O'Higgins 2008.
Methods | Design: quasi‐randomised controlled trial (randomised on the basis of timing of intervention). Setting: community classes, UK. |
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Participants | Sample sizes: n = 96; intervention n = 45; control n = 51. Ages: intervention 9 weeks of age (median); control 10 weeks of age (median). Gender: intervention 45.2% male; control 48.4% male. (Mothers who provided massage were recruited from a group with depressive symptoms. |
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Interventions | Duration 1h. Frequency ideally one session per week if possible. Six session in total (medium‐term duration of intervention). Massage provider: mothers with trained professional supervision in classes (International Association of Infant Massage). |
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Outcomes | Types of outcome: Infant Characteristic Questionnaire (ICQ), Global ratings for mother‐infant interactions attachment patterns (Strange Situtaion Procedure) and distractibility. Maternal outcomes also reported: Depressive symptoms (EPDS), anxiety (SSAI), bonding scores at 1 year, a baby care questionnaire. Timing of assessment: baseline (9 to 12 weeks of infant age) 19 weeks (infant age), and one year follow‐up. |
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Notes | Funder: The Foundation for integrated Health. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote p.190 “prospective block‐controlled randomised design”. Comment: probably done. From investigator "...by block as we needed to ensure that there were sufficient mothers in the support group at any one time (with pure randomisation, we risked having only 1 person in the support "group" or having too many people. So, mothers were contacted and invited to take part in either the massage group OR the support group depending on which arm we were recruiting for at that given timepoint.” |
Allocation concealment (selection bias) | Unclear risk | No details given. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 14/45 did not complete massage group; 20/50 did not complete the support group, no statistical differences between the groups “A Chi‐square analysis was conducted to investigate differences between the massage and support group in the number of drop‐outs and the numbers who completed all measures at one year, questionnaire measures only at one year or no measures at all at one year. No significant difference was found between the groups (Pearson’s Chi square=5.4, ns).“ data obtained from study investigator. |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible due to nature of intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote p. 190 “The interactions were rated using the Global Ratings for Mother–Infant Interactions by a blinded, trained rater.” ICG was completed by mothers therefore there is a possibility of introducing bias. |