Hands and Hearts Together

BEHAVIORAL

Circle of Security Parenting

COS-P is an attachment-based, home visiting intervention intended to supporting parents in serving as "a secure base" from which their children can explore the world, and to which their children can return in times of distress (Bowlby, 1988). Such secure base parenting increases the likelihood of children's secure attachment. COS-P also targets parental responses to children's expression of their needs (e.g., crying), and is designed to help parents understand the ways in which their own (parental) dysregulated emotional, physiological, and behavioral responses to children's emotions and behaviors can limit their responsiveness to their children's attachment needs.

BEHAVIORAL

Little Talks

Little Talks is an early literacy home visiting intervention developed for low-income, racial and ethnic minority infants and toddlers, and has been tested in Early Head Start contexts (Manz et al., 2016; Manz et al. 2017). Little Talks uses book sharing to promote early literacy and has been adapted in both English and Spanish. The intervention utilizes modular treatments during home visits, teaching parents how to facilitate language interactions with their children through book sharing. Age appropriate books are given to parents to share with their children during the intervention.

Strange Situation Procedure (SSP) #1

Time frame: Baseline

Child-parent attachment for children aged 12-24 months will be assessed with Ainsworth's Strange Situation (Ainsworth et al., 1978) procedure. The 20-minute procedure consists of two infant-parent separations, and two reunions. Infant behavior is used to classify infants as secure or one of three types of insecure; continuous security scores can also be derived, and will be used in addition to classifications.

Strange Situation Procedure (SSP) #2

Time frame: Immediately post-intervention

Child-parent attachment for children aged 12-24 months will be assessed with Ainsworth's Strange Situation (Ainsworth et al., 1978) procedure. The 20-minute procedure consists of two infant-parent separations, and two reunions. Infant behavior is used to classify infants as secure or one of three types of insecure; continuous security scores can also be derived, and will be used in addition to classifications.

Strange Situation Procedure (SSP) #3

Time frame: 6-month follow up

Child-parent attachment for children aged 12-24 months will be assessed with Ainsworth's Strange Situation (Ainsworth et al., 1978) procedure. The 20-minute procedure consists of two infant-parent separations, and two reunions. Infant behavior is used to classify infants as secure or one of three types of insecure; continuous security scores can also be derived, and will be used in addition to classifications.

Macarthur Preschool Strange Situation (PACS) #1

Time frame: Baseline

Child-parent attachment for children over 24-months will be assessed with the MacArthur Preschool Strange Situation (PACS; Cassidy et al., 1992; Solomon \& George, 2016), which also classifies children as secure or one of three types of insecure; continuous security scores on a scale of 1 to 7 can also be derived, and these (standardized) scores will be used along with classifications. This procedure consists of an initial 3-minute period in which both parent and child are in the toy-filled playroom, followed by two separations (3 and 5 minute) and two 3-minute reunions.

Macarthur Preschool Strange Situation (PACS) #2

Time frame: Immediately post-intervention

Child-parent attachment for children over 24-months will be assessed with the MacArthur Preschool Strange Situation (PACS; Cassidy et al., 1992; Solomon \& George, 2016), which also classifies children as secure or one of three types of insecure; continuous security scores on a scale of 1 to 7 can also be derived, and these (standardized) scores will be used along with classifications. This procedure consists of an initial 3-minute period in which both parent and child are in the toy-filled playroom, followed by two separations (3 and 5 minute) and two 3-minute reunions.

Macarthur Preschool Strange Situation (PACS) #3

Time frame: 6-month follow up

Child-parent attachment for children over 24-months will be assessed with the MacArthur Preschool Strange Situation (PACS; Cassidy et al., 1992; Solomon \& George, 2016), which also classifies children as secure or one of three types of insecure; continuous security scores on a scale of 1 to 7 can also be derived, and these (standardized) scores will be used along with classifications. This procedure consists of an initial 3-minute period in which both parent and child are in the toy-filled playroom, followed by two separations (3 and 5 minute) and two 3-minute reunions.

