- Forty-four
patients with difficulty sleeping, defined as taking at least 30 minutes
to settle or waking during the night requiring parental contact to fall
back to sleep, were randomized in a single-blinded, controlled trial
to attempt either total ignoring of all crying, graduated ignoring of
crying, or a “waitlist” condition in which the parents continued methods
they had previously attempted without success.
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Waitlist and treatment groups had similar characteristics at the onset.
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Primary outcome measures after one, two, three, and six weeks included
number of “good bedtimes,” or nights that took less than ten minutes
for the child to settle; and “good nighttimes,” or nights in which the
child slept by himself without waking for the whole night.
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Secondary outcomes were maternal stress, parent-child dysfunctional
interactions, child behavior, maternal depression, and parent distress.
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Analysis was not on an intention to treat basis.
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Because of lack of intention to treat analysis, the subpopulation studied
actually contained only parents who were willing to allow their children
to cry themselves to sleep.
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In this subpopulation, there was a valid, moderate-to-large effect,
on both the number of good bedtimes per week and the number of good
nights per week.
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There were no adverse effects on any secondary outcomes in the subpopulation
studied.
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