Bignall 2015.
| Methods |
Study design: randomised controlled trial Study grouping: parallel group Setting: high school Outcome measures used: State Trait Anxiety Inventory – Trait version (STAI‐T); Asthma Control Test (ACT); Pediatric Quality of Life Inventory (PEDSQL); Forced expiratory volume (FEV) completed at baseline and at post‐intervention (1 month) |
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| Participants |
Type of chronic illness: asthma Inclusion criteria: self‐report of African‐American or black ethnicity, English‐speaking, diagnosis of asthma via the school‐based health centre (SBHC) referrals and a self‐reported history of a provider‐diagnosed asthma and a raw score of 20 or less on the Asthma Control Test (ACT) Exclusion criteria: raw score greater than 20 on the Asthma Control Test, individuals who opted out of the study by calling the research team Baseline characteristics Overall Number: 30 Sex (males (%)): 8 (34%) Age in years (SD): 15.38 (2.97) Ethnicities: African‐American Anxiety symptoms ‐ rating: not reported Relaxation/breathing retraining intervention Number: 14 Sex (males (%)): 4 (33.3%) Age in years (SD): 15.52 years (1.5) Anxiety symptoms ‐ rating (SD): STAI‐T 41.62 (3.51) Anxiety symptoms ‐ category (none/subthreshold/clinical range/unsure): severe Educational intervention Number: 16 Sex (males (%)): 4 (33.3%) Age in years (SD): 15.29 (1.04) Anxiety symptoms ‐ rating (SD): STAI‐T 39.98 (3.16) Anxiety symptoms ‐ category (none/subthreshold/clinical range/unsure): severe Baseline differences: there were no significant differences at baseline |
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| Interventions |
Intervention characteristics Breathing retraining and standard asthma education programme Audience: child Description of intervention: asthma education with a set of relaxation/breathing retraining skills for improving asthma control and anxiety. Modality: individual Dose: 2 sessions of 30 minutes over one month with a follow‐up phone call Manualised or non‐manualised: manualised Parent or caregiver involvement: none Therapist involvement: session delivery and follow‐up phone call Educational intervention (TAU) Audience: child Description of intervention: standard treatment‐as‐usual asthma education focused on the pathophysiology of asthma, standard symptom management techniques, and basic principles of the mind‐body connection as it relates to asthma Modality: individual Dose: 2 sessions of 30 minutes over one month with follow‐up phone call Manualised or non‐manualised: non‐manualised Therapist involvement: session delivery and follow‐up phone call |
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| Outcomes |
Specific anxiety measures: the State Trait Anxiety Inventory (STAI) Improvement in quality of life: Pediatric Quality of Life Inventory (PEDSQL) Status of long‐term physical condition: FEV1 (forced expiratory volume); Asthma Control Test (ACT) |
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| Identification |
Sponsorship source: Community Academic Partnership institutional grant Country: USA Comments: n/a Authors name: Whitney J. Bignall (correspondence: Sian Cotton) Institution: University of Cincinnati Email: sian.cotton@uc.edu Address: Division of Integrative Medicine,Department of Family and Community Medicine, University of Cincinnati, P.O. Box 670566, Cincinnati, OH 45267‐0566 USA |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Judgement comment: randomisation process not clearly described |
| Allocation concealment (selection bias) | Unclear risk | Judgement comment: allocation concealment not clearly described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Judgement comment: blinding of participants not clearly described |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: blinding of outcome assessors not clearly described |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Judgement comment: 3 participants dropped out and it was unclear how their data was handled |
| Selective reporting (reporting bias) | Low risk | Judgement comment: all outcomes were reported |
| Other bias | High risk | Judgement comment: study carried out by developers of the intervention |