Cortisol Stress Reactivity and Recovery #1

Time frame: Baseline

Cortisol stress reactivity and recovery will be assessed (following previous studies; e.g., Luijk et al., 2010) using the Strange Situation Procedure (SSP) as the stressor. Salivary samples will be collected (using a 125mm polymer swab) at baseline (pre-task), 10-, 20-, 30-, and 40-minutes post peak SSP stressor (i.e., end of separation 2), then frozen in tubes. Radioimmunoassay analysis will be done in duplicate, with the mean used as the final measure (in ug/dl). Labs will begin in the afternoon (between 1-4pm) to reduce potential diurnal effects. Multiple studies (e.g., Bernard \& Dozier, 2010; Thompson et al., 2015) demonstrated a lack of diurnal influence in infant cortisol studies, thus time of day will not be controlled. Cortisol may fluctuate with sleep/wake patterns and eating (Gunnar \& Herrera, 2013), so investigators will control for time of last waking and eating.

Cortisol Stress Reactivity and Recovery #2

Time frame: Immediately post-intervention

Cortisol stress reactivity and recovery will be assessed (following previous studies; e.g., Luijk et al., 2010) using the Strange Situation Procedure (SSP) as the stressor. Salivary samples will be collected (using a 125mm polymer swab) at baseline (pre-task), 10-, 20-, 30-, and 40-minutes post peak SSP stressor (i.e., end of separation 2), then frozen in tubes. Radioimmunoassay analysis will be done in duplicate, with the mean used as the final measure (in ug/dl). Labs will begin in the afternoon (between 1-4pm) to reduce potential diurnal effects. Multiple studies (e.g., Bernard \& Dozier, 2010; Thompson et al., 2015) demonstrated a lack of diurnal influence in infant cortisol studies, thus time of day will not be controlled. Cortisol may fluctuate with sleep/wake patterns and eating (Gunnar \& Herrera, 2013), so investigators will control for time of last waking and eating.

Cortisol Stress Reactivity and Recovery #3

Time frame: 6-month follow up

Cortisol stress reactivity and recovery will be assessed (following previous studies; e.g., Luijk et al., 2010) using the Strange Situation Procedure (SSP) as the stressor. Salivary samples will be collected (using a 125mm polymer swab) at baseline (pre-task), 10-, 20-, 30-, and 40-minutes post peak SSP stressor (i.e., end of separation 2), then frozen in tubes. Radioimmunoassay analysis will be done in duplicate, with the mean used as the final measure (in ug/dl). Labs will begin in the afternoon (between 1-4pm) to reduce potential diurnal effects. Multiple studies (e.g., Bernard \& Dozier, 2010; Thompson et al., 2015) demonstrated a lack of diurnal influence in infant cortisol studies, thus time of day will not be controlled. Cortisol may fluctuate with sleep/wake patterns and eating (Gunnar \& Herrera, 2013), so investigators will control for time of last waking and eating.

Child Behavior Checklist (CBCL) #1

Time frame: Baseline

Child behavior problems will are assessed with the Child Behavior Checklist (version for 1.5- to 5-year-olds; CBCL; Achenbach \& Rescorla, 2000). Parents will complete this widely used 100-item questionnaire to report their children's internalizing (36 items, e.g., "is nervous, withdrawn") and externalizing (24 items, e.g., "is restless, disobedient") behavior problems. Responses are given on a 3-point scale: (0) not true, (1). somewhat/ sometimes true, (2) very/often true). Items are summed to create subscales for internalizing and externalizing problems.

Child Behavior Checklist (CBCL) #2

Time frame: Immediately post-intervention

Child behavior problems will are assessed with the Child Behavior Checklist (version for 1.5- to 5-year-olds; CBCL; Achenbach \& Rescorla, 2000). Parents will complete this widely used 100-item questionnaire to report their children's internalizing (36 items, e.g., "is nervous, withdrawn") and externalizing (24 items, e.g., "is restless, disobedient") behavior problems. Responses are given on a 3-point scale: (0) not true, (1). somewhat/ sometimes true, (2) very/often true). Items are summed to create subscales for internalizing and externalizing problems.

