Kashikar‐Zuck 2005.
Methods |
Study design: randomised controlled trial Study grouping: cross‐over Setting: outpatient clinic Outcome measures: Children’s Depression Inventory (CDI); Pain severity visual analogue scale (VAS) completed at baseline, post‐intervention (8 weeks) and 16 weeks |
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Participants |
Type of chronic illness: juvenile primary fibromyalgia syndrome Inclusion criteria: Aged 13‐17 years, diagnosed with juvenile primary fibromyalgia; stabilised on medication for at least 4 weeks prior to enrolment; average pain level of at least 3 (mild pain) over the preceding 2 weeks on a 10 cm visual analogue scale; functional disability score greater than 7 (mild disability) on the Functional Disability Inventory Exclusion criteria: existing comorbid rheumatic disease; documented developmental delay, or impairment; major depressive disorder Baseline characteristics Overall Number: 30 Sex (males (%)): 0 (0%) Age in years (SD): mean 15.38 (1.26) Severity of chronic illness: average pain rating (VAS) of 5.30 or more (moderate) Ethnicities: 28 (93%) Caucasian, 2 (7%) African‐American Depressive symptoms – rating (SD): not reported Coping Skills Training Number: 15 Sex (males (%)): 0 (0%) Age in years (SD): not reported Severity of chronic illness: average pain rating (VAS) of 5.71/10 Ethnicities: not reported Depressive symptoms – rating (SD): mean CDI T score = 56.07 (12.42) Depressive symptoms ‐ category (none/subthreshold/clinical range/unsure): subthreshold Self‐monitoring Number: 15 Sex (males (%)): 0 (0%) Age in years (SD): not reported Severity of chronic illness: average pain rating (VAS) of 5.30/10 Ethnicities: not reported Depressive symptoms – rating (SD): mean CDI T score = 48.46 (12.89) Depressive symptoms ‐ category (none/subthreshold/clinical range/unsure): subthreshold Anxiety symptoms ‐ rating (SD): not reported Baseline differences: no significant differences |
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Interventions |
Intervention characteristics Coping skills training Audience: child and parent Description of intervention: psychoeducation, relaxation strategies; distraction and activity pacing techniques; cognitive techniques to deal with negative thoughts and mood difficulties; problem‐solving to anticipate and plan for difficult or stressful situations and improve sleep hygiene Modality: child, with parent involved in 3 sessions Dose: 6 weekly 60 minutes sessions and 2 telephone follow‐ups toward the end of 8 weeks Manualised or non‐manualised: manualised Parent or caregiver involvement: parents involved in 3 sessions Therapist involvement: delivered sessions Self‐monitoring Audience: child Description of intervention: self‐monitoring using weekly diaries for 8 weeks Modality: individual Dose: no contact, diaries provided, and outcome measures collected at 4 and 8 weeks Manualised or non‐manualised: non‐manualised Parent or caregiver involvement: no involvement Therapist involvement: no involvement |
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Outcomes |
Specific depression measures: Children’s Depression Inventory (CDI) Improvement in function: Functional Disability Inventory (FDI) Status of long‐term physical condition: Pain rating Visual Analogue Scale (VAS) |
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Identification |
Sponsorship source: Cincinnati Children’s Hospital Research Foundation, National Institutes of Health Country: USA Authors name: Susmita Kashikar‐Zuck Institution: Cincinnati Children’s Hospital Medical Center Email: Susmita.Kashikar‐Zuck@cchmc.org Address: Psychology Division, MLC 3015Cincinnati Children’s Hospital Medical CenterCincinnati, OH 45229. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Judgement comment: random allocation using a computer generated pseudo random number table and block allocation |
Allocation concealment (selection bias) | Low risk | Judgement comment: sealed envelope opened by blinded researcher |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Judgement comment: unclear about participants. Research assistants were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: rheumatologists and occupational therapists conducting 'tender point' examinations blinded to group. All other outcome measures self‐report |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: few dropouts from either group, management of missing data using ITT with last available value carried forward for missing data |
Selective reporting (reporting bias) | Low risk | Judgement comment: all planned outcomes reported |
Other bias | Low risk | Judgement comment: no other sources of bias evident |