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Assessing the effectiveness of the Feeling Better ASD pain management program for autistic children

Evaluation of the Feeling Better ASD pain management pain management programme for autistic children: a pilot and feasibility study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14141994
Enrollment
40
Registered
2024-11-11
Start date
2024-10-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic or recurrent pain in children aged 5-17 years with autism spectrum disorder Signs and Symptoms

Interventions

Participants will be asked to complete a consent form. After consent is provided participants will be assigned at random by the researchers to one of the two groups: the Internet Intervention Conditio

Sponsors

Ollscoil na Gaillimhe – University of Galway
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged between 5-17 years with a diagnosis of Autism Spectrum Disorder (ASD) with or without co-occurring intellectual disability 2. Experience chronic or recurrent pain for a period of 3 months as defined by the International Association for the Study of Pain (IASP, 2019) 3. Sufficient command of English to complete the programme and outcome measures 4. Able to provide consent/assent 5. Access to a computer/iPad with an internet connection

Exclusion criteria

Exclusion criteria: 1. People with sensory impairment that would prevent participation

Design outcomes

Primary

MeasureTime frame
1. Pain communication (frequency) measured using structured questions at baseline and post-intervention (13 weeks) 2. Pain-coping strategies (frequency) measured using the PedsQL Coping Skills Inventory at baseline and post-intervention (13 weeks) The primary feasibility outcome measures for this study are: 1. Recruitment and retention rates measured from the programme database post-intervention 2. Treatment engagement: the number of missions completed, the number of times participants logged in, the average length of time participants logged in, the number of times individual pages were viewed, the number of interactive activities completed, the number of participants who completed the daily pain diary, the most and least accessed programme components based on the mission page accessed and completion rates measured from the programme database post-intervention 3. Programme satisfaction measured at post-test using open-ended programme-specific questions referring to theme, navigation, intensity, interactive features, ease of use and level of researcher contact. Also, participants are asked to rate experience satisfaction on a 5- 5-point Likert scale ranging from 0 (not at all) to 4 (very) at post-test. 4. Treatment expectancy measured using a 5-point Likert scale at baseline and post-intervention 5. Treatment acceptability and satisfaction measured using the Internet Evaluation and Utility Questionnaire at post-test

Secondary

MeasureTime frame
1. Clinical outcomes measured at baseline and post-intervention: 1.1. Pain intensity measured using a visual analogue scale (VAS) at baseline and post-intervention (13 weeks). Parents respond to four questions. The child completes one self-report question at baseline and post-intervention (13 weeks) 1.2. Pain interference with daily living measured using the Child Activity Limitations Interview-21 (parent version) at baseline and post-intervention (13 weeks) 1.3. Overall well-being measured using the PedsQL General Well-Being Inventory (parent version) at baseline and post-intervention (13 weeks) 1.4. Parental protectiveness measured using the Adult Responses to Children's Symptoms ARCS, protect sub-scale at baseline and post-intervention (13 weeks) 1.5. Pain catastrophizing measured using the Pain Catastrophizing Scale (parent version) at baseline and post-intervention (13 weeks) 2. Adverse events measured through five questions completed by parents at post-intervention (13 weeks), reporting on any adverse events across the study period 3. Parents' and participants' beliefs about the overall/global efficacy of the intervention measured using the Global Impression of Change (three questions) at baseline and post-intervention (13 weeks) 4. Programme usage data measured from the programme database post-intervention

Countries

Ireland

Contacts

Public ContactRachel Fitzpatrick
r.fitzpatrick7@universityofgalway.ie+353 (0)91 524 411

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026