Child Behavior Checklist (CBCL) #3

Time frame: 6-month follow up

Child behavior problems will are assessed with the Child Behavior Checklist (version for 1.5- to 5-year-olds; CBCL; Achenbach \& Rescorla, 2000). Parents will complete this widely used 100-item questionnaire to report their children's internalizing (36 items, e.g., "is nervous, withdrawn") and externalizing (24 items, e.g., "is restless, disobedient") behavior problems. Responses are given on a 3-point scale: (0) not true, (1). somewhat/ sometimes true, (2) very/often true). Items are summed to create subscales for internalizing and externalizing problems.

Infant-Toddler Social and Emotional Assessment (ITSEA) #1

Time frame: Baseline

Child behavior problems (from parent report) will be assessed with the ITSEA (Carter \& Briggs-Gowan, 2000; Carter et al., 2003) for children below the age of 1.5 years. The ITSEA assesses internalizing and externalizing symptoms. Parents will rate items on a scale of 0 (not true) to 2 (very true).

Infant-Toddler Social and Emotional Assessment (ITSEA) #2

Time frame: Immediately post-intervention

Child behavior problems (from parent report) will be assessed with the ITSEA (Carter \& Briggs-Gowan, 2000; Carter et al., 2003) for children below the age of 1.5 years. The ITSEA assesses internalizing and externalizing symptoms. Parents will rate items on a scale of 0 (not true) to 2 (very true).

Infant-Toddler Social and Emotional Assessment (ITSEA) #3

Time frame: 6-month follow up

Child behavior problems (from parent report) will be assessed with the ITSEA (Carter \& Briggs-Gowan, 2000; Carter et al., 2003) for children below the age of 1.5 years. The ITSEA assesses internalizing and externalizing symptoms. Parents will rate items on a scale of 0 (not true) to 2 (very true).

Parental Emotional Responses to Child Distress #1

Time frame: Baseline

Parental emotional response to child distress will be assessed with the Crying Infant Video Task (Leerkes et al., 2004, 2011), in which parents watch four one-minute videos of (gender-neutral, racially diverse) infants in distress (i.e., crying loudly and continuously while sitting in a highchair). Following each clip, parents complete a questionnaire (4-point scale; 17 items) about their emotions while watching the clips, and elaborate about these emotions. Mean intensity scores are used to create a child-oriented empathic emotional response score (e.g., child-oriented sad, sympathy) and a parent-oriented negative emotions score (e.g., parent-oriented irritated, angry; see Leerkes, 2010).

Parental Emotional Responses to Child Distress #2

Time frame: Immediately post-intervention

Parental emotional response to child distress will be assessed with the Crying Infant Video Task (Leerkes et al., 2004, 2011), in which parents watch four one-minute videos of (gender-neutral, racially diverse) infants in distress (i.e., crying loudly and continuously while sitting in a highchair). Following each clip, parents complete a questionnaire (4-point scale; 17 items) about their emotions while watching the clips, and elaborate about these emotions. Mean intensity scores are used to create a child-oriented empathic emotional response score (e.g., child-oriented sad, sympathy) and a parent-oriented negative emotions score (e.g., parent-oriented irritated, angry; see Leerkes, 2010).

Parental Emotional Responses to Child Distress #3

Time frame: 6-month follow up

Parental emotional response to child distress will be assessed with the Crying Infant Video Task (Leerkes et al., 2004, 2011), in which parents watch four one-minute videos of (gender-neutral, racially diverse) infants in distress (i.e., crying loudly and continuously while sitting in a highchair). Following each clip, parents complete a questionnaire (4-point scale; 17 items) about their emotions while watching the clips, and elaborate about these emotions. Mean intensity scores are used to create a child-oriented empathic emotional response score (e.g., child-oriented sad, sympathy) and a parent-oriented negative emotions score (e.g., parent-oriented irritated, angry; see Leerkes, 2010).

