excluded from any relevant analyses. Participants 
may take part in the focus group if they have attended at least one group session. 
6 
STUDY ASSESSMENTS 
6.1 
STUDY ASSESSMENTS 
Participants will complete measures at three time points: before the first group session, after 
the last group session and before the focus group approximately six weeks after the last group 
session.  
6.2 
LONG TERM FOLLOW UP ASSESSMENTS 
Participants will be invited to take part in an hour-long focus group approximately six weeks 
after the therapeutic group has ended. This focus group will be facilitated by a researcher, 
who may be LD-CAMHS clinician, to reduce the impact of a social desirability bias in 
participants’ responses. Parents and education staff will attend separate focus groups. There 
will be no further follow-up after the focus group. Participants will be asked to complete the 
follow-up measures just before the focus group takes place. If participants do not attend the 
focus group, questionnaires will be posted to their home address with a return envelope 
provided, or they may return them to their LD-CAMHS clinician or participating school.  
7 
DATA COLLECTION 
7.1 
MEASURES 
Demographic Data 
A questionnaire will ask participants:  
• 
their child’s age, gender and diagnoses, 
• 
their own age and gender, 
• 
their attained education level and occupational status, 

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• 
whether the parent or education staff member has attended any relevant training or 
psychoeducation groups,  
• 
whether the person is the primary caregiver for the child and if there is another 
significant caregiver available to the child (if a parent; e.g. second residential parent, 
non-residential parent, residential grandparent) 
• 
number of years they have been in their role (if education staff). 
Depression Anxiety and Stress Scale -21 item (DASS-21) 
The DASS-21 is the short form measure of the Depression Anxiety and Stress Scale (Lovibond 
& Lovibond, 1995). The DASS-21 is widely used and has normative data available derived from 
a UK population sample (Henry & Crawford, 2005). The DASS-21 has three subscales of 
depression, anxiety and stress, with an underlying general factor of psychological distress 
(Henry & Crawford, 2005). The scale has been shown to have excellent internal reliability (α 
=0.93) and good convergent validity (Henry & Crawford, 2005). The DASS-21 has been chosen 
above the General Health Questionnaire-12 due to the criticism levelled at it regarding the 
possible impact of response bias on its psychometric integrity (Hankins, 2008) and as its 
suggested factors of anxiety/depression, social dysfunction and loss of confidence are not what 
is hoped to be captured by a measure of psychological distress in this study (Romppel et al., 
2013).  
Copenhagen Burnout Inventory (CBI; Borritz et al., 2006; for Education Staff only).  
The CBI is a nineteen-item measure consisting of three subscales of personal, client-related 
and work-related burnout. Burnout has been conceptualised as emotional, mental and physical 
exhaustion related to chronically high levels of emotional demand at work (Schaufeli & 
Greenglass, 2001). Burnout is included within this study for education staff as it is thought that 
burnout may capture a different aspect of the impact of the demands of working in a school for 
children with special educational needs beyond a measurement of psychological distress, and 
as burnout may feel more acceptable for education staff to report than psychological distress. 
The measure was developed in response to criticism of the Maslach Burnout Inventory, and 
has been validated for use with a general Danish workforce sample and samples of teachers 
from New Zealand and Italy (Borritz et al., 2006; Fiorilli et al., 2015; Milfont et al., 2008). The 
measure has been shown to have good internal reliability and construct validity (Borritz et al., 
2006; Mifont et al., 2008). 
Challenging Behaviour Self-Efficacy Scale (CBSES) 
Hastings and Brown (2002a) developed the CBSES as a five-item measure of self-efficacy 
related to managing challenging behaviours, with items such as “How confident are you in 
dealing with the challenging behaviours of the child/children you care for”. The measure is 
scored with a seven-point likert scale. In a sample of parents of children with autism and 
challenging behaviour, there was excellent internal reliability for mothers (α =0.94) and fathers 
(α =0.92). The measure has since been subject to a confirmatory factor analysis with Korean 
and US samples (Oh & Kozub, 2010), which identified a one factor model with adequate model 
fit and excellent internal reliability.  
Comprehensive Assessment of Acceptance and Commitment Therapy Processes 
(ComPACT)  
ComPACT is a recently developed 23 item ACT process measure (Francis et al., 2016). The 
measure was developed by consensus from experts, with an item pool derived from 11 other 
ACT process measures. It was developed due to the lack of a questionnaire that measured all 
aspects of ACT. For example, the Acceptance and Action Questionnaire (AAQ-II) has been 
argued to capture experiential avoidance and to neglect committed action (Francis et al., 2016). 
The ComPACT measure has demonstrated adequate internal consistency and good 
convergent and concurrent validity (Francis et al., 2016).  
Workshop Evaluation Measure (WEM) 
A brief measure will be devised on the basis of a previous social validity measure for an ACT 
based workshop (Bethay et al., 2013), with items such as “I have been consistently practicing 
the techniques and principles that I learned in the workshop” and “the workshop was interesting 

