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Advancing Child Competencies by Extending Supported Services (ACCESS) for Families Program (ACCESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03260816
Recruitment Status : Active, not recruiting
First Posted : August 24, 2017
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
University of Miami
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Florida International University

Brief Summary:
The Advancing Child Competencies by Extending Supported Services (ACCESS) for Families Program is a study funded by the National Institutes of Health to explore behavior and developmental problems among young children aging out of Early Steps (Part C). All families will participate in five evaluations in their home to learn more about their child's behavior and development. Families also may receive treatment designed to help change their child's behaviors that will be conducted over the Internet using a tablet.

Condition or disease Intervention/treatment Phase
Developmental Delay Disruptive Behavior Behavioral: Internet-delivered Parent-Child Interaction Therapy (I-PCIT) Other: Referrals as Usual (RAU) Not Applicable

Detailed Description:
The proposed study will evaluate, via a randomized controlled trial, the incremental utility of I-PCIT for disruptive behavioral problems in traditionally underserved young children with developmental delay (DD) from predominantly economically disadvantaged and ethnic and racial minority backgrounds. Specifically, the investigators are interested in the impact of I-PCIT on child disruptive behavior problems, parenting practices, parental distress, and pre-academic skills relative to traditional referrals as usual (RAU) among youth aging out of Part C EI services and transitioning from home-based family services to school-based special education services. A secondary goal is to evaluate potential moderators and mediators that explain under which circumstances, for whom, and through which pathways I-PCIT is most effective for young children with DD. Our primary aims are (1) to evaluate the immediate and one-year impact of I-PCIT on (1a) disruptive behavior problems in young children with DD, as well as (1b) parenting practices and (1c) parental distress in parents of young children with DD; (2) to evaluate the impact of I-PCIT on pre-academic skills among young children with DD; and (3) to evaluate (3a) family retention, (3b) engagement, and (3c) satisfaction associated with I-PCIT in young children with DD. Our secondary aim is to examine potential moderators and mediators of response to I-PCIT for disruptive behavior problems in young children with DD. Specifically, the investigators are interested in the extent to which technological literacy and access (4a) moderate I-PCIT efficacy, such that I-PCIT efficacy will be weaker among families with poorer technological literacy and/or access, and the extent to which traditional barriers to care (4b) moderate I-PCIT efficacy, such that the incremental efficacy of I-PCIT over RAU will be strongest among families with geographic, transportation and/or childcare obstacles to in-person services. Finally, the investigators hypothesize that I-PCIT will yield changes in child behavior and pre-academic skills indirectly through direct effects on parenting practices (4c). Specifically, changes in parental consistency, warmth, follow-through, and effective discipline will mediate observed I-PCIT efficacy, such that these treatment-related parenting changes will account for observed differences in child disruptive behavior problems and pre-academic skills.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial in which participants are randomly assigned to either receive Internet-delivered Parent-Child Interaction Therapy (I-PCIT) or referrals as usual (RAU).
Masking: Single (Outcomes Assessor)
Masking Description: Independent evaluators and coders assessing response over time are kept unaware of the condition to which each participant is assigned.
Primary Purpose: Treatment
Official Title: Advancing Child Competencies by Extending Supported Services (ACCESS) for Families Program
Actual Study Start Date : March 16, 2016
Estimated Primary Completion Date : March 16, 2021
Estimated Study Completion Date : March 16, 2021

Arm Intervention/treatment
Experimental: Internet-Delivered Parent Training
Families will receive weekly sessions of Internet-delivered Parent-Child Interaction Therapy (I-PCIT), a short-term parent-training intervention emphasizing positive attention, consistency, problem-solving, and communication. Using videoconferencing, webcams, and wireless Bluetooth earpieces, I-PCIT therapists provide in-the-moment feedback to parents during live parent-child interactions.
Behavioral: Internet-delivered Parent-Child Interaction Therapy (I-PCIT)
Families assigned to the Internet-delivered Parent-Child Interaction Therapy (I-PCIT) group will receive Internet-delivered weekly sessions of a short-term parent-training intervention emphasizing positive attention, consistency, problem-solving, and communication. Using videoconferencing, webcams, and wireless Bluetooth earpieces, I-PCIT therapists provide in-the-moment feedback to parents during live parent-child interactions.

Active Comparator: Referrals as Usual (RAU)
Families in the referrals as usual (RAU) group will be referred to services as usual in their Early Intervention exit interview, which includes a variety of clinic-based mental health services at local community agencies. At each assessment, the access and extent of participation in other services will be monitored.
Other: Referrals as Usual (RAU)
Families assigned to RAU will participate in services referred by their Early Steps team, as per usual care.




Primary Outcome Measures :
  1. Child Behavior Checklist, Ages 1.5-5 (CBCL, 1.5-5) [ Time Frame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68 ]
    The Child Behavior Checklist 1.5-5 (CBCL/1.5-5; Achenbach & Rescorla, 2001) is a 99-item caregiver- report questionnaire of behavioral, emotional, and social problems in children between the ages of 18 months and 5 years. In the current study the externalizing behavior problem scale will be used to screen children into the study (T- score = 60), and the following subscales will be used as outcomes: aggressive behavior, attention problems, attention-deficit/hyperactivity problems, emotionally reactive, and oppositional defiant problems.


Secondary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: Baseline (Week 0), Post (Week 21), Follow-Up One (Week 42) and Follow-Up Two (Week 68) ]
    A weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters.

  2. Sutter-Eyberg Behavior Inventory, Revised (SESBI-R) [ Time Frame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68 ]
    The Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R; Eyberg & Pincus, 1999) is a teacher rating scale of disruptive behaviors at school in children as young as 2 years, and the Intensity and Problem scales will be used as outcome measures for participants in school to assess generalization of improvement in child disruptive behavior to the classroom setting.

  3. Multidimensional Assessment of Preschool Disruptive Behavior (MAP-DB): Temper Loss Scale [ Time Frame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68 ]
    The Temper Loss Scale of the Multidimensional Assessment of Preschool Disruptive Behavior (MAP-DB; Wakschlag et al., 2014) assesses temper loss in terms of tantrum features and anger regulation.

  4. Impossibly Perfect Circle (IPC) [ Time Frame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68 ]
    Children will complete a self-regulation task called the Impossibility Perfect Circles (IPC; Goldsmith & Reilly, 1993) task in which the child is asked to draw a perfect circle several times. The purpose of this task is to code how well the child is regulating their behaviors and emotions during challenging tasks.

  5. Child Rearing Inventory (CRI) [ Time Frame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68 ]
    The Child Rearing Inventory (CRI; Brestan et al., 2003) is an 11-item caregiver-report measure of caregivers' ability to tolerate misbehavior and will also be used as an outcome measure of parenting practices.

  6. Parenting Practices Inventory (PPI) [ Time Frame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68 ]
    The Parenting Practices Inventory (PPI; Webster-Stratton et al., 2004)) is a 72-item caregiver-report questionnaire designed to measure caregiver disciplinary styles and strategies. The PPI is designed to measure parenting practices using the following subscales: appropriate discipline, harsh and inconsistent discipline, positive verbal discipline, monitoring, physical punishment, praise and incentives, and clear expectations.

  7. Parent-Child Book Reading [ Time Frame: Change from Week 0, Week 21, Week 42 and Week 68 ]
    The caregiver-child book- reading procedure will consist of one age-appropriate book (The Way I Feel by Janan Cain; Cain, 2005) which also has Spanish version (Asi me siento yo by Janan Cain; Cain, 2009). Caregivers will be instructed to describe the books to their children like they would normally for 5 minutes. This book is intended to elicit emotion talk as it includes emotional content, but also depicted multiple scenes, events, and objects that caregivers could talk about in addition to or instead of emotions, thereby permitting the capture of differences in caregivers' predilection to discuss emotions with their children.

  8. Family Impact Questionnaire (FIQ) [ Time Frame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68 ]
    The Family Impact Questionnaire (FIQ; Donenberg & Baker, 1993) is a 50-item caregiver-report questionnaire of stress and strain, selected over other measures as an outcome of caregiver distress because it has been Child Disruptive Symptoms.

  9. Depression, Anxiety, Stress Scale- 21 (DASS-21) [ Time Frame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68 ]
    The Depression, Anxiety, Stress Scale-21 (DASS21; Lovibond & Lovibond, 1995) is a clinical assessment that measures the three related states of depression, anxiety and stress.

  10. Bracken School Readiness Assessment-3 (BSRA-3) [ Time Frame: Change from Week 0, Week 21, Week 42 and Week 68 ]
    Bracken School Readiness Assessment-3 (BSRA-3; Bracken, 2007) is an individual cognitive test designed for children examining the areas of colors, letters, numbers/counting, sizes, comparisons, and shapes.

