Hands and Hearts Together

• Sponsor: University of Maryland, College Park (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05834907
• Collaborator: Lehigh University (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 249
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 51.1
• Patients Per Site: 124.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

Growing evidence demonstrates that secure attachment in childhood predicts children's healthy social, biological, and behavioral functioning, whereas insecure attachment predicts behavior problems and physiological dysregulation; thus, efforts to foster secure attachment are crucial for promoting the healthy development of children and families. This proposal describes a randomized controlled trial (RCT) of an innovative intervention program that can be widely implemented designed to foster children's secure attachment, promote healthy physiological regulation, and reduce the risk for behavior problems: The Circle of Security ® Parenting (COS-P) intervention. To this end, investigators will conduct an RCT with 249 parent-child dyads enrolled in two diverse Early Head Start (EHS) programs.

Condition or Disease	Intervention/Treatment	Phase
Parent-Child Relations; Development, Infant; Parenting; Development, Child	Behavioral: Circle of Security Parenting; Behavioral: Little Talks	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 249 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Prevention of Attachment Insecurity, Physiological Dysregulation, and Child Behavior Problems
• Actual Study Start Date: Mar 27, 2023
• Anticipated Primary Completion Date: Jun 30, 2027
• Anticipated Study Completion Date: Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Circle of Security Parenting (COS-P) These participants will receive the Circle of Security Parenting (COS-P) intervention, an attachment-based, manualized, 8-session (90 minutes/session), home visiting intervention.	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.
Active Comparator: Little Talks These participants will receive the Little Talks intervention, a manualized, 8-session (90 minutes/session) early literacy home visiting intervention.	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.

Outcome Measures

Primary Outcome Measures

1. Strange Situation Procedure (SSP) #1 [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.

2. Strange Situation Procedure (SSP) #2 [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.

3. Strange Situation Procedure (SSP) #3 [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.

4. Macarthur Preschool Strange Situation (PACS) #1 [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.

5. Macarthur Preschool Strange Situation (PACS) #2 [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.

6. Macarthur Preschool Strange Situation (PACS) #3 [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.

7. Cortisol Stress Reactivity and Recovery #1 [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.

8. Cortisol Stress Reactivity and Recovery #2 [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.

9. Cortisol Stress Reactivity and Recovery #3 [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.

10. Child Behavior Checklist (CBCL) #1 [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.

11. Child Behavior Checklist (CBCL) #2 [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.

12. Child Behavior Checklist (CBCL) #3 [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.

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

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

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

16. Parental Emotional Responses to Child Distress #1 [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).

17. Parental Emotional Responses to Child Distress #2 [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).

18. Parental Emotional Responses to Child Distress #3 [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).

19. Electrodermal Activity (EDA) arousal #1 [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.

20. Electrodermal Activity (EDA) arousal #2 [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.

21. Electrodermal Activity (EDA) arousal #3 [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.

22. Respiratory Sinus Arrhythmia (RSA) #1 [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.

23. Respiratory Sinus Arrhythmia (RSA) #2 [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.

24. Respiratory Sinus Arrhythmia (RSA) #3 [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.

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

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

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

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

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

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

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

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

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

Secondary Outcome Measures

1. Financial Stress Questionnaire #1 [Baseline]

   The Financial Stress Questionnaire is a 9-item instrument, developed by the Fast Track project (CPPRG, 1994), which explores sources of household spending and adequacy of funds for paying bills. The questionnaire is administered to parents. The parent is asked to evaluate the affordability of 7 spending sources in the household (home, clothing, furniture, car, food, medical care and leisure) on a 1 to 5 scale (strongly agree, agree, neutral, disagree, strongly disagree); how much difficulty he/she had to pay the bills on a 1 to 5 scale (a great of difficulty to no difficulty at all) and how much money was left at the end of the month on a 1 to 4 scale (not enough, just enough, some money left, more than enough money left over).

2. Financial Stress Questionnaire #2 [Immediately post-intervention]

   The Financial Stress Questionnaire is a 9-item instrument, developed by the Fast Track project (CPPRG, 1994), which explores sources of household spending and adequacy of funds for paying bills. The questionnaire is administered to parents. The parent is asked to evaluate the affordability of 7 spending sources in the household (home, clothing, furniture, car, food, medical care and leisure) on a 1 to 5 scale (strongly agree, agree, neutral, disagree, strongly disagree); how much difficulty he/she had to pay the bills on a 1 to 5 scale (a great of difficulty to no difficulty at all) and how much money was left at the end of the month on a 1 to 4 scale (not enough, just enough, some money left, more than enough money left over).