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and enjoyable”, rated on a seven point Likert scale ranging from completely disagree to 
completely agree. Open-ended items such as “what was the most helpful part of the workshop?” 
and “what was the least helpful part of the workshop?” will additionally be included to allow 
participants to flexibly express their experience of the intervention. This measure will be 
completed at the end of the third workshop session. Finally, all of these measures are free to 
use, and it is estimated that it will take participants up to fifteen minutes to complete this 
questionnaire battery. 
The following table details when participants will complete each questionnaire. 
  
Participant Type 
Group Session 1 
Group Session 3 
Focus Group/Postal 
Parents 
• 
Demographics 
• 
DASS-21 
• 
CBSES 
• 
ComPACT 
 
• 
DASS-21 
• 
CBSES 
• 
ComPACT 
• 
WEM 
 
• 
DASS-21 
• 
CBSES 
• 
ComPACT 
 
Education Staff 
• 
Demographics 
• 
DASS-21 
• 
CBI 
• 
CBSES 
• 
ComPACT 
 
• 
DASS-21 
• 
CBI 
• 
CBSES 
• 
ComPACT 
• 
WEM 
 
• 
DASS-21 
• 
CBI 
• 
CBSES 
• 
ComPACT 
 
 
7.2 
 SOURCE DATA DOCUMENTATION 
Source documents are those in which information is recorded and documented for the first 
time. 
Source 
Data  
Paper consent form 
Participant written informed consent 
Paper participant contact information sheet 
Participant contact details and GP contact 
details 
Medical notes – paper and electronic (Trak) 
Note from direct care team clinician recording 
date of provision of participant information 
sheet, and relevant information regarding 
participation in the study. 
School files/notes – paper and/or electronic 
Note from education staff recording date of 
provision of participant information sheet and 
relevant information regarding participation in 
the study.  
Audio file on an NHS audio recorder 
Audio recording of focus groups 
Paper questionnaires 
Questionnaire data 
Electronic database 
Electronic Anonymised Questionnaire Data 

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Electronic word files 
Anonymised transcripts of focus groups  
8 
STATISTICS AND DATA ANALYSIS 
8.1 
SAMPLE SIZE CALCULATION 
Power calculations were performed utilising G-Power 3.1 (Faul et al., 2007). The statistical 
analysis was set to be a with a within-between interaction, with two groups and three 
measurement points. The alpha level was set to 0.05 and power to 0.80, as per convention 
(Cunningham & McCrum-Gardner, 2007). The effect size previously reported for 
psychological distress in a similar study (McConachie et al., 2014) was medium to large. To 
be conservative, the power calculation for this study was performed with a medium effect size 
(f=0.25), which suggested a total sample size of 28 participants. Therefore, this study will aim 
to have four groups with ten participants each. This would mean recruiting 40 participants, 
with the expectation that 12 would be lost to attrition. 
8.2 
PROPOSED ANALYSES 
Summary Measures Reported 
The mean, standard deviation and range of the demographic variables and dependent variables 
will be reported. The percentage of missing data across the measures will also be reported.  
Methods of Analysis 
Regarding quantitative data, the statistical analysis will be completed using SPSS software. 
Data will be explored to ensure that test assumptions are met. Each dependent variable will 
then be analysed with repeated measures analyses of variance (ANOVA) with a within-between 
interaction, with significant effects further evaluated appropriately.  
Regarding qualitative data, the focus group interview transcripts will be analysed with thematic 
analysis, as per Braun and Clarke (2006). 
Management of Missing Data 
Should the level of missing data be minimal (<5%), the data will be assumed to be missing at 
random and a suitable method of imputation (most likely multiple imputation due to the small 
sample size) will be used to manage this appropriately.  
Should a higher level of missing data occur, the missing data will be analysed to examine 
whether it is missing at random or not. A suitable method of imputation will then be used.  
9 
ADVERSE EVENTS 
 
Should multiple participants present with high levels of persistent distress that appear to be 
related to participating in the group, this will be reviewed by the Chief investigator and 
researchers.  
 
