Clinical trial NCT03320083: Behavioral Insomnia of Childhood: Impact of Parent Education
Official title: Associates and Natural Course of Behavioral Insomnia of Childhood: Impact of Parent Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: sleep, infants, behavioural insomnia, breastfeeding
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 157
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Behavioral Insomnia of Childhood (BIC) is among the most prevalent problem presented to pediatricians with a reported occurrence of approximately 30% worldwide.The most widely applied treatment strategies for BIC in infants comprise behavioral procedures such as unmodified extinction; graduated extinction (ignoring the infant cries with minimal checks), or camping out. Unfortunately, breastfeeding is usually considered as an undesirable sleep association in these strategies. Moreover, less is known regarding the effects of these interventions on breastfeeding outcomes. The cued care is defined as a pattern of care characterized by sensible caregiver responsiveness, which meets the need underlying the infant's cues in a flexible manner. In this context, POSSUMS has been developed as a cued care sleep intervention, which is quite different from the conventional sleep training techniques. In the current study, investigators hypothesized that mothers receiving the cued care sleep intervention would report less sleep problems in their infants. Secondary outcomes included improvement in maternal mood and maintenance of the breastfeeding during the observation period.

Detailed description: Behavioral Insomnia of Childhood (BIC) is among the most prevalent problem presented to pediatricians with a reported occurrence of approximately 30% worldwide.Like all the other behavioral problems, sleep problem is defined by the the parents, and influenced by parental psychopathology, parenting styles, family dynamics, culturally-based differences in values, socio-economic factors, temperament, developmental stage and medical condition of the child. Moreover, there is also data suggesting an association of depressed mood among mothers to infants with BIC. The most widely applied treatment strategies for BIC in infants comprise behavioral procedures such as unmodified extinction; graduated extinction (ignoring the infant cries with minimal checks), or camping out. The primary outcomes of these interventions include enabling infants to learn to self soothe to sleep, having less fragmented night-time sleep and longer night-time sleep periods. Unfortunately, breastfeeding is usually considered as an undesirable sleep association in these strategies. Moreover, less is known regarding the effects of these interventions on breastfeeding outcomes. Within the infant sleep research field, not breastfed but the formula fed baby is usually considered as the biological norm. However, since nursing influences both the maternal and infant sleep architecture, the outcomes of those behavioral interventions can not be accurately evaluated without considering the breastfeeding.

The cued care is defined as a pattern of care characterized by sensible caregiver responsiveness, which meets the need underlying the infant's cues in a flexible manner. In this context, POSSUMS has been developed as a cued care sleep intervention, which is quite different from the conventional sleep training techniques. This method uses the breast to make the baby go back to sleep as quickly as possible as long as the mother is happy with breastfeeding at night.

In the current study, investigators hypothesized that mothers receiving the cued care sleep intervention would report less sleep problems in their infants. Secondary outcomes included improvement in maternal mood and maintenance of the breastfeeding during the observation period.

The first part of the study was a baseline assessment of sleep problems. Software generated random number table was used to randomly allocate subjects to intervention and usual care groups. Mother-infant dyads in both groups were reassessed 3 months post intervention.

225 consecutive mother-infant dyads were assessed for eligibility at Marmara University Medical School, well- child outpatient clinic, Istanbul between 01 February 2016 and 15 April 2016. Seven did not meet the inclusion criteria, and 35 participants declined to participate. 91 were allocated to usual care, and 92 were allocated to patient education. Twenty five participants from the usual care and 1 mother infant dyad from the intervention group were lost to follow up and 157were included in the final analysis.

Eligibility criteria: Inclusion Criteria:

* infants' gestational age ≥37 weeks, healthy with normal birth weight (≥2.5 kg),and absence of any neonatal or postnatal medical condition

Exclusion Criteria:

* premature infants, infants with acute or chronic medical condition

Primary outcomes:
measure: Rates of infant sleep problems
timeFrame: 3 months
Secondary outcomes:
measure: Breastfeeding rates
timeFrame: 3 months
measure: Maternal depression
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University medical school
name: Perran Boran
role: STUDY_CHAIR
References: