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Completed

NCT Number: NCT03421795

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

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.

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Key information

Conditions

Pain Developmental Disabilities Mental Disorders Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Guelph

Guelph, Ontario, N1G2W1, Canada

About this study

Background Information: Everyday pain is common in children with intellectual/developmental disabilities (I/DD). Inadequately managed pain in this population is a common problem, and this is likely due to these children's inability to communicate pain effectively. Unfortunately, many of these children are unable to accurately self-report or effectively communicate the pain experience. Thus, caregivers are often responsible for assessing their pain. Research has focused on professionals and parents, but it is also common for children with I/DD to receive care from others including respite workers. The investigators recently found a difference between pain beliefs held by respite workers and individuals with little to no experience with this population. Specifically, respite workers believed that a significantly larger percentage of children with severe I/DD sensed less pain than typically developing children. This is contrary to research suggesting that children with I/DD have similar pain perception but communicate it differently (e.g., through idiosyncratic behaviours). Thus, it is possible that respite workers miss critical cues when children with I/DD are in pain. As such, the investigators have developed and successfully piloted a pain training program targeted to respite workers who support children with I/DD. This program demonstrated initial success in improving respite workers' pain-related knowledge, as well as their perceptions of the feasibility of and their own confidence and skill in pain assessment and management with this population of children.

Within a randomized control trial, the objectives of this study are to further test the effectiveness of the Let's Talk About Pain respite worker training program on respite workers' (a) pain-related knowledge, (b) self-rated perceptions of the feasibility of and their own confidence and skill in pain assessment and management, and (c) use of pain assessment and management strategies specific to children with I/DD in respite settings. Participants will complete questionnaires immediately before and after provision of a pain training (or control training). Approximately one month after the training, participants will complete these questionnaires for a third time and participate in a focus group regarding their pain assessment and management strategy use.

The long term objectives of this line of research are to: 1) increase pain assessment and management abilities of respite workers, and, consequently, 2) decrease levels of suffering and ill-managed pain in children with I/DD.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • n/a

Treatment and study plan

Let's Talk About Pain Training

Other

See arm/group descriptions.

Family Centered Care Training

Other

See arm/group descriptions.

Primary outcomes

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

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

    Pain-related knowledge assessment

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

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

    Pain-related knowledge assessment

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

    Time frame: Post (within 30 minutes after completion of training)

    Pain-related knowledge assessment

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

    Time frame: Follow-Up (approximately one month after training)

    Pain-related knowledge assessment

Secondary outcomes

  1. Between group difference in ratings of the feasibility of pain assessment

    Time frame: Post (within 30 minutes after completion of training)

    Researcher generated scale measuring participants' perceptions of the feasibility of pain assessment; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  2. Between group difference in ratings of the feasibility of pain assessment

    Time frame: Follow-Up (approximately one month after training)

    Researcher generated scale measuring participants' perceptions of the feasibility of pain assessment; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  3. Between group difference ratings of the feasibility of pain management

    Time frame: Post (within 30 minutes after completion of training)

    Researcher generated scale measuring participants' perceptions of the feasibility of pain management; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  4. Between group difference ratings of the feasibility of pain management

    Time frame: Follow-Up (approximately one month after training)

    Researcher generated scale measuring participants' perceptions of the feasibility of pain management; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  5. Between group difference ratings of perceived confidence in pain assessment abilities

    Time frame: Post (within 30 minutes after completion of training)

    Researcher generated scale measuring participants' perceptions of their own confidence in their pain assessment abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  6. Between group difference ratings of perceived confidence in pain assessment abilities

    Time frame: Follow-Up (approximately one month after training)

    Researcher generated scale measuring participants' perceptions of their own confidence in their pain assessment abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  7. Between group difference ratings of perceived confidence in pain management abilities

    Time frame: Post (within 30 minutes after completion of training)

    Researcher generated scale measuring participants' perceptions of their own confidence in their pain management abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  8. Between group difference ratings of perceived confidence in pain management abilities