10 
OVERSIGHT ARRANGEMENTS 
10.1 INSPECTION OF RECORDS 
Investigators and institutions involved in the study will permit trial related monitoring and audits 
on behalf of the sponsor, REC review, and regulatory inspection(s).  In the event of audit or 
monitoring, the Investigator agrees to allow the representatives of the sponsor direct access to 

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all study records and source documentation. In the event of regulatory inspection, the 
Investigator agrees to allow inspectors direct access to all study records and source 
documentation. Consent for this will be included in the Participant Consent Form.  
10.2 RISK ASSESSMENT 
A study specific risk assessment will be performed by representatives of the co-sponsors, 
ACCORD monitors and the QA group, in accordance with ACCORD governance and 
sponsorship SOPs. Input will be sought from the Chief Investigator or designee. The outcomes 
of the risk assessment will form the basis of the monitoring plans and audit plans. The risk 
assessment outcomes will also indicate which risk adaptions (delete if no adaptations were 
possible) could be incorporated into to trial design. 
10.3 STUDY MONITORING AND AUDIT 
The ACCORD Sponsor Representative will assess the study to determine if an independent 
risk assessment is required.  If required, the independent risk assessment will be carried out 
by the ACCORD Quality Assurance Group to determine if an audit should be performed 
before/during/after the study and, if so, at what frequency. 
Risk assessment, if required, will determine if audit by the ACCORD QA group is required. 
Should audit be required, details will be captured in an audit plan. Audit of Investigator sites, 
study management activities and study collaborative units, facilities and 3rd parties may be 
performed. 
11 
GOOD CLINICAL PRACTICE 
11.1 ETHICAL CONDUCT 
The study will be conducted in accordance with the principles of the International Conference 
on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP). 
 
Before the study can commence, all required approvals will be obtained and any conditions of 
approvals will be met. 
11.2 INVESTIGATOR RESPONSIBILITIES 
The Investigator is responsible for the overall conduct of the study at the site and compliance 
with the protocol and any protocol amendments.  In accordance with the principles of ICH GCP, 
the following areas listed in this section are also the responsibility of the Investigator.  
Responsibilities may be delegated to an appropriate member of study site staff.   
11.2.1 Informed Consent 
The Investigator will be responsible for ensuring informed consent is obtained before any 
protocol specific procedures are carried out. The decision of a participant to participate in 
clinical research is voluntary and will be based on a clear understanding of what is involved. 
Participants will receive adequate oral and written information – appropriate Participant 
Information and Informed Consent Forms will be provided. The oral explanation to the 
participant will be performed by LD-CAMHS clinicians or senior members of education staff, 
and will cover all the elements specified in the Participant Information Sheet and Consent 
Form. 
 
The participant will be given every opportunity to clarify any points they do not understand 
and, if necessary, ask for more information. In particular, the participant will have the 
opportunity to ask questions after they have been provided with an oral explanation of the 
study and Participant Information Sheet, and the contact details of a study researcher will be 
included on the Participant Information Sheet, should they have any further questions. The 
participant will be given a minimum of 24 hours to consider the information before deciding 
whether or not they wish to provide consent to take part.  It will be emphasised to the 

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participant that they may withdraw their consent to participate at any time without loss of 
benefits to which they otherwise would be entitled. 
 
The participant will be informed and agree to their medical records being inspected by 
representatives of the sponsor(s). 
 