3. Financial Stress Questionnaire #3 [6-month follow-up]

   The Financial Stress Questionnaire is a 9-item instrument, developed by the Fast Track project (CPPRG, 1994), which explores sources of household spending and adequacy of funds for paying bills. The questionnaire is administered to parents. The parent is asked to evaluate the affordability of 7 spending sources in the household (home, clothing, furniture, car, food, medical care and leisure) on a 1 to 5 scale (strongly agree, agree, neutral, disagree, strongly disagree); how much difficulty he/she had to pay the bills on a 1 to 5 scale (a great of difficulty to no difficulty at all) and how much money was left at the end of the month on a 1 to 4 scale (not enough, just enough, some money left, more than enough money left over).

4. O'Leary-Porter Overt Hostility Scale [Baseline]

   Marital Stress will be assessed using the 10-item O'Leary-Porter Overt Hostility Scale, which measures how often parents openly argue, display physical and verbal hostility, and criticize each other in the presence of the children (Johnson & O'Leary, 1987; Porter & O'Leary, 1980). The scale uses a 6-point scale from 1 = never to 6 = very often. Investigators made slight modifications to this scale to reduce the focus on only marital relationships. Participants under 20 years of age will receive a 9-item version of this scale to avoid asking younger participants about experiences of witnessing physical violence.

5. Adverse Childhood Experiences Questionnaire (ACE-Q) [Baseline]

   The Adverse Childhood Experience Questionnaire (ACE-Q; Felitti et al., 1998) is a brief rating scale that measures the number of adverse childhood experiences that occurred in the first 18 years of life. The ACE-Q has 9 yes/no items that count the number of adverse childhood experiences participants experienced in the first 18 years of their life. A sample item is "Did a parent or other adult in the household often swear at you, insult you, put you down, or humiliate you? OR act in a way that made you afraid that you might be physically hurt?" Participants indicate yes or no for each question, and if the answer is yes, then a score of 1 is entered for that item. The number of ACEs is the total number of questions for which the answer was yes. To avoid asking younger participants about experiences of physical or sexual abuse, this questionnaire will only be given to participants over 20 years of age.

6. Role Overload [Baseline]

   Following the recommendations of Thiagarajan et al. (2006), Reilly's (1982) 13-item Role Overload Scale will be adapted into a 6-item unidimensional scale assessing parents' feelings of being overwhelmed with parenting duties, juggling multiple obligations, and lacking time to rest or pursue desired activities (e.g., "I cannot ever seem to catch up"). Parents' scores indicating how often they agree with the corresponding statements, using a 7-point scale which ranges from 1 = Never to 7 = Always, will be averaged.

7. My Exposure to Violence [Baseline]

   Witnessing community violence and violent victimization will be assessed using two subscales (victimization and witnessing) of the My Exposure to Violence (MyETV; Selner-O'Hagan et al., 1998). This is a 25-item instrument that was designed to measure participants' exposure to violence in the past year. The MyETV asks participants about witnessed as well as personally experienced violence, yielding three subscales (of which investigators will use two). The three subscales are witnessing violence, violent victimization, and total exposure. Frequency of exposure is measured on a 4-point scale (once, 2 or 3 times, 4 to 10 times, more than 10 times). To avoid asking questions about childhood physical or sexual abuse, this questionnaire will only be given to participants over 20 years of age.

8. Experiences in Close Relationships Scale (ECR) [Baseline]

   Adult attachment style will be assessed with the 36-item self-report Experiences in Close Relationships Scale (ECR; Brennan, Clark, & Shaver, 1998; see Mikulincer & Shaver, 2016). The ECR assesses two dimensions of adult attachment style: attachment related avoidance (discomfort with closeness and intimacy) and attachment related anxiety (intense fear of rejection and abandonment) each on a scale of 1 (low) to 7 (high).

9. Center for Epidemiologic Studies Depression Scale (CES-D) #1 [Baseline]

   Parental depressive symptoms will be assessed with the CES-D (Radloff, 1977). This 20-item self-report measure (Radloff, 1977) taps the frequency with which respondents experienced depressive symptoms over the past week. Responses are given on a 4-point scale, with 0 indicating that the symptom was rarely or never felt, and 3 indicating that it was experienced most or all of the time.

10. Center for Epidemiologic Studies Depression Scale (CES-D) #2 [Immediately post-intervention]

    Parental depressive symptoms will be assessed with the CES-D (Radloff, 1977). This 20-item self-report measure (Radloff, 1977) taps the frequency with which respondents experienced depressive symptoms over the past week. Responses are given on a 4-point scale, with 0 indicating that the symptom was rarely or never felt, and 3 indicating that it was experienced most or all of the time.

11. Center for Epidemiologic Studies Depression Scale (CES-D) #3 [6-month follow-up]

    Parental depressive symptoms will be assessed with the CES-D (Radloff, 1977). This 20-item self-report measure (Radloff, 1977) taps the frequency with which respondents experienced depressive symptoms over the past week. Responses are given on a 4-point scale, with 0 indicating that the symptom was rarely or never felt, and 3 indicating that it was experienced most or all of the time.

