Mikami 2010

Methods	Design: Randomised controlled trial
Participants	Participants: Participants were families of 62 children (42 boys) with ADHD. A comparison group of ‘normal’ children (62 age‐ and sex‐matched children) were also recruited. Diagnoses of those with ADHD were made via Child Symptom Inventory (CSI, Gadow 1994) and diagnoses were verified in a clinical review with parents using the K‐SAD (Kaufman 1997). Majority of children with ADHD were DSM‐IV Combined Type (ADHD‐C; n = 46) and the remainder were DSM‐IV Inattentive Type (ADHD‐I; n = 16). Data on ethnicity provided for the whole sample. Most children (85%) classed as white, 5% African American, 2% Asian American, 1% Latino and 7% of more than one race. Each child participated with one parent ‘most involved in a child’s social life’, 94% of whom were female. Children on medication (n = 40) for 3 months prior to study were permitted to continue on the same regime. Age: 6‐10 years (mean = 8.26, SD = 1.21). Gender: 42 boys, 20 girls. Number: 62 (30 in intervention, 32 in control arm). Setting: Recruitment was from clinics, schools, paediatricians and from a database of families who had previously participated in research at the University of Virginia (Charlottesville, Virginia, USA). Inclusion criteria: Children with ADHD. Exclusion criteria: Pervasive developmental disorders, full scale IQ below 70 or verbal IQ below 75. Anxiety/depressive disorders, ODD and CD were permitted, although no child met criteria for CD. No child could be receiving other psychosocial treatment for social or behavioural issues; however, academic interventions were allowed.
Interventions	Parental friendship coaching (PFC) was provided in eight 90 minute group sessions, delivered once weekly, involving 5 to 6 parents and led by two clinicians. The parent who had originally completed questionnaire and attended baseline playgroup assessment was requested to attend PFC, but other parent could attend if wished. Sessions were manualised. One month after the study ended, parents were contacted by phone and interviewed regarding changes in their child’s peer relationships. Topic I: Setting a foundation for effective coaching by improving the parent‐child relationship Session 1: Building a positive parent‐child relationship by using ‘attending’ and ‘special time’; How antecedents and consequences shape behaviour Session 2: Using active listening when discussing child’s social concerns; providing effective praise and constructive feedback to your child Topic II: Coaching your child in social skills needed for good peer relationships Session 3: Teaching child good dyadic play skills Session 4: Choosing the right peer to foster a friendship with your child; Meeting new friends through unstructured and organised activities Topic III: Organising playdates that will foster the development of good friendships Session 5: Inviting a peer for a playdate; how parents can network with other parents and set a good social example Session 6: Preparing the playdate setting as the host to prevent boredom and conflict among the children Session 7: Debriefing with your child after the playdate; Preparing your child for a playdate as a guest Topic IV: Review and future directions Session 8: Recap of skills taught; reasons for backsliding; what to expect in the future Homework issued with each session involving worksheets, practice sessions, discussions with the child and setting up playdates.  Group viewing of videotapes of parental interaction was used as a teaching tool. Control group: No treatment,  but after follow‐up, control group parents were offered a workshop summarising PFC content
Outcomes	Primary outcomes: Changes in general behaviour Social Skills Rating System (SSRS): (Gresham 1990) (as assessed separately by both parent and teacher) Change in the child's ADHD‐symptom‐related behaviour in school setting Dishion Social Acceptance Scale (DSAS) (Dishion 2003) Outcome measures unable to use: Quality of Play Questionnaire (QPQ) (Frankel 2003) (questionnaire only available on an unpublished manuscript) Child friendships at follow‐up (global 5 point questionnaire completed by parent) Parental Behaviour in Playgroup (socialising, facilitation and corrective feedback) (videotapes coded by blinded observers on a scale of 10) Parental Behaviour in Parent‐child interaction (coded as above using a Likert scale from 0 to 3) Playdates Hosted
Notes	Funding from NIMH grant
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomly assigned to receive PFC or to be in a no‐treatment control group".  Method of randomisation not described. It is clear that six cohorts were randomised in a stratified manner, each cohort containing five to six playgroups. Each playgroup contained one parent receiving PFC, one parent receiving no treatment, and two other parents of children without ADHD, who received no intervention.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding (performance bias and detection bias) of participants?	High risk	Participants cannot be blinded to intervention.
Blinding (performance bias and detection bias) of those delivering intervention?	High risk	Those delivering intervention cannot be blinded.
Blinding (performance bias and detection bias) of outcome assessors?	Low risk	Blinding of outcome assessors was mentioned for those assessing videotaped interactions. Blinding is not mentioned for other outcomes, but it seems likely that this was attended to given the rigour relating to the videotaped outcomes. Also, "although parents were obviously aware of whether or not they had received PFC, study personnel kept teachers unaware of the family's treatment status and asked parents to not give teachers this information" (page 740) (Enders 2001).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Investigators described using intention‐to‐treat analysis for missing data (p. 744) using "full information maximum likelihood methods".
Selective reporting (reporting bias)	Unclear risk	All likely outcomes appear to be reported but in the absence of the trial's protocol judgement must remain 'unclear'.
Other bias	Low risk	In one cohort, a parent of a child with ADHD (chosen randomly) was assigned to treatment. Steps were however taken to test no demographic differences existed at baseline between the two ADHD groups.