Parent-child Interactions, Child Developmental Health, and Health System Costs at 6 Months Corrected Age

Ages and Stages Questionnaire, 3rd edition: developmental screening instrument consists of 21 age-appropriate (1 to 66 months of age) questionnaires, with 30 items each. Assesses development in 5 domains: communication, gross motor, fine motor, problem-solving, and personal-social, each consisting of 6 items. Responses for each item receive a score of 0, 5, or 10 points. Item scores are summed for a total score with a possible range of 0 to 60 for all domains. Higher scores indicate more optimal child development. Based on empirically derived cut-offs, each domain total score is classified as (a) appropriate development, (b) monitoring zone (≥1 and < 2 standard deviations below the mean), and (c) need for referral (2 standard deviations below the mean). The ASQ-3 has strong psychometric properties, including high sensitivity (0.86) and specificity (0.85), and has been evaluated and recommended as an effective screener of global development in moderate and late preterm infants

Ages and Stages Questionnaire:Social-Emotional, 2nd edition: Screening instrument focused specifically on the social-emotional development of infants and young children, consisting of 9 age-appropriate (1 to 72 months of age) questionnaires. Scale at 18-months consists of 31 items, each receives a score of 0, 5, 10, or 15 points. Item scores are summed for a total score with a possible range of 0 to 465 (score of 105 represents 90th percentile). Lower total scores indicate more optimal social-emotional development. Based on empirically derived cut-offs, the total score is classified as (a) appropriate social-emotional development (below 65th percentile), (b) monitoring zone (between 65th percentile and referral cut-off), and (c) need for referral (above referral cut-off; around 80th percentile, depending on age interval). Test-retest reliability (0.89) and internal consistency reliability (0.84) are high, as are overall sensitivity (81%) and specificity (84%).

Extended Brief Infant Sleep Questionnaire (EBISQ): As the EBISQ is not a psychometric scale, no composite score is calculated, nor are there sub-scale. The scale contains 32 items capturing information on infant sleep patterns, sleep ecology, and caregiver perceptions; response categories include numerical (time, frequency count of night wakings), categorical (sleep location, bedtime activities) and ordinal rankings (how much of a problem is your baby's sleep? A large problem, a small problem, or no problem). No numerical values are assigned to items with ordinal or categorical answers. The EBISQ has been validated against actigraphy and daily-logs and its sensitivity in documenting expected developmental changes in infant sleep and the effects of environmental factors has been established.

Perceived Maternal Parenting Self-Efficacy Scale: A 20 item self-report measure of maternal parenting self-efficacy, scored on a 4-point Likert scale. The total score is calculated as a sum of responses to all 20 questions. Mothers can score between 20 - 80 overall, where the higher the score the higher the self-efficacy. Four subscales reflect different aspects of parenting, however; there are no cut-off scores.

Breastfeeding questionnaire: a non-pscyhometric questionnaire will evaluate breastfeeding rates with questions asking if participants are breastfeeding, frequency of breastfeeding, and if participants are not breastfeeding, we ask infant's age at weaning and why breastfeeding was stopped.

Provincial healthcare administrative databases

Provincial healthcare administrative databases

Provincial healthcare administrative databases

This data will be collected in two ways: 1) maternal self-report as part of a study questionnaire, and 2) from the patient chart as collected by Alberta Health Services (AHS), the provincial healthcare provider in Alberta, Canada. A data disclosure agreement has been executed such that AHS Analysts with the Analytics, Data Integration, Measurement \& Reporting (DIMR) team will link FICare data with fields related to the number antibiotic prescriptions in AHS data holdings. The specific variables related to this outcome will be selected for and identified in consultation with AHS Analysts who have extensive knowledge of their metadata.

Provincial healthcare administrative databases

Parenting Stress Index - Short Form - 4th edition (PSI-SF-4): A 36-item scale, captures general parenting stress and three subscales of Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Responses 1, 2, 3, 7, 8, 9 and 11 are summed for Defensive Responding. Subscale scores are calculated by summing response items 1-12 for Parental Distress, items 13 - 24 for Parent-Child Dysfunctional Interaction, and items 25 - 36 for Difficult Child. Total Stress score is calculated by summing the raw scores of the subscales. Raw scores are converted to T scores and percentiles. Normal range for scores is within the 16th to 84th percentiles. Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.

State-Trait Anxiety Inventory (STAI): Two sub-scales: 1) long-standing quality of trait anxiety (20 items), and 2) the temporary condition of state anxiety (20 items). Items are rated on a 4-point scale. Item scores are added to obtain subtest total scores. Scoring is reversed for anxiety-absent items (19/40 items). Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the state anxiety scale. Normative values are available in the manual. Trait anxiety was collected previously in the FICare cRCT (NCT02879799) therefore, only state anxiety will be collected at 6 months.

Edinburgh Postnatal Risk Depression (EPDS) scale: A 10 item, 4-point Likert scale, self-report measure of postnatal depression. The total score is calculated as a sum of responses to all 10 questions. Questions 1, 2 and 4 are reverse scored. The range of possible scores are: 1) 0-9; indicates presence of some symptoms of distress that may be short-lived and less likely to interfere with day to day ability to function, 2) 10 - 12; indicate presence of symptoms of distress that may be discomforting, and 3) 13+; requires further assessment and appropriate management as likelihood of depression is high. Referral to professional supports may be necessary. Any woman scoring 1+ on item 10 requires further evaluation to ensure her own safety and that of her baby/babies.