Clinical trial NCT05834907: Hands and Hearts Together
Official title: Prevention of Attachment Insecurity, Physiological Dysregulation, and Child Behavior Problems
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parent-Child Relations
Development, Infant
Parenting
Development, Child
Keywords: Parent-Child Relations
Development, Infant
Parenting
Development, Child
Attachment
Home Visiting
Early Intervention
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: Lehigh University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-04-28
Enrollment: 249
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 or are eligible but not yet enrolled in two diverse Early Head Start (EHS) programs.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Strange Situation Procedure (SSP) #1
timeFrame: Baseline
measure: Strange Situation Procedure (SSP) #2
timeFrame: Immediately post-intervention
measure: Strange Situation Procedure (SSP) #3
timeFrame: 6-month follow up
measure: Macarthur Preschool Strange Situation (PACS) #1
timeFrame: Baseline
measure: Macarthur Preschool Strange Situation (PACS) #2
timeFrame: Immediately post-intervention
measure: Macarthur Preschool Strange Situation (PACS) #3
timeFrame: 6-month follow up
measure: Cortisol Stress Reactivity and Recovery #1
timeFrame: Baseline
measure: Cortisol Stress Reactivity and Recovery #2
timeFrame: Immediately post-intervention
measure: Cortisol Stress Reactivity and Recovery #3
timeFrame: 6-month follow up
measure: Child Behavior Checklist (CBCL) #1
timeFrame: Baseline
measure: Child Behavior Checklist (CBCL) #2
timeFrame: Immediately post-intervention
measure: Child Behavior Checklist (CBCL) #3
timeFrame: 6-month follow up
measure: Infant-Toddler Social and Emotional Assessment (ITSEA) #1
timeFrame: Baseline
measure: Infant-Toddler Social and Emotional Assessment (ITSEA) #2
timeFrame: Immediately post-intervention
measure: Infant-Toddler Social and Emotional Assessment (ITSEA) #3
timeFrame: 6-month follow up
measure: Parental Emotional Responses to Child Distress #1
timeFrame: Baseline
measure: Parental Emotional Responses to Child Distress #2
timeFrame: Immediately post-intervention
measure: Parental Emotional Responses to Child Distress #3
timeFrame: 6-month follow up
measure: Electrodermal Activity (EDA) arousal #1
timeFrame: Baseline
measure: Electrodermal Activity (EDA) arousal #2
timeFrame: Immediately post-intervention
measure: Electrodermal Activity (EDA) arousal #3
timeFrame: 6-month follow up
measure: Respiratory Sinus Arrhythmia (RSA) #1
timeFrame: Baseline
measure: Respiratory Sinus Arrhythmia (RSA) #2
timeFrame: Immediately post-intervention
measure: Respiratory Sinus Arrhythmia (RSA) #3
timeFrame: 6-month follow up
measure: Coping with Toddlers' Negative Emotions Scale (CTNES) #1
timeFrame: Baseline
measure: Coping with Toddlers' Negative Emotions Scale (CTNES) #2
timeFrame: Immediately post-intervention
measure: Coping with Toddlers' Negative Emotions Scale (CTNES) #3
timeFrame: 6 month follow up
measure: Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #1
timeFrame: Baseline
measure: Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #1
timeFrame: Baseline
measure: Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #2
timeFrame: Immediately post-intervention
measure: Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #2
timeFrame: Immediately post-intervention
measure: Stranger Approach Lab-TAB Task to Assess Parental Behavioral Sensitivity #3
timeFrame: 6-month follow up
measure: Jar Lab-TAB Task to Assess Parental Behavioral Sensitivity #3
timeFrame: 6-month follow up
Secondary outcomes:
measure: Financial Stress Questionnaire #1
timeFrame: Baseline
measure: Financial Stress Questionnaire #2
timeFrame: Immediately post-intervention
measure: Financial Stress Questionnaire #3
timeFrame: 6-month follow-up
measure: O'Leary-Porter Overt Hostility Scale #1
timeFrame: Baseline
measure: O'Leary-Porter Overt Hostility Scale #2
timeFrame: Immediately post-intervention
measure: O'Leary-Porter Overt Hostility Scale #3