Electrodermal Activity (EDA) arousal #1

Time frame: Baseline

Parental EDA arousal in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA). For EDA investigators will attach two silver chloride electrodes to the palmar surface of the second phalanges of the index and middle fingers of each participant's non-dominant hand. EDA sample rate will be 1000 samples per second. Phasic skin conductance will be calculated using a smoothing filter with a window width of 0.25 seconds. Skin conductance responses (SCRs) will be calculated using a threshold of 0.05 µS. The EDA variable will be the sum the SCRs across the four videos.

Electrodermal Activity (EDA) arousal #2

Time frame: Immediately post-intervention

Parental EDA arousal in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA). For EDA investigators will attach two silver chloride electrodes to the palmar surface of the second phalanges of the index and middle fingers of each participant's non-dominant hand. EDA sample rate will be 1000 samples per second. Phasic skin conductance will be calculated using a smoothing filter with a window width of 0.25 seconds. Skin conductance responses (SCRs) will be calculated using a threshold of 0.05 µS. The EDA variable will be the sum the SCRs across the four videos.

Electrodermal Activity (EDA) arousal #3

Time frame: 6-month follow up

Parental EDA arousal in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA). For EDA investigators will attach two silver chloride electrodes to the palmar surface of the second phalanges of the index and middle fingers of each participant's non-dominant hand. EDA sample rate will be 1000 samples per second. Phasic skin conductance will be calculated using a smoothing filter with a window width of 0.25 seconds. Skin conductance responses (SCRs) will be calculated using a threshold of 0.05 µS. The EDA variable will be the sum the SCRs across the four videos.

Respiratory Sinus Arrhythmia (RSA) #1

Time frame: Baseline

Parental RSA change in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA) and respiratory sinus arrhythmia (RSA). For RSA, investigators will attach three electrodes in a modified Lead II placement on the distal end of the right clavicle, lower left rib cage chest, and right rib cage of each parent's chest. The ECG signal will be sampled continuously with low-pass filtering at 1000 Hertz and passed through an Analog-to-Digital converter. RSA values will be derived from the interbeat interval series and resampled at 25 msec to create a stationary wave form. The integral of the power in the RSA band (0.12 to 0.40 for parents) will be extracted to obtain the RSA statistics in 30-second epochs, and will be used to calculate RSA change in response to infant distress.

Respiratory Sinus Arrhythmia (RSA) #2

Time frame: Immediately post-intervention

Parental RSA change in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA) and respiratory sinus arrhythmia (RSA). For RSA, investigators will attach three electrodes in a modified Lead II placement on the distal end of the right clavicle, lower left rib cage chest, and right rib cage of each parent's chest. The ECG signal will be sampled continuously with low-pass filtering at 1000 Hertz and passed through an Analog-to-Digital converter. RSA values will be derived from the interbeat interval series and resampled at 25 msec to create a stationary wave form. The integral of the power in the RSA band (0.12 to 0.40 for parents) will be extracted to obtain the RSA statistics in 30-second epochs, and will be used to calculate RSA change in response to infant distress.

Respiratory Sinus Arrhythmia (RSA) #3

Time frame: 6-month follow up

Parental RSA change in response to child distress will be assessed during the Crying Infant Video Task (above). Investigators will use a MindWare BioNex 8-Slot Chassis Assembly and BioLab Acquisition Software to tap parental electrodermal activity (EDA) and respiratory sinus arrhythmia (RSA). For RSA, investigators will attach three electrodes in a modified Lead II placement on the distal end of the right clavicle, lower left rib cage chest, and right rib cage of each parent's chest. The ECG signal will be sampled continuously with low-pass filtering at 1000 Hertz and passed through an Analog-to-Digital converter. RSA values will be derived from the interbeat interval series and resampled at 25 msec to create a stationary wave form. The integral of the power in the RSA band (0.12 to 0.40 for parents) will be extracted to obtain the RSA statistics in 30-second epochs, and will be used to calculate RSA change in response to infant distress.

