Behavioral Insomnia of Childhood: Impact of Parent Education

NCT03320083 | Completed

• 1 other identifier: 09.2015.215
• Study Type: interventional
• Target: 157
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

sleep, infants, behavioural insomnia, breastfeeding

Outcome Measures

Primary Outcomes (1)

• Rates of infant sleep problems

  Infant sleep problems reported by the mother and according to Brief Infant Sleep Questionnaire (BISQ). It is not a scale. The variables of the questionnaire included 1) nocturnal sleep duration (between the hours of 7 pm and 7 am); 2) daytime sleep duration (between the hours of 7 am and 7 pm); 3) number of night wakenings; 4) duration of wakefulness during the night hours (10 pm to 6 am); 5) nocturnal sleep-onset time (the time when the child falls asleep for the night); 6) settling time (latency to falling asleep for the night); 7) method of falling asleep; 8) location of sleep; 9) preferred body position; 10) age of child; 11) gender of child; 12) birth order; and 13) role of the responder who completed the BISQ. If the child woke up more than 3 times per night, spent more than 1 hour in wakefulness during the night, or spent less than 9 hours in sleep (day and night), then they were considered as poor sleepers

  3 months

Secondary Outcomes (2)

• Breastfeeding rates

  3 months

• Maternal depression

  3 months

Study Arms (2)

Educational care derived from POSSUMS

ACTIVE COMPARATOR

Intervention group were offered a sleep education session using behavioral change counseling communication skills, derived from the POSSUMS approach developed by Douglas P and Whittingham K. However we could not use Acceptance and Commitment Therapy (ACT), because none of the investigators had sufficient training on ACT at the time the study was conducted.

Behavioral: Educational care derived from POSSUMS

Usual Care

NO INTERVENTION

General anticipatory guidance given

Interventions

Educational care derived from POSSUMS BEHAVIORAL

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.

Educational care derived from POSSUMS

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• premature infants, infants with acute or chronic medical condition

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Breast Feeding

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Feeding Behavior; Behavior

Study Officials

• Perran Boran

  Marmara University medical school

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 25, 2017
• Study Start: February 1, 2016
• Primary Completion: September 30, 2016
• Study Completion: October 30, 2016
• Last Updated: October 27, 2017

Record last verified: 2017-10