12. Child Behavior Questionnaire [Baseline]

    Parents will complete the age appropriate version of the Child Behavior Questionnaires designed by Rothbart & colleagues (e.g., Putnam & Rothbart, 2006). This questionnaire assesses child temperamental reactivity and child fearful temperament.

13. Stranger Approach Lab-TAB Task to assess child temperament [Baseline]

    Raters will observe child temperament during the 'Stranger Approach' Lab-TAB task (Goldsmith & Rothbart, 1999), a task designed to elicit fearfulness by having an adult stranger approach and stare at the child in a standardized fashion. The elements of novelty and intrusiveness should elicit various degrees of fearful distress and avoidance. This task lasts approximately 1-2 minutes.

14. Behind Barrier Lab-TAB Task to assess child temperament [Baseline]

    Raters will observe child temperament during the 'Behind Barrier' Lab-TAB task (Goldsmith & Rothbart, 1999), a task designed to elicit frustration and anger by placing a toy, with which the child has been playing, behind a barrier. Anger is coded as verbal and physical action against the barrier or persons present. This task lasts approximately 3 minutes.

15. Jar Lab-TAB Task to assess child temperament [Baseline]

    Raters will observe child temperament during the 'Jar' Lab-TAB task (Goldsmith & Rothbart, 1999), a task designed to elicit frustration and anger by placing an attractive snack (e.g. rainbow goldfish), in a plastic jar. This action is representative of the type of frustration a child typically encounters when exploration or play is blocked. Anger is coded as verbal and physical action against the jar or persons present. This task lasts approximately 1-2 minutes.

16. Spider Lab-TAB Task to assess child temperament [Baseline]

    Raters will observe child temperament during the 'Spider' Lab-TAB task (Goldsmith & Rothbart, 1999), a task designed to elicit fearfulness by having a toy spider unexpectedly approach the child. The elements of novelty, uncertainty and intrusiveness, as well as a possible fear of animals, should elicit varying degrees of fear. This task lasts approximately 2-3 minutes.

17. Infant Behavior Record (IBR) assessing child temperament #1 [Baseline]

    Two trained observers will use the Infant Behavior Record (IBR; Bayley, 1969; Stifter & Corey, 2001; Stifter et al., 2008) to assess 11 dimensions of child temperament based on their observations of the entire lab session.

18. Infant Behavior Record (IBR) assessing child temperament #2 [Immediately post-intervention]

    Two trained observers will use the Infant Behavior Record (IBR; Bayley, 1969; Stifter & Corey, 2001; Stifter et al., 2008) to assess 11 dimensions of child temperament based on their observations of the entire lab session.

19. Infant Behavior Record (IBR) assessing child temperament #3 [6-month follow-up]

    Two trained observers will use the Infant Behavior Record (IBR; Bayley, 1969; Stifter & Corey, 2001; Stifter et al., 2008) to assess 11 dimensions of child temperament based on their observations of the entire lab session.

20. Experience of Discrimination Scale (EOD) [Baseline]

    Participants' lifetime experience with discrimination will be assessed using the 9-item self-report Experience of Discrimination Scale (EOD; Krieger, 1990; Krieger & Sidney, 1996; Krieger et al., 2005). Following Krieger et al. (2005), investigators included an additional 4 questions about participants' level of worry about experiencing unfair treatment due to their race or ethnicity.

Other Outcome Measures

1. Parent-Reported Demographic Variables [Baseline]

   Demographic variables are parent age, education, occupation, single/living with partner, family income, racial/ethnic identity, as well as the target child's age, sex, race/ethnicity, and whether the child was born prematurely.

2. Observer Ratings of Intervener Treatment Adherence and Competence for COS-P [From COS-P intervention onset to completion, 8 weeks]

   All sessions will be videotaped. Investigators will code a randomly selected 20 percent of Circle of Security Parenting (COS-P) sessions (stratified by intervener) to be coded (with a 30 percent reliability overlap) by independent blind coders for treatment adherence and intervener competence using a COS-P-specific adaptation of the Yale Adherence and Competence Scale (YACS; Carroll et al., 2000). Each session will be coded for COS-P-specific items on two dimensions: Adherence (1 = not at all, 7 = extensively) and Skill Level (competence with which the intervener delivered specific aspects of the intervention, 1 = very poor, 7 = excellent). Items reflect specific manualized content (e.g., COS-P model for understanding child needs) and process (e.g., supporting parent observation skills, building a strong alliance). Scores of competence that are = or > 3 reflect sufficient to excellent competence, whereas scores < 3 reflect lack of competence.