The Investigator or delegated member of the trial team and the participant will sign and date 
the Informed Consent Form(s) to confirm that consent has been obtained. The participant will 
receive a copy of this document and a copy filed in the Investigator Site File (ISF) and 
participant’s LD-CAMHS notes (if applicable). 
11.2.2 Study Site Staff 
The Investigator will be familiar with the protocol and the study requirements.  It will be the 
Investigator’s responsibility to ensure that all staff assisting with the study are adequately 
informed about the protocol and their trial related duties. 
11.2.3 Investigator Documentation 
The Principal Investigator will ensure that the required documentation is available in local 
Investigator Site files ISFs.  
11.2.4 GCP Training 
All researchers will be encouraged to undertake GCP training in order to understand the 
principles of GCP. GCP training status for all investigators will be indicated in their respective 
CVs.  
11.2.5 Confidentiality 
Participants’ confidentiality will be maintained by ensuring that any identifiable information 
collected during the study is not accessible by any non-NHS staff, with the identifiable 
information kept within NHS Lothian. Participants will be informed in the participant information 
sheet that all information is confidential, but that their GP will be notified that they are 
participating in the study and that should the researchers become aware that there is a risk of 
harm to the participant or to someone else their GP and other relevant professionals will be 
notified (e.g. Police Scotland; Social Work Services). We will manage the identification of 
suicidal ideation or other significant mental health difficulties in participants by providing the 
participant with suitable contact numbers for support after the group session and notifying their 
GP by phone. In instances where child protection concerns are identified, the Clinical 
Supervisor and relevant NHS Child Protection Liaison will be consulted as soon as possible, 
and Social Work Services contacted by phone as per NHS Lothian child protection guidelines 
if appropriate. In the unlikely event of the researcher being made aware of a serious crime, 
Police Scotland will be contacted by phone should this be deemed to be in the public interest, 
as per confidentiality/data protection guidelines.  
While given the group setting it may be difficult to ensure confidentiality is maintained by other 
participants, the importance of this will be emphasised at the beginning of each group and will 
be part of the “group rules”.  
Participants will complete paper measures, which will be transported from the data collection 
site to the NHS site in the locked boot of a car, which is insured for business use. All identifiable 
data will be held only within the NHS. Participants will be allocated a unique code to identify 
their data. Hard copies of participant consent forms and decode sheet (where the participant 
unique code identifiers will be recorded) will be kept in a separate locked cabinet from the hard 
copies of the participant questionnaires. Participants will be provided with questionnaire packs 
with a front sheet asking their name. Once the questionnaires are received back, the 
participants' unique code will be recorded on the questionnaires and the front sheet securely 
shredded. This is as we do not expect participants to know or remember their unique code 
when completing questionnaires. Therefore, the stored questionnaire data will be anonymous. 

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Identifiable electronic data (e.g. database of participants, audio recordings of the focus groups) 
will be held within a limited access folder on networked NHS servers, which are backed up 
regularly. Only the researcher and the clinical supervisor will have access to this folder. The 
anonymised database of questionnaire data and anonymised focus group transcripts will be 
held within the University of Edinburgh’s One Drive, a secure, password protected, regularly 
backed-up server that the university recommends for storing active research data. The 
anonymised data will be saved onto the researcher's University of Edinburgh One Drive server 
via the researcher’s nhs.net email address, which is accessible outside of the NHS computer 
network. This anonymized data  will only be accessed by the researcher and Academic 
Supervisor and a vpn will be used when accessing this data for security purposes. On 
completion of the study, all identifiable data will be securely deleted or shredded within three 
months. The anonymised data will be kept within the university for a period of ten years in the 
University Data Store, a data server designed to store archived research data, with a further 
review every five years after this if appropriate, as per university research handbook guidelines. 
The researcher, academic supervisor and clinical supervisor will all be named custodians of 
this data. 
11.2.6 Data Protection 
All Investigators and study site staff involved with this study will comply with the requirements 
of the Data Protection Act 2018 with regard to the collection, storage, processing and disclosure 
of personal information and will uphold the Act’s core principles. Access to collated participant 
data will be restricted to individuals from the research team treating the participants, 
representatives of the sponsor(s) and representatives of regulatory authorities. 
Computers used to collate the data will have limited access measures via user names and 
passwords. The audio-recorders used to record the focus groups will be NHS encrypted and 
password protected.  
Published results will not contain any personal data that could allow identification of individual 
participants. 
12 
STUDY CONDUCT RESPONSIBILITIES 
12.1 PROTOCOL AMENDMENTS 
Any changes in research activity, except those necessary to remove an apparent, immediate 
hazard to the participant in the case of an urgent safety measure, must be reviewed and 
approved by the Chief Investigator.   
Amendments will be submitted to a sponsor representative for review and authorisation before 
being submitted in writing to the appropriate REC, and local R&D for approval prior to 
participants being enrolled into an amended protocol. 
12.2 MANAGEMENT OF PROTOCOL NON-COMPLIANCE 
Prospective protocol deviations, i.e. protocol waivers, will not be approved by the sponsors and 
therefore will not be implemented, except where necessary to eliminate an immediate hazard 
to study participants. If this necessitates a subsequent protocol amendment, this should be 
submitted to the REC, and local R&D for review and approval if appropriate. 
Protocol deviations will be recorded in a protocol deviation log and logs will be submitted to the 
sponsors every 3 months. Each protocol violation will be reported to the sponsor within 3 days 
of becoming aware of the violation.  All protocol deviation logs and violation forms should be 
emailed to QA@accord.scot 
Deviations and violations are non-compliance events discovered after the event has occurred.  
Deviation logs will be maintained for each site in multi-centre studies.  An alternative frequency 
of deviation log submission to the sponsors may be agreed in writing with the sponsors. 

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12.3 SERIOUS BREACH REQUIREMENTS 
A serious breach is a breach which is likely to effect to a significant degree: 
(a) the safety or physical or mental integrity of the participants of the trial; or 
(b) the scientific value of the trial. 
If a potential serious breach is identified by the Chief investigator, Principal Investigator or 
delegates, the co-sponsors (seriousbreach@accord.scot) must be notified within 24 hours.  It 
is the responsibility of the co-sponsors to assess the impact of the breach on the scientific value 
of the trial, to determine whether the incident constitutes a serious breach and report to research 
ethics committees as necessary.  
12.4 STUDY RECORD RETENTION 
All study documentation will be kept for 10 years from the protocol defined end of study point. 
When the minimum retention period has elapsed, study documentation will not be destroyed 
without permission from the sponsor. 
12.5 END OF STUDY 
The end of study is defined as the last participant’s last visit.   
The Investigators or the co-sponsor(s) have the right at any time to terminate the study for 
clinical or administrative reasons.  
The end of the study will be reported to the REC, and R+D Office(s) and co-sponsors within 90 
days, or 15 days if the study is terminated prematurely. The Investigators will inform participants 
of the premature study closure and ensure that the appropriate follow up is arranged for all 
participants involved. End of study notification will be reported to the co-sponsors via email to 
resgov@accord.scot.  
A summary report of the study will be provided to the REC within 1 year of the end of the study. 
12.6 CONTINUATION OF TREATMENT FOLLOWING THE END OF 
STUDY 
There is no planned continued provision of the intervention after the study has concluded. The 
intervention will not be further provided to participants as participants will be considered to have 
completed the intervention, and as they will continue to receive their treatment as usual from 
their care providers, if applicable. 
12.7 INSURANCE AND INDEMNITY 
The co-sponsors are responsible for ensuring proper provision has been made for insurance or 
indemnity to cover their liability and the liability of the Chief Investigator and staff. 
The following arrangements are in place to fulfil the co-sponsors' responsibilities: 
• 
The Protocol has been designed by the Chief Investigator and researchers employed 
by the University and collaborators.  The University has insurance in place (which 
includes no-fault compensation) for negligent harm caused by poor protocol design 
by the Chief Investigator and researchers employed by the University. 
• 
Sites participating in the study will be liable for clinical negligence and other negligent 
harm to individuals taking part in the study and covered by the duty of care owed to 
them by the sites concerned.  The co-sponsors require individual sites participating 
in the study to arrange for their own insurance or indemnity in respect of these 
liabilities. 

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• 
Sites which are part of the United Kingdom's National Health Service will have the 
benefit of NHS Indemnity. 
13 
REPORTING, PUBLICATIONS AND NOTIFICATION OF 
RESULTS 
13.1 AUTHORSHIP POLICY 
Ownership of the data arising from this study resides with the study team.  
14 
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