  11. Preschool Language Scale-5 (PLS-5) [ Time Frame: Change from Week 0, Week 21, Week 42 and Week 68 ]
    The Preschool Language Scale-5 (PLS-5; Zimmerman, Steiner, & Pond, 2011) is an assessment of developmental language skills, specifically auditory comprehension and expressive communication.

  12. Clinical Global Impression (CGI-I) [ Time Frame: Week 21 ]
    The Clinical Global Impression - Improvement scale (CGI-I; Guy, 1976) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.

  13. Technology Experience and Attitude Rating Scale (TEARS) [ Time Frame: Change in weekly ratings from Week 0 to Week 21 ]
    The Technology Experience and Attitude Rating Scale (TEARS) will be administered to assess caregiver and child technology use and literacy as a potential moderator of treatment response.

  14. Therapy Attitude Inventory (TAI) [ Time Frame: Week 21 ]
    The Therapy Attitude Inventory (TAI; Brestan et al. 2000) is a 10-item parent-report of satisfaction with the process and outcome of parent-training interventions.

  15. Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: Week 21 ]
    The Client Satisfaction Questionnaire-8 (CSQ-8; Nguyen et al., 1983) is an 8-item generic measure of clients' perceptions of the value of services received.

  16. Telepresence in Videoconferencing Scale [ Time Frame: Week 21 ]
    The Telepresence in Videoconferencing Scale will be administered to assess caregiver experience interacting within video web-conferencing platform.

  17. Barriers to Treatment Participation Scale (BTPS) [ Time Frame: Week 21 ]
    The Barriers to Treatment Participation Scale (BTPS; Kazdin et al. 1997) is a 44-item measure of perceived barriers to treatment participation.

  18. Parental Attitudes Toward Psychological Services Inventory (PATPSI): Stigmatization Scale and Help-Seeking Attitudes Scale [ Time Frame: Baseline (Week 0) ]
    Two scales from the Parental Attitudes Toward Psychological Services Inventory (PATPSI; Turner, 2012) will be administered: help- seeking attitudes scale and the stigmatization scale. The PATPSI is a measure to assess caregivers' attitudes toward outpatient mental health services.

  19. Child's Sleep Habits Questionnaire [ Time Frame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68 ]
    The Children's Sleep Habits Questionnaire (CSHQ; Owens et al. 2000) is a 33-item parent questionnaire designed to examine sleep behavior in young children and thus screen for the most common sleep problems.

  20. Dyadic Parent-Child Interaction Coding System-IV (DPICS-4) [ Time Frame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68 ]
    The Dyadic Parent-Child Interaction Coding System-4th Ed (DPICS-IV; Eyberg et al., 2013) is a structured behavioral observation coding system assessing caregiver-child interactions. Observed parenting behaviors will be coded during a 5-min child-led play and combined into two categories of positive (praises, behavior descriptions, and reflections) and negative (questions, commands, and negative talk) verbalizations, reflecting behaviors caregivers are taught to use and avoid in PCIT. Additionally, child compliance will be assessed during a 5-min caregiver-led play and 5-min clean up situation and will be examined as an objective outcome of child behavior. The positive and negative caregiver verbalizations will be examined as both outcomes and candidate mediators of treatment, and child compliance will be examined as an outcome.

  21. Eyberg Child Behavior Inventory (ECBI) [ Time Frame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68 ]
    The Eyberg Child Behavior Inventory (ECBI; Eyberg & Pincus, 1999) is a 36-item caregiver-report of disruptive behavior problems in children as young as 2 years. The Intensity and Problem scales will be used to assess changes in child disruptive behavior.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Young children aging out of Part C EI services (mean age = 34.50 months) and at least 1 primary caretaker, which in most cases will be the mother
  • Elevated Child Behavior Checklist Externalizing Problems scale at least in the borderline clinical range (i.e., T-score = 60)
  • English-speaking or Spanish-speaking primary caretaker and child.