timeFrame: 6-month follow-up
measure: Adverse Childhood Experiences Questionnaire (ACE-Q)
timeFrame: Baseline
measure: Role Overload #1
timeFrame: Baseline
measure: Role Overload #2
timeFrame: Immediately post-intervention
measure: Role Overload #3
timeFrame: 6-month follow-up
measure: My Exposure to Violence
timeFrame: Baseline
measure: Experiences in Close Relationships Scale (ECR) #1
timeFrame: Baseline
measure: Experiences in Close Relationships Scale (ECR) #2
timeFrame: Immediately post-intervention
measure: Experiences in Close Relationships Scale (ECR) #3
timeFrame: 6-month follow-up
measure: Center for Epidemiologic Studies Depression Scale (CES-D) #1
timeFrame: Baseline
measure: Center for Epidemiologic Studies Depression Scale (CES-D) #2
timeFrame: Immediately post-intervention
measure: Center for Epidemiologic Studies Depression Scale (CES-D) #3
timeFrame: 6-month follow-up
measure: Child Behavior Questionnaire
timeFrame: Baseline
measure: Stranger Approach Lab-TAB Task to assess child temperament
timeFrame: Baseline
measure: Behind Barrier Lab-TAB Task to assess child temperament
timeFrame: Baseline
measure: Jar Lab-TAB Task to assess child temperament
timeFrame: Baseline
measure: Spider Lab-TAB Task to assess child temperament
timeFrame: Baseline
measure: Infant Behavior Record (IBR) assessing child temperament #1
timeFrame: Baseline
measure: Infant Behavior Record (IBR) assessing child temperament #2
timeFrame: Immediately post-intervention
measure: Infant Behavior Record (IBR) assessing child temperament #3
timeFrame: 6-month follow-up
measure: Experience of Discrimination Scale (EOD)
timeFrame: Baseline
Other outcomes:
measure: Parent-Reported Demographic Variables #1
timeFrame: Baseline
measure: Parent-Reported Demographic Variables #2
timeFrame: Immediately post-intervention
measure: Parent-Reported Demographic Variables #3
timeFrame: 6-month follow-up
measure: Observer Ratings of Intervener Treatment Adherence and Competence for COS-P
timeFrame: From COS-P intervention onset to completion, 8 weeks
measure: Observer Ratings of Intervener Treatment Adherence and Competence for Little Talks
timeFrame: From Little Talks intervention onset to completion, 8 weeks
measure: COS-P Intervener Adherence Checklist
timeFrame: From COS-P intervention onset to completion, 8 weeks
measure: Little Talks Intervener Fidelity form (Intervener Rated)
timeFrame: From Little Talks intervention onset to completion, 8 weeks
measure: Participant Ratings of Intervener Competence
timeFrame: Immediately post-intervention (for both COS-P & Little Talks)
measure: Participant Ratings of Intervention Service
timeFrame: Immediately post-intervention (for both COS-P & Little Talks)
Locations:
city: College Park
country: United States
facility: University of Maryland, College Park
state: Maryland
city: Bethlehem
country: United States
facility: Lehigh University
state: Pennsylvania
Study officials:
affiliation: University of Maryland, College Park
name: Jude Cassidy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lehigh University
name: Susan Woodhouse, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Achenbach, T. M., & Rescorla, L. A. (2000). Manual for the ASEBA Preschool Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
citation: Ainsworth, M., Blehar, M., Waters, E., & Wall, S. (1978). Patterns of attachment. Erlbaum.
citation: Bayley, N. 1969. Bayley scales of infant development. New York: Psychological Corp.
citation: Bernard K, Dozier M. Examining infants' cortisol responses to laboratory tasks among children varying in attachment disorganization: stress reactivity or return to baseline? Dev Psychol. 2010 Nov;46(6):1771-8. doi: 10.1037/a0020660.
citation: Bowlby, J. (1988). A secure base. Basic Books.
citation: Brennan, K. A., Clark, C. L., & Shaver, P. R. (1998). Self-report measurement of adult attachment: An integrative overview. In J. A. Simpson, W. S. Rholes, J. A. Simpson, W. S. Rholes (Eds.), Attachment theory and close relationships (pp. 46-76). Guilford.
