Effectiveness of a Pain Assessment and Management Program for Respite Workers Supporting Children With Disabilities

NCT03421795 | Completed

• 1 other identifier: REB16-12-696
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the impact of pain training delivery for respite care providers who support children with developmental disabilities on (a) pain assessment and management-related knowledge, (b) participant self-rated perceptions of the feasibility, confidence and skill in pain assessment and management, and (c) strategy use. Half of the participants will receive the pain training, while half will receive the training about family-centered care, and be offered the pain training after completion of the follow-up.

Conditions

Pain

Keywords

pain assessment/management; developmental disabilities; children; education; respite workers

Outcome Measures

Primary Outcomes (4)

• Within intervention group change from baseline in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised

  Pain-related knowledge assessment

  Baseline (within 30 minutes prior to start of training), Post (within 30 minutes after completion of training)

• Within intervention group change (i.e., maintenance) from post in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised

  Pain-related knowledge assessment

  Post (within 30 minutes after completion of training), Follow-Up (approximately one month after training)

• Between group difference in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised

  Pain-related knowledge assessment

  Post (within 30 minutes after completion of training)

• Between group difference in scores on Questionnaire for Understanding Pain in Individuals with Intellectual and Developmental Disabilities - Revised

  Pain-related knowledge assessment

  Follow-Up (approximately one month after training)

Secondary Outcomes (24)

• Between group difference in ratings of the feasibility of pain assessment

  Post (within 30 minutes after completion of training)

• Between group difference in ratings of the feasibility of pain assessment

  Follow-Up (approximately one month after training)

• Between group difference ratings of the feasibility of pain management

  Post (within 30 minutes after completion of training)

• Between group difference ratings of the feasibility of pain management

  Follow-Up (approximately one month after training)

• Between group difference ratings of perceived confidence in pain assessment abilities

  Post (within 30 minutes after completion of training)

Other Outcomes (3)

• Between group difference in use of evidence-based pain assessment and management strategies as indicated on a researcher-generated questionnaire and in focus groups

  Follow-Up (approximately one month after training)

• Within intervention group change from baseline in use of evidence-based pain assessment and management strategies as indicated on a researcher-generated questionnaire

  Baseline (within 30 minutes prior to start of training), Follow-Up (approximately one month after training)

• Within intervention group descriptive ratings of training

  Post (within 30 minutes after completion of training)

Study Arms (2)

Let's Talk About Pain Training

EXPERIMENTAL

Participants complete pre-, post- and follow-up measures, and receive a pain training program. The pain assessment and management training will be based on a training previously developed and piloted by Genik et al. (2017). The training will be facilitated by the same researcher (L.G.) throughout the study.

Other: Let's Talk About Pain Training

Family Centered Care Training

SHAM COMPARATOR

Participants complete all of the same measures as those in the intervention, but receive a training about family centered care. This training will be facilitated by Andrea Cross (PhD Candidate) from CanChild and will be related to the F-words of childhood disability (function, family, fitness, fun, friends, future; Rosenbaum \& Gorter, 2012) .

Other: Family Centered Care Training

Interventions

Let's Talk About Pain Training OTHER

See arm/group descriptions.

Let's Talk About Pain Training

Family Centered Care Training OTHER

See arm/group descriptions.

Family Centered Care Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 18
• Proficient in the English language
• Active respite worker who provides respite care to children (age 0 - 18) with developmental disabilities

You may not qualify if:

• n/a

Sponsors & Collaborators

• University of Guelph: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Society of Pediatric Psychology: collaborator
• Western University: collaborator

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G2W1, Canada

Location

Related Publications (7)

• Dubois A, Capdevila X, Bringuier S, Pry R. Pain expression in children with an intellectual disability. Eur J Pain. 2010 Jul;14(6):654-60. doi: 10.1016/j.ejpain.2009.10.013. Epub 2009 Dec 5.

  PMID: 19963417 BACKGROUND

• Twycross A, Williams A. Establishing the validity and reliability of a pediatric pain knowledge and attitudes questionnaire. Pain Manag Nurs. 2013 Sep;14(3):e47-53. doi: 10.1016/j.pmn.2011.03.001. Epub 2011 Apr 17.

  PMID: 23972870 BACKGROUND

• Chen-Lim ML, Zarnowsky C, Green R, Shaffer S, Holtzer B, Ely E. Optimizing the assessment of pain in children who are cognitively impaired through the quality improvement process. J Pediatr Nurs. 2012 Dec;27(6):750-9. doi: 10.1016/j.pedn.2012.03.023. Epub 2012 Apr 10.

  PMID: 22497741 BACKGROUND

• Genik LM, McMurtry CM, Breau LM. Caring for children with intellectual disabilities part 1: Experience with the population, pain-related beliefs, and care decisions. Res Dev Disabil. 2017 Mar;62:197-208. doi: 10.1016/j.ridd.2017.01.020. Epub 2017 Feb 14.

  PMID: 28208103 BACKGROUND

• Genik LM, McMurtry CM, Breau LM, Lewis SP, Freedman-Kalchman T. Pain in Children With Developmental Disabilities: Development and Preliminary Effectiveness of a Pain Training Workshop for Respite Workers. Clin J Pain. 2018 May;34(5):428-437. doi: 10.1097/AJP.0000000000000554.

  PMID: 28877138 BACKGROUND

• Breau LM, MacLaren J, McGrath PJ, Camfield CS, Finley GA. Caregivers' beliefs regarding pain in children with cognitive impairment: relation between pain sensation and reaction increases with severity of impairment. Clin J Pain. 2003 Nov-Dec;19(6):335-44. doi: 10.1097/00002508-200311000-00001.

  PMID: 14600533 BACKGROUND

• Genik LM, McMurtry CM, Barata PC, Barney CC, Lewis SP. Study protocol for a multi-centre parallel two-group randomized controlled trial evaluating the effectiveness and impact of a pain assessment and management program for respite workers supporting children with disabilities. Paediatr Neonatal Pain. 2020 Apr 26;2(1):7-13. doi: 10.1002/pne2.12014. eCollection 2020 Mar.

  PMID: 35547857 DERIVED

MeSH Terms

Conditions

Pain; Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Organizations will not be made explicitly aware of whether they have been allocated as part of the control or experimental conditions. Organizations will be told, however, that if they are not assigned to the experimental group, they will be given the option to also have an additional training about pain in children with DD at the end of the study. They will also know about the topics of both training programs and the purpose of the study. Participants will only be told that the purpose of the study is to learn about the impact that training programs can have on respite workers' knowledge about caring for children with DD. However, given some of the information in the consent form (e.g., study title is "Let's Talk about Pain"), it is likely that the treatment condition is clear to participants.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a multi-centre clustered parallel RCT with an intervention group (pain training) and control group (control training about family centered care, with an option to receive pain training after follow-up).

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: February 5, 2018
• Study Start: May 8, 2017
• Primary Completion: July 3, 2018
• Study Completion: August 2, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)