Exclusion Criteria:

  • Child receiving an unstable dose of medication (i.e., changes within the past 4 weeks) to manage behavior difficulties
  • History of severe physical impairment (e.g., deafness, blindness) in the child or primary caretaker
  • Severe autism spectrum disorder impairment (i.e., Social Responsiveness Scale, Second Edition > 75)
  • Significant cognitive delay in the parent (i.e., estimated IQ score < 70 on the two-subtest [vocabulary and matrix reasoning] version of the Wechsler Abbreviated Scale of Intelligence for those speaking English or an average standard score < 4 on the vocabulary and matrix reasoning subtests of the Escala de Inteligencia Wechsler Para Adultos - Third Edition for those speaking Spanish)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260816


Locations
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United States, Florida
University of Miami, Early Steps North
Miami, Florida, United States, 33136
Florida International University
Miami, Florida, United States, 33199
Nicklaus Children's Hospital, Early Steps South
Palmetto Bay, Florida, United States, 33157
Sponsors and Collaborators
Florida International University
University of Miami
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Daniel M. Bagner, Ph.D., ABPP Florida International University
Principal Investigator: Jonathan S. Comer, Ph.D. Florida International University
Additional Information:
Publications:
Achenbach, T. M., & Rescorla, L. A. (2001). Manual for the ASEBA Preschool Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
Bracken, B. A. (2007). Bracken School Readiness Assessment. San Antonio, TX: Psychological Corporation.
Brestan , E. V. , Eyberg , S. M. , Algina , J. , Bennett Johnson , S. , & Boggs , S. R. ( 2003 ). How annoying is it? Defining parental tolerance for child misbehavior. Child and Family Behavior Therapy, 25, 1-15.
Brestan, E. V., Jacobs, J. R., Rayfield, A. D., & Eyberg, S. M. (2000). A consumer satisfaction measure for parent-child treatments and its relation to measures of child behavior change. Behavior Therapy, 30, 17-30.
Cain, J. (2005). The Way I Feel. Chicago, IL: Parenting Press.
Cain, J. (2009). Asi Me Sientol. Chicago, IL: Parenting Press.
Eyberg, S. M., & Funderburk, B. W. (2011). Parent-Child Interaction Therapy Protocol. Gainesville, FL: PCIT International.
Eyberg, S. M., Nelson, M. M., Ginn, N. C., Bhuiyan, N., & Boggs, S. R. (2013). Dyadic Parent- Child Interaction Coding System (DPICS): Comprehensive manual for research and training. Gainesville, FL: PCIT International.
Eyberg, S. M., & Pincus, D. (1999). Eyberg Child Behavior Inventory and Sutter-Eyberg Student Behavior Inventory: Professional manual. Odessa, FL: Psychological Assessment Resources.
Goldsmith, H.H., Reilly, J (1993). Laboratory Assessment of Temperament Preschool Version. University of Oregon.
Guy, W. (1976). ECDEU assessment manual for psychopharmacology. Rockville, MD: US Department of Heath, Education, and Welfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration.
Hall, L. (1983). Social supports, everyday stressors, and maternal mental health (Unpublished doctoral dissertation). University of North Carolina at Chapel Hill.
Lovibond, S.H. & Lovibond, P.F. (1995). Manual for the Depression Anxiety & Stress Scales. (2 Ed.)Sydney: Psychology Foundation.
Newborg J. (2005). Battelle developmental inventory-second edition. Itasca, IL: Riverside.
Newborg J. (2016) Battelle developmental inventory-second edition normative update. Itasca, IL: Riverside.
Pons, J. I., Flores-Pabón, L., Matías-Carrelo, L., Rodríguez, M., Rosario-Hernández, E., Rodríguez, J. M., . . . Yang, J. (2008). Confiabilidad de la Escala de Inteligencia Wechsler para Adultos Versión III, Puerto Rico (EIWA-III). Revista Puertorriqueña de Psicología, 19, 112-132.
Wechsler, D. (1999). Wechsler Abbreviated Scale of Intelligence. San Antonio, TX: Pychological Corportation.
Zimmerman, I.L., Steiner, V.G. and Pond, R.E., 2011, Preschool Language Scale, 5th Edition. (San Antonio, TX: The Psychological Corporation).

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Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT03260816    
Other Study ID Numbers: IRB-15-0134
R01HD084497 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will use a controlled access approach, using a robust system to review requests and provide secure access to de-identified data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Florida International University:
Preschoolers
Developmental Delay
Disruptive Behavior
Early Intervention
Parent-Child Interaction Therapy (PCIT)
Telehealth
Telemental Health
Telepsychiatry
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms