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Evaluation of an ACT and PBS Group for Parents and Education Staff

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ClinicalTrials.gov Identifier: NCT03917329
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:

Parents and education staff who work with children with intellectual disabilities (ID) are known to be at a higher risk of experiencing psychological distress. This study evaluates whether a therapeutic group for parents and education staff who work with children with ID is effective in reducing psychological distress and if so, how it does this and who it works for. The group will include two components: an Acceptance and Commitment Therapy (ACT) section and a section about positive behaviour support (PBS). ACT is a psychological therapy, the aim of which is to help people to live their lives based on what matters to them, whilst learning new ways of managing difficult thoughts and feelings.

The PBS section aims to help participants to learn how to use positive strategies to reduce challenging behaviour. Both interventions have been shown to be effective on their own, but this study will examine if combining the two is helpful. Parents of children with ID and education staff who work closely with children with ID attending chosen schools or learning disability child and adolescent mental health services in NHS Lothian will be invited to participate in the study. The group will take place on three half days. Participants will complete questionnaires on the first and last day of the group and six weeks after it has finished. The questionnaires will be about psychological distress, confidence in caring for children with ID and seeing if the group changed how they cope with thoughts and feelings. Participants will also be invited to a focus group, which will think about if the intervention was helpful, and if so how it helped. If the group is effective, the investigators would hope to research the intervention in more depth with the aim of it being offered more widely in the future.


Condition or disease Intervention/treatment Phase
Intellectual Disabilities With Other Behavioral Symptoms Acceptance Processes Psychological Distress Burnout, Professional Self Efficacy Other: ACT and PBS group workshop Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will take part in a three session Acceptance and Commitment Therapy and Positive Behaviour Support group workshop and a focus group at a six week follow-up point. Pre-intervention, post-intervention and follow-up quantitative outcome questionnaire data will be gathered.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of an ACT and PBS Group for Parents and Education Staff of Children and Young People With an Intellectual Disability
Actual Study Start Date : March 29, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ACT and PBS group workshop
The intervention in this study is an Acceptance and Commitment Therapy (ACT) and Positive Behaviour Support (PBS) group workshop for parents and education staff of children with intellectual disabilities.
Other: ACT and PBS group workshop
Acceptance and Commitment Therapy and Positive Behaviour Support Group Workshop. Three sessions of approximately three hour duration. Groups will consist of 5-10 parents or 5-10 members of education staff. The group will include both didactic and experiential elements.




Primary Outcome Measures :
  1. Depression Anxiety and Stress Scale 21 item (DASS-21) [ Time Frame: Pre-intervention (day 1, immediately before first group session), Post-intervention (at two weeks, day 15, at the end of the third group session) and at a six-week follow up (before the focus group). ]
    The DASS-21 is a 21 item outcome measure of psychological distress, and as such can measure change in psychological distress when multiple measurements are taken. The DASS-21 has three subscales of depression (range 0-21), anxiety (range 0-20) and stress (range 0-21), where higher scores are indicative of higher levels of psychological distress. The scores are multiplied by two to be comparable to the longer form of this measure, the DASS-42.


Secondary Outcome Measures :
  1. Copenhagen Burnout Inventory (CBI) [ Time Frame: Pre-intervention (day 1, immediately before first group session), Post-intervention (at two weeks, day 15, at the end of the third group session) and at a six-week follow up (before the focus group). ]
    The CBI is a 19 item outcome measure of burnout and as such measures changes in burnout. The CBI has three subscales of personal burnout (range 0-100), work related burnout (range 0-100), and client related burnout (range 0-100). In each subscale, scores 50-74 are indicative of moderate burnout, scores 75-99 are indicative of high levels of burnout, and a score of 100 is indicative of severe levels of burnout.

  2. Comprehensive Assessment of Acceptance and Commitment Therapy Processes (ComPACT) [ Time Frame: Pre-intervention (day 1, immediately before first group session), Post-intervention (at two weeks, day 15, at the end of the third group session) and at a six-week follow up (before the focus group). ]
    ComPACT is a 23 item outcome measure of ACT processes and as such measures changes in ACT processes over time. ComPACT has a range of possible scores between 0 and 138, where higher scores are indicative of higher levels of psychological flexibility. The measure has three subscales - openess to experience (range 0-60), behavioural awareness (range 0-30) and valued action (range 0 to 48).

  3. Challenging Behaviour Self-Efficacy Scale (CBSES) [ Time Frame: Pre-intervention (day 1, immediately before first group session), Post-intervention (at two weeks, day 15, at the end of the third group session) and at a six-week follow up (before the focus group). ]
    CBSES is a 5 item outcome measure of self-efficacy for managing challenging behaviour, and as such measures changes in this self-efficacy over time. The range of scores is 0 to 35, where higher scores are indicative of higher levels of self-efficacy for managing challenging behaviours in children with learning disabilities.


Other Outcome Measures:
  1. Workshop Evaluation Measure (WEM) [ Time Frame: Post-intervention (at two weeks, day 15, at the end of the third group session). ]
    The WEM is a 9 item outcome measure devised to evaluate the workshop. The WEM has five likert scale items and four free text open question items. The measure is likely to be examined item by item, rather than by items being summed. Higher scores in each item are indicative of higher levels of engagement or satisfaction with the workshop. Each likert scale item has a possible range of scores from 0 to 6.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • Temporary staff members (contract remaining of less than six months).
  • Parents or Education Staff aged less than 18 years old.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917329


Contacts
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Contact: Shannon Connolly, MSc 00447976067210 shannon.connolly@nhslothian.scot.nhs.uk
Contact: Douglas McConachie, DClinPsy douglas.mcconachie@nhslothian.scot.nhs.uk

Locations
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United Kingdom
CAMHS-LD, NHS Lothian Recruiting
Edinburgh, Midlothian, United Kingdom, EH9 2AR
Contact: Shannon Connolly, MSc    00447724526681    s1583511@ed.ac.uk   
Contact: Douglas McConachie, DclinPsy       douglas.mcconachie@nhslothian.scot.nhs.uk   
Edinburgh City Council Recruiting
Edinburgh, United Kingdom, various
Contact: Shannon Connolly, MSc    00447724526681    s1583511@ed.ac.uk   
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
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Principal Investigator: Corinne Reid, MPsych, PhD University of Edinburgh
  Study Documents (Full-Text)

Documents provided by University of Edinburgh:
Informed Consent Form: Parent Consent Form  [PDF] December 17, 2018


Publications:
Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative research in psychology, 3(2), 77-101.
Cunningham, J. B., & McCrum-Gardner, E. (2007). Power, effect and sample size using GPower: Practical issues for researchers and members of research ethics committees. Evidence Based Midwifery, 5(4), 132-136.

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03917329     History of Changes
Other Study ID Numbers: 251260
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Edinburgh:
Parents
Education staff
Teachers
Intellectual Disability
Learning Disability
Positive Behaviour Support
Acceptance and Commitment Therapy
Group Therapy
Children
Psychological Distress

Additional relevant MeSH terms:
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Intellectual Disability
Behavioral Symptoms
Burnout, Professional
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Occupational Stress
Occupational Diseases
Burnout, Psychological
Stress, Psychological