3. Observer Ratings of Intervener Treatment Adherence and Competence for Little Talks [From Little Talks intervention onset to completion, 8 weeks]

   Investigators will code a randomly selected 20 percent of sessions (stratified by intervener) to be coded (with a 30 percent reliability overlap) by independent masked coders for intervener adherence/competence using the Little Talks Fidelity Form (Manz et al., 2017). The Little Talks Fidelity form reflects the specific manualized content of Little Talks in four categories: Little Talks Curriculum fidelity (6 items), Collaborative Goal Setting fidelity (6 items), Home Visitor Decision Making fidelity (2 items), and Parent Collaboration fidelity (6 items). Each item is scored as either 1 = delivered with sufficient competency or 0 = not delivered with sufficient competency. For the purpose of comparing Little Talks intervener competence with COS-P intervener competence, Little Talks Fidelity scores can be used to create a score representing percentage of intervention delivered with sufficient competence (total number of items = 1 / total number of items).

4. COS-P Intervener Adherence Checklist [From COS-P intervention onset to completion, 8 weeks]

   For adherence, interveners will complete a checklist at the end of each session indicating whether or not they accomplished the session goals as outlined in the manual, as well as a standardized COS-P session journal that asks interveners to reflect in writing on two specific instances from the session in which they dealt with particular topics. The fidelity team will review completed checklists and journals weekly to monitor intervention component completion and so prevent implementation drift. Specifically, the fidelity team will monitor whether all components were completed, and alert the intervener to cover any absent material the following week; the following week's session will then be reviewed to ensure the material was covered. The checklist includes both content and process items.

5. Little Talks Intervener Fidelity form (Intervener Rated) [From Little Talks intervention onset to completion, 8 weeks]

   For adherence, interveners will complete the Little Talks Intervener Fidelity form (Manz et al., 2017) at the end of each session. The Little Talks Fidelity form reflects the specific manualized content of Little Talks in four categories: Little Talks Curriculum fidelity (6 items), Collaborative Goal Setting fidelity (6 items), Home Visitor Decision Making fidelity (2 items), and Parent Collaboration fidelity (6 items). Each item is scored as either 1 = delivered with sufficient competency or 0 = not delivered with sufficient competency.

6. Participant Ratings of Intervener Competence [Immediately post-intervention (for both COS-P & Little Talks)]

   Participants will rate their interveners' competence as part of the post-intervention lab assessment using the 12-item Counselor Rating Form-Short (CRF-S; Corrigan & Schmidt, 1983; Wilson & Yager, 1990). Participants in each intervention group (COS-P & Little Talks) will complete these ratings. Participants will rate how much the intervener displays characteristics (e.g., "friendly," "reliable," "prepared") on a scale of 1 (not very) to 7 (very). The CRF-S is a general measure of client perceptions of intervener competence.

7. Participant Ratings of Intervention Service [Immediately post-intervention (for both COS-P & Little Talks)]

   Participant evaluations of the intervention service (Carroll et al., 2007) will be gathered using the widely used (participant-reported) Client Satisfaction Questionnaire (CSQ-8; Nguyen et al., 1983). Participants in each intervention group (COS-P & Little Talks) will complete these ratings. Participants will answer questions about their satisfaction with the service on a 4-point scale (1 reflecting poorer satisfaction, 4 reflecting higher satisfaction).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Parents whose children (age 8 to 36 months) are enrolled in Harrisburg PA and Lehigh Valley PA Early Head Start programs

Exclusion Criteria:

• Parents who are not sufficiently fluent in the language in which COS-P intervention will be conducted (Spanish or English)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland, College Park	College Park	Maryland	United States	20742
2	Lehigh University	Bethlehem	Pennsylvania	United States	18015

Sponsors and Collaborators

• University of Maryland, College Park
• Lehigh University
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Jude Cassidy, Ph.D., University of Maryland, College Park
• Principal Investigator: Susan Woodhouse, Ph.D., Lehigh University

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Manz, P. H., Eisenberg, R., Gernhart, A., Faison, J., Laracy, S., Ridgard, T. & Pinho, T. (2016). Engaging Early Head Start parents in a collaborative inquiry: The co-construction of Little Talks, Early Child Development and Care. doi: 10.1080/03004430.2016.1169177
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• Responsible Party: Jude Cassidy, Professor, University of Maryland, College Park
• ClinicalTrials.gov Identifier: NCT05834907
• Other Study ID Numbers: 1857396-7; 1R01HD105676-01A1
• First Posted: Apr 28, 2023
• Last Update Posted: Apr 28, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jude Cassidy, Professor, University of Maryland, College Park: Parent-Child Relations; Development, Infant; Parenting; Development, Child; Attachment; Home Visiting; Early Intervention

Study Results

No Results Posted as of Apr 28, 2023