Coping with Toddlers' Negative Emotions Scale (CTNES) #1

Time frame: Baseline

Parental behavioral sensitivity in response to child distress will be assessed using the Coping With Toddlers' Negative Emotions Scale (CTNES; Spinrad et al., 2007), parents will report their likely behavior on a scale of 1 (very likely) to 7 (very unlikely) in response to 12 hypothetical situations with their distressed child (e.g., "If my child becomes upset and cries because he is left alone…, I would:"). For each item, parents report their likelihood of responding in six different ways, for instance punitive responses (i.e., punishing the child); minimizing responses (i.e., telling child to stop overreacting); emotion-focused reactions (i.e., comforting); and problem-focused reactions (i.e., helping child come up with solution). Following Gudmundson and Leerkes (2012), investigators will form supportive and unsupportive parental response composites.

Coping with Toddlers' Negative Emotions Scale (CTNES) #2

Time frame: Immediately post-intervention

Parental behavioral sensitivity in response to child distress will be assessed using the Coping With Toddlers' Negative Emotions Scale (CTNES; Spinrad et al., 2007), parents will report their likely behavior on a scale of 1 (very likely) to 7 (very unlikely) in response to 12 hypothetical situations with their distressed child (e.g., "If my child becomes upset and cries because he is left alone…, I would:"). For each item, parents report their likelihood of responding in six different ways, for instance punitive responses (i.e., punishing the child); minimizing responses (i.e., telling child to stop overreacting); emotion-focused reactions (i.e., comforting); and problem-focused reactions (i.e., helping child come up with solution). Following Gudmundson and Leerkes (2012), investigators will form supportive and unsupportive parental response composites.

Coping with Toddlers' Negative Emotions Scale (CTNES) #3

Time frame: 6 month follow up

Parental behavioral sensitivity in response to child distress will be assessed using the Coping With Toddlers' Negative Emotions Scale (CTNES; Spinrad et al., 2007), parents will report their likely behavior on a scale of 1 (very likely) to 7 (very unlikely) in response to 12 hypothetical situations with their distressed child (e.g., "If my child becomes upset and cries because he is left alone…, I would:"). For each item, parents report their likelihood of responding in six different ways, for instance punitive responses (i.e., punishing the child); minimizing responses (i.e., telling child to stop overreacting); emotion-focused reactions (i.e., comforting); and problem-focused reactions (i.e., helping child come up with solution). Following Gudmundson and Leerkes (2012), investigators will form supportive and unsupportive parental response composites.

Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #1

Time frame: Baseline

Raters will observe parental behavioral sensitivity during the 'Stranger Approach' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit fearfulness in children by having an adult stranger approach the child. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.

Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #1

Time frame: Baseline

Raters will observe parental behavioral sensitivity during the 'Jar' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit frustration and anger in children by placing an attractive snack (e.g. rainbow goldfish), in a plastic jar. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.

Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #2

Time frame: Immediately post-intervention

Raters will observe parental behavioral sensitivity during the 'Stranger Approach' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit fearfulness in children by having an adult stranger approach the child. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.

Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #2

Time frame: Immediately post-intervention

Raters will observe parental behavioral sensitivity during the 'Jar' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit frustration and anger in children by placing an attractive snack (e.g. rainbow goldfish), in a plastic jar. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.

Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #3

Time frame: 6-month follow up

Raters will observe parental behavioral sensitivity during the 'Stranger Approach' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit fearfulness in children by having an adult stranger approach the child. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.

Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #3

Time frame: 6-month follow up

Raters will observe parental behavioral sensitivity during the 'Jar' Lab-TAB task (Goldsmith \& Rothbart, 1999), a task designed to elicit frustration and anger in children by placing an attractive snack (e.g. rainbow goldfish), in a plastic jar. This task lasts less than 2 minutes. The first 2 minutes are coded for child temperament, with 5 minutes then coded for parental sensitivity. Given the investigators' particular focus to sensitivity to distress, investigators will retain their analytic focus on sensitivity during distress, yet collection of both will allow for additional exploratory analyses in the future. Parental sensitivity (4-point scale) will be coded following the National Institute of Child Health and and Human Development (NICHD; 1999) guidelines.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.