Canino 2008.

Methods	Single‐blinded randomised controlled trial comparing intervention "Take Control, Empower Yourself and Achieve Management of Asthma" (CALMA) program with control (usual care group). All study participants completed a one hour in‐home baseline interview and similar post‐interview 4 months after randomisation. Randomisation by computer algorithm based on mixed block design.
Participants	Participants were identified and screened for eligibility before invitation to participate. Inclusion criteria: families with a child aged between 5 and 12 years with poor asthma control, as defined by any of the following in the past 4 weeks: use of any asthma medication more than once a week experiencing asthma symptoms such as wheezing, tightness of chest, problems coughing, or waking up at night because of asthma either daily or continuously using the emergency department 2 or more times during the last 4 weeks; and using oral steroids or having been hospitalised in the last year Exclusion criteria: currently participating in another asthma study being the sibling of a selected child no appropriate address for follow‐up All study participants completed a one‐hour in‐home baseline interview and similar post‐interview 4 months after randomisation. Randomisation by computer algorithm based on mixed block design. Number screened: n = 332 Number eligible: n = 256 Number randomised: n = 221 (Intervention group n = 110 and Control group n = 111) 1 participant from control group and 2 participants from CALMA (intervention) group were lost to follow‐up. All analyses were based on intention‐to‐treat.
Interventions	Recruitment dates: April 2006 to October 2006 Sample size: Not stated Intervention group: CALMA is the abbreviation of the Spanish for "Take Control, Empower Yourself and Achieve Asthma Managment". The intervention was developed for reducing asthma morbidity in poor Puerto Rican children (aged 5 to 12 years) with asthma. Children and families enrolled in the intervention group received 8 asthma education modules, delivered over the course of 2 home visits with telephone contact for follow‐up and reinforcement of recommended plans and assignments. The modules aimed to help the patient/family with the following goals. Understanding the chronic nature of asthma Identifying and overcoming barriers to care and to appropriate medication use Better understanding and use of the types of medications Appropriately use the healthcare system and keep follow‐up appointments Enhance the use of action plans Improve identification of asthma triggers and environmental avoidance techniques Encourage identification of onset of symptoms and early management Assume an active role in the communication with the provider Identify the stressors that may affect the psychological well being of the parent and learn when and where to look for psychological and family therapy help, and Provide a culturally competent environment in which the family feels understood and free to share cultural beliefs and practices. The modules were culturally adapted with inclusions such as common practices and myths that Puerto Rican parents have about asthma, proper use of home remedies, culturally congruent pictures, and common asthma triggers in the island, such as Sahara dust and eruptions from Caribbean volcanoes. Educational material was developed relating to coping with marital and family stress resulting from the consequences of the child's asthma, increasing parental empowerment to deal with the Puerto Rican health system and educating parents how to teach their child and others how to manage asthma. Control group: received five flyers of educational materials that contained information about: a description of control and rescue medications, when to use them and their benefit information about what asthma is common allergens and triggers and how to prevent episodes how to take care of asthma equipment common foods that may be allergenic.
Outcomes	Primary outcome Number of symptom free days in the past month and past 2 weeks at follow‐up Secondary outcome Childhood Asthma Control Test Medication use in the last 12 months as per retrospective daily self‐report Pediatric Asthma QoL (caregivers QoL measured with Junipers Pediatric Asthma QoL scale) Caregivers Asthma Knowledge Scale Family Empowerment Scale Assessments were performed at baseline and 4 months post randomisation
Notes	Lost to follow‐up at final assessment: n = 3 Funding: National Centre for Minority Health and Health Disparities and the National Institutes of Health
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Study authors state randomisation was done based on a mixed block randomisation scheme
Allocation concealment (selection bias)	Unclear risk	Randomisation by computerised algorithm based on mixed block randomisation scheme. No information provided on how allocation concealment was maintained
Blinding of participants and personnel (performance bias) All outcomes	High risk	Complete blinding was not possible after randomisation, given the nature of the intervention compared to the control group
Blinding of outcome assessment (detection bias) All outcomes	High risk	Study authors do not describe if outcome assessment was completed by study personnel who were blinded to treatment allocation, yet describe the strict training and certification of asthma counsellors
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete outcome data were measured in > 95% of participants
Selective reporting (reporting bias)	Low risk	Intention to treat analysis used
Other bias	Unclear risk	Nil