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Behavioral Insomnia of Childhood: Impact of Parent Education

NCT03320083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2017-10-27

No results posted yet for this study

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.

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

BEHAVIORAL

Educational care derived from POSSUMS

Intervention group were offered a sleep education session on healthy practices for parent-baby sleep which included information on sleep needs, sleep hygiene, training in strategies to remove obstacles that get in the way of healthy sleep. Information were provided to guide the parent in forming an action plan based on cued care which included aligning the circadian clock with real time, removing the obstacles that get in the way of healthy sleep, physical activity, mindfulness, and relaxation techniques for mothers derived from the POSSUMS approach. However, we could not use Acceptance and Commitment Therapy, because none of the investigators had sufficient training on ACT at the time the study was conducted.

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Principal Investigators

  • Perran Boran · Marmara University medical school

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2016-09-30
Completion
2016-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03320083 on ClinicalTrials.gov