Field 1996.
Methods | Design: quasi‐randomised controlled trial. Setting: community (daycare ‐ nursery school), USA. |
|
Participants | 40 full‐term 1 ‐ 3 month old infants, recruited if their adolescent mothers were diagnosed as depressed following delivery. n = 20 massage; n = 20 control. | |
Interventions | Infants in the intervention group received massage by a researcher (complete face and body using mineral baby oil); the control group infants were rocked (by cradling in the arms of the researcher). Massage delivered for 15 mins a day 2 days a week over 6 weeks. Massage provider: researchers. |
|
Outcomes | 1.Sleep/wake behaviours (Thoman 1981). 2.Salivary cortisol (ng/mL). 3.Weight (lb) and formula intake (volume, no units given, assumed US fl. oz). 4.Temperament ratings ‐ using Colorado Child Temperament Scale. | |
Notes | NIMH grants and Johnson and Johnson, Gerber Foundation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quasi‐randomised, but no additional details of how infants were selected were provided. |
Allocation concealment (selection bias) | Unclear risk | Unclear, no details given. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropout for 40 post‐natally depressed mother‐infant dyads because the infants were being cared for by teachers in a nursery school during the six‐week study (medium‐term duration of intervention). |
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. Researchers carried out the massage. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Teachers and mother who recorded outcomes were unaware of therapy (mothers) or intent of study (teachers). Comment some attempt at blinding was made although it is implied that teacher knew which therapy was delivered. |