    Time frame: Follow-Up (approximately one month after training)

    Researcher generated scale measuring participants' perceptions of their own confidence in their pain management abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  9. Between group difference ratings of perceived skill in pain assessment

    Time frame: Post (within 30 minutes after completion of training)

    Researcher generated scale measuring participants' perceptions of their own skill in pain assessment; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  10. Between group difference ratings of perceived skill in pain assessment

    Time frame: Follow-Up (approximately one month after training)

    Researcher generated scale measuring participants' perceptions of their own skill in pain assessment; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  11. Between group difference ratings of perceived skill in pain management

    Time frame: Post (within 30 minutes after completion of training)

    Researcher generated scale measuring participants' perceptions of their own skill in pain management; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  12. Between group difference ratings of perceived skill in pain management

    Time frame: Follow-Up (approximately one month after training)

    Researcher generated scale measuring participants' perceptions of their own skill in pain management; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  13. Within intervention group change from baseline in ratings of the feasibility of pain assessment

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

    Researcher generated scale measuring participants' perceptions of the feasibility of pain assessment; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  14. Within intervention group change from baseline in ratings of the feasibility of pain management

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

    Researcher generated scale measuring participants' perceptions of the feasibility of pain management; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  15. Within intervention group change from baseline in ratings of perceived confidence in pain assessment

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

    Researcher generated scale measuring participants' perceptions of their own confidence in their pain assessment abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  16. Within intervention group change from baseline in ratings of perceived confidence in pain management

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

    Researcher generated scale measuring participants' perceptions of their own confidence in their pain management abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  17. Within intervention group change from baseline in ratings of perceived skill in pain assessment

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

    Researcher generated scale measuring participants' perceptions of their own skill in pain assessment; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  18. Within intervention group change from baseline in ratings of perceived skill in pain management

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

    Researcher generated scale measuring participants' perceptions of their own skill in pain management; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  19. Within intervention group change (i.e., maintenance) from post in ratings of the feasibility of pain assessment

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

    Researcher generated scale measuring participants' perceptions of the feasibility of pain assessment; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  20. Within intervention group change (i.e., maintenance) from post in ratings of the feasibility of pain management

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

    Researcher generated scale measuring participants' perceptions of the feasibility of pain management; 0 (Not feasible at all) - 10 (highly/extremely feasible) Likert Scale. Higher scores are better.

  21. Within intervention group change (i.e., maintenance) from post in ratings of perceived confidence in pain assessment

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

    Researcher generated scale measuring participants' perceptions of their own confidence in their pain assessment abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  22. Within intervention group change (i.e., maintenance) from post in ratings of perceived confidence in pain management

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

    Researcher generated scale measuring participants' perceptions of their own confidence in their pain management abilities; 0 (Not confident at all) - 10 (highly/extremely confident) Likert Scale. Higher scores are better.

  23. Within intervention group change (i.e., maintenance) from post in ratings of perceived skill in pain assessment

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

    Researcher generated scale measuring participants' perceptions of their own skill in pain assessment; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

  24. Within intervention group change (i.e., maintenance) from post in ratings of perceived skill in pain management

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

    Researcher generated scale measuring participants' perceptions of their own skill in pain management; 0 (Not skilled at all) - 10 (highly/extremely skilled) Likert Scale. Higher scores are better.

Other outcomes

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

    Time frame: Follow-Up (approximately one month after training)

    Assessment of use of evidence-based pain assessment and management strategies (researcher generated questionnaire with open-ended responses and focus groups)

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

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

    Assessment of use of evidence-based pain assessment and management strategies (researcher generated questionnaire)

  3. Within intervention group descriptive ratings of training

    Time frame: Post (within 30 minutes after completion of training)

    Assessment of training program endorsement

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Society of Pediatric Psychology
  • Western University

Registry information

Official study title

Let's Talk About Pain: A Randomized Controlled Trial Testing the Effectiveness of a Pain Assessment and Management Training Program for Respite Workers Supporting Children With Intellectual and Developmental Disabilities

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2018
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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