citation: Carroll KM, Nich C, Sifry RL, Nuro KF, Frankforter TL, Ball SA, Fenton L, Rounsaville BJ. A general system for evaluating therapist adherence and competence in psychotherapy research in the addictions. Drug Alcohol Depend. 2000 Jan 1;57(3):225-38. doi: 10.1016/s0376-8716(99)00049-6.
citation: Carter, A. S., & Briggs-Gowan, M. J. (2000). The Infant-Toddler Social and Emotional Assessment (ITSEA). Unpublished Manual. University of Massachusetts Boston Department of Psychology, Boston, MA. Yale University, New Haven, CT. Available by request at alice.carter@umb.edu.
citation: Carter AS, Briggs-Gowan MJ, Jones SM, Little TD. The Infant-Toddler Social and Emotional Assessment (ITSEA): factor structure, reliability, and validity. J Abnorm Child Psychol. 2003 Oct;31(5):495-514. doi: 10.1023/a:1025449031360.
citation: Cassidy, J., & Marvin, R. S., with MacArthur Attachment Working Group (1992). Attachment organization in preschool children: Procedures and coding manual (4th ed.). Unpublished manuscript, Department of Psychology, University of Virginia, Charlottesville, Virginia.
citation: Conduct Problems Prevention Research Group (CPPRG). (1994). Financial Stress Questionnaire. Available from the Fast Track Project Web site: http://www.fasttrackproject.org
citation: Corrigan, J., & Schmidt, L. (1983). Development and validation of revisions in the Counselor Rating Form. Journal of Counseling Psychology, 30, 64-75. doi: 10.1037/0022-0167.30.1.64
citation: Felitti, V. J., Anda, R. F., Nordenberg, D., & Williamson, D. F. (1998). Adverse childhood experiences and health outcomes in adults: The Ace study. Journal of Family and Consumer Sciences, 90, 31.
citation: Goldsmith, H. H., & Rothbart, M. K. (1999). The Laboratory Temperament Assessment Battery. Locomotor Version 3.1, Description of Procedures. University of Wisconsin, Madison, WI.
citation: Gudmundson JA, Leerkes EM. Links between mothers' coping styles, toddler reactivity, and sensitivity to toddler's negative emotions. Infant Behav Dev. 2012 Feb;35(1):158-66. doi: 10.1016/j.infbeh.2011.07.004. Epub 2011 Sep 7.
citation: Gunnar, M. R., & Herrera, A. M. (2013). The development of stress reactivity: A neurobiological perspective. In P. D. Zelazo (Ed.), The Oxford handbook of developmental psychology, Vol. 2. Self and other (pp. 45-80). Oxford University Press.
citation: Johnson PL, O'Leary KD. Parental behavior patterns and conduct disorders in girls. J Abnorm Child Psychol. 1987 Dec;15(4):573-81. doi: 10.1007/BF00917242.
citation: Krieger N. Racial and gender discrimination: risk factors for high blood pressure? Soc Sci Med. 1990;30(12):1273-81. doi: 10.1016/0277-9536(90)90307-e.
citation: Krieger N, Sidney S. Racial discrimination and blood pressure: the CARDIA Study of young black and white adults. Am J Public Health. 1996 Oct;86(10):1370-8. doi: 10.2105/ajph.86.10.1370.
citation: Krieger N, Smith K, Naishadham D, Hartman C, Barbeau EM. Experiences of discrimination: validity and reliability of a self-report measure for population health research on racism and health. Soc Sci Med. 2005 Oct;61(7):1576-96. doi: 10.1016/j.socscimed.2005.03.006. Epub 2005 Apr 21.
citation: Leerkes EM. Predictors of Maternal Sensitivity to Infant Distress. Parent Sci Pract. 2010 Jul 1;10(3):219-239. doi: 10.1080/15295190903290840.
citation: Leerkes, E. M., Crockenberg, S. C., & Burrous, E. (2004). Identifying components of maternal sensitivity to infant distress: The role of maternal emotional competencies. Parenting: Science and Practice, 4, 1-23. doi:10.1207/s15327922par04011
citation: Leerkes EM, Parade SH, Gudmundson JA. Mothers' emotional reactions to crying pose risk for subsequent attachment insecurity. J Fam Psychol. 2011 Oct;25(5):635-43. doi: 10.1037/a0023654.
