About this trial
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 or are eligible but not yet enrolled in two diverse Early Head Start (EHS) programs.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Parents whose children (age 8 to 36 months) are enrolled or are eligible to be enrolled in Harrisburg PA and Lehigh Valley PA Early Head Start programs
Disqualifiers
Parents who are not sufficiently fluent in the language in which COS-P intervention will be conducted (Spanish or English)
Trial design
Parallel
Treatments tested in this trial
Circle of Security Parenting
BehavioralCOS-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.
Little Talks
BehavioralLittle 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.
Treatment groups
Trial outcomes
Primary outcomes
Strange Situation Procedure (SSP) #1
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
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
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
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.
Secondary outcomes
Financial Stress Questionnaire #1
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).
Financial Stress Questionnaire #2
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).
Financial Stress Questionnaire #3
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).
O'Leary-Porter Overt Hostility Scale #1
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.
Other outcomes
Parent-Reported Demographic Variables #1
Demographic variables are parent age, education, occupation, language(s) spoken, number of children, people living in the household, relationship status, single/living with partner, family income, racial/ethnic identity, enrollment status in Early Head Starts, experience of homelessness, whether they receive benefits from Temporary Assistance for Needy Families or Supplemental Security Income, as well as the target child's age, sex, race/ethnicity, childcare, whether the child was born prematurely, and autism diagnosis.
Parent-Reported Demographic Variables #2
Immediately post-intervention, caregivers will answer a selected set of demographic variables including their occupation, number of children, people living in the household, relationship status, and autism diagnosis.
Parent-Reported Demographic Variables #3
At the 6-month follow-up, caregivers will answer a selected set of demographic variables including their occupation, number of children, people living in the household, relationship status, and autism diagnosis.
Observer Ratings of Intervener Treatment Adherence and Competence for COS-P
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.
Sponsors and contacts
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University of Maryland, College Park
Lead sponsor
Lehigh University
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator