Methods |
Design: three group parallel trial
Purpose: examine the effect of an office based intervention to maintain parent‐adolescent teamwork in diabetes management |
Participants |
Patients: families with a young person with type 1 diabetes
Baseline comparability: yes (age, gender, HbA1c, etc) |
Interventions |
Placebo: over six months four 20 to 30 minute sessions with 'traditional' diabetic education with no focus on parental involvement
Untreated: no sessions
Experimental: sessions of parental‐adolescent teamwork therapy
(Co‐intervention: standard diabetic care) |
Outcomes |
Insulin routine score for parental involvement (4 point Likert scale)
HbA1c (%)
Blood glucose monitoring score
Diabetes family conflict scale
Diabetic family behavior checklist |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
NS |
Allocation concealment? |
Unclear risk |
NS |
Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/teamwork intervention) |
Blinding?
Outcome assessor |
Unclear risk |
NS |
Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop out < 15 % |
Free of selective reporting? |
Unclear risk |
No protocol available |
Free of other bias? |
Low risk |
|
No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
Trial size > 49? |
Low risk |
N = 57 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Not clearly concealed allocation |