citation: Luijk MP, Saridjan N, Tharner A, van Ijzendoorn MH, Bakermans-Kranenburg MJ, Jaddoe VW, Hofman A, Verhulst FC, Tiemeier H. Attachment, depression, and cortisol: Deviant patterns in insecure-resistant and disorganized infants. Dev Psychobiol. 2010 Jul;52(5):441-52. doi: 10.1002/dev.20446.
citation: 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
citation: Manz, P. H., Power, T. J., Roggman, L. A., Eisenberg, R. A., Gernhart, A., Faison, J., Ridgard, T., Wallace, L. E., & Whitenack, J. M. (2017). Integrating the Little Talks intervention into Early Head Start: An experimental examination of implementation supports involving fidelity monitoring and performance feedback. Children and Youth Services Review, 79, 87-96. doi 10.1016/j.childyouth.2017.05.034
citation: Mikulincer, M., & Shaver, P. R. (2016). Attachment in adulthood: Structure, dynamics, and change (2nd ed.). Guilford.
citation: Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299-313. doi: 10.1016/0149-7189(83)90010-1.
citation: Child care and mother-child interaction in the first 3 years of life. NICHD Early Child Care Research Network. Dev Psychol. 1999 Nov;35(6):1399-413.
citation: Porter B, O'Leary KD. Marital discord and childhood behavior problems. J Abnorm Child Psychol. 1980 Sep;8(3):287-95. doi: 10.1007/BF00916376.
citation: Putnam SP, Rothbart MK. Development of short and very short forms of the Children's Behavior Questionnaire. J Pers Assess. 2006 Aug;87(1):102-12. doi: 10.1207/s15327752jpa8701_09.
citation: Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1, 385-401. doi: 10.1177/014662167700100306
citation: Reilly, M. D. (1982). Working wives and convenience consumption. Journal of Consumer Research, 8(4), 407-418. https://doi.org/10.1086/208881
citation: Selner-O'Hagan MB, Kindlon DJ, Buka SL, Raudenbush SW, Earls FJ. Assessing exposure to violence in urban youth. J Child Psychol Psychiatry. 1998 Feb;39(2):215-24.
citation: Solomon, J., & George, C. (2016). The measurement of attachment security and related constructs in infancy and early childhood. In J. Cassidy & P. R. Shaver (Eds.), Handbook of attachment: Theory, research, and clinical applications (3rd ed., pp. 366-398). Guilford.
citation: Spinrad TL, Eisenberg N, Gaertner B, Popp T, Smith CL, Kupfer A, Greving K, Liew J, Hofer C. Relations of maternal socialization and toddlers' effortful control to children's adjustment and social competence. Dev Psychol. 2007 Sep;43(5):1170-86. doi: 10.1037/0012-1649.43.5.1170.
citation: Stifter, C. A., & Corey, J. M. (2001). Vagal regulation and observed social behavior in infancy. Social Development, 10(2), 189-201. https://doi.org/10.1111/1467-9507.00158
citation: Stifter CA, Willoughby MT, Towe-Goodman N; The Family Life Project Key Investigators. Agree or Agree to Disagree? Assessing the Convergence between Parents and Observers on Infant Temperament. Infant Child Dev. 2008 Aug 1;17(4):407-426. doi: 10.1002/icd.584.
citation: Thiagarajan, P., Chakrabarty, S., & Taylor, R. D. (2006). A confirmatory factor analysis of Reilly's Role Overload Scale. Educational and Psychological Measurement, 66(4), 657-666. https://doi.org/10.1177/0013164405282452
citation: Thompson LA, Morgan G, Jurado KA, Gunnar MR. III. JUSTIFICATION FOR CORTISOL RESPONSE CATEGORIES. Monogr Soc Res Child Dev. 2015 Dec;80(4):40-7. doi: 10.1111/mono.12210. No abstract available.
citation: Wilson, F., & Yager, G. (1990). Concurrent and construct validity of three counselor social influence instruments. Measurement and Evaluation in Counseling and Development, 23, 52-66.