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Behavioral Insomnia of Childhood: Impact of Parent Education

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational care derived from POSSUMS
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Initiation and Maintenance Disorders focused on measuring sleep, infants, behavioural insomnia, breastfeeding

Eligibility Criteria

6 Months - 12 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Educational care derived from POSSUMS

    Usual Care

    Arm Description

    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.

    General anticipatory guidance given

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Breastfeeding rates
    Infant breastfeeding rates
    Maternal depression
    Mothers' depressive symptoms measured by Beck depression scale. The Beck depression Inventory is a 21 item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. The highest possible total score for the test is sixty three. The score between 11-16 indicates mild mood disturbance, 17-20 borderline clinical depression, 21-30 moderate depression, 31-40 severe depression, over 40 extreme depression

    Full Information

    First Posted
    October 20, 2017
    Last Updated
    October 25, 2017
    Sponsor
    Marmara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03320083
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    September 30, 2016 (Actual)
    Study Completion Date
    October 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Marmara University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Initiation and Maintenance Disorders
    Keywords
    sleep, infants, behavioural insomnia, breastfeeding

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    157 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Educational care derived from POSSUMS
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    General anticipatory guidance given
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational care derived from POSSUMS
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Rates of infant sleep problems
    Description
    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
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Breastfeeding rates
    Description
    Infant breastfeeding rates
    Time Frame
    3 months
    Title
    Maternal depression
    Description
    Mothers' depressive symptoms measured by Beck depression scale. The Beck depression Inventory is a 21 item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. The highest possible total score for the test is sixty three. The score between 11-16 indicates mild mood disturbance, 17-20 borderline clinical depression, 21-30 moderate depression, 31-40 severe depression, over 40 extreme depression
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    12 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Perran Boran
    Organizational Affiliation
    Marmara University medical school
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Behavioral Insomnia of Childhood: Impact of Parent Education

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