NCT03917329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 29, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

9 months

First QC Date

November 6, 2018

Last Update Submit

March 24, 2020

Conditions

Keywords

ParentsEducation staffTeachersIntellectual DisabilityLearning DisabilityPositive Behaviour SupportAcceptance and Commitment TherapyGroup TherapyChildrenPsychological Distress

Outcome Measures

Primary Outcomes (1)

  • Depression Anxiety and Stress Scale 21 item (DASS-21)

    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.

    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).

Secondary Outcomes (3)

  • Copenhagen Burnout Inventory (CBI)

    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).

  • Comprehensive Assessment of Acceptance and Commitment Therapy Processes (ComPACT)

    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).

  • Challenging Behaviour Self-Efficacy Scale (CBSES)

    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).

Other Outcomes (1)

  • Workshop Evaluation Measure (WEM)

    Post-intervention (at two weeks, day 15, at the end of the third group session).

Study Arms (1)

ACT and PBS group workshop

OTHER

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

Interventions

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.

ACT and PBS group workshop

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CAMHS-LD, NHS Lothian

Edinburgh, Midlothian, EH9 2AR, United Kingdom

Location

Edinburgh City Council

Edinburgh, various, United Kingdom

Location

Related Publications (4)

  • Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative research in psychology, 3(2), 77-101.

    BACKGROUND
  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PMID: 17695343BACKGROUND
  • 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.

    BACKGROUND
  • McConachie DA, McKenzie K, Morris PG, Walley RM. Acceptance and mindfulness-based stress management for support staff caring for individuals with intellectual disabilities. Res Dev Disabil. 2014 Jun;35(6):1216-27. doi: 10.1016/j.ridd.2014.03.005. Epub 2014 Mar 28.

    PMID: 24685937BACKGROUND

MeSH Terms

Conditions

BehaviorBurnout, ProfessionalIntellectual DisabilityLearning Disabilities

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersCommunication Disorders

Study Officials

  • Corinne Reid, MPsych, PhD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2018

First Posted

April 17, 2019

Study Start

March 29, 2019

Primary Completion

December 16, 2019

Study Completion

December 16, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations