Clinical trial NCT03260816: Advancing Child Competencies by Extending Supported Services (ACCESS) for Families Program
Official title: Advancing Child Competencies by Extending Supported Services (ACCESS) for Families Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Delay
Disruptive Behavior
Keywords: Preschoolers
Developmental Delay
Disruptive Behavior
Early Intervention
Parent-Child Interaction Therapy (PCIT)
Telehealth
Telemental Health
Telepsychiatry
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: University of Miami
name: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-08-24
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Child Behavior Checklist, Ages 1.5-5 (CBCL, 1.5-5)
timeFrame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Baseline (Week 0), Post (Week 21), Follow-Up One (Week 42) and Follow-Up Two (Week 68)
measure: Sutter-Eyberg Behavior Inventory, Revised (SESBI-R)
timeFrame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
measure: Multidimensional Assessment of Preschool Disruptive Behavior (MAP-DB): Temper Loss Scale
timeFrame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
measure: Impossibly Perfect Circle (IPC)
timeFrame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
measure: Child Rearing Inventory (CRI)
timeFrame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
measure: Parenting Practices Inventory (PPI)
timeFrame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
measure: Parent-Child Book Reading
timeFrame: Change from Week 0, Week 21, Week 42 and Week 68
measure: Family Impact Questionnaire (FIQ)
timeFrame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
measure: Depression, Anxiety, Stress Scale- 21 (DASS-21)
timeFrame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
measure: Bracken School Readiness Assessment-3 (BSRA-3)
timeFrame: Change from Week 0, Week 21, Week 42 and Week 68
measure: Preschool Language Scale-5 (PLS-5)
timeFrame: Change from Week 0, Week 21, Week 42 and Week 68
measure: Clinical Global Impression (CGI-I)
timeFrame: Week 21
measure: Technology Experience and Attitude Rating Scale (TEARS)
timeFrame: Change in weekly ratings from Week 0 to Week 21
measure: Therapy Attitude Inventory (TAI)
timeFrame: Week 21
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: Week 21
measure: Telepresence in Videoconferencing Scale
timeFrame: Week 21
measure: Barriers to Treatment Participation Scale (BTPS)
timeFrame: Week 21
measure: Parental Attitudes Toward Psychological Services Inventory (PATPSI): Stigmatization Scale and Help-Seeking Attitudes Scale
timeFrame: Baseline (Week 0)
measure: Child's Sleep Habits Questionnaire
timeFrame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
measure: Dyadic Parent-Child Interaction Coding System-IV (DPICS-4)
timeFrame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
measure: Eyberg Child Behavior Inventory (ECBI)
timeFrame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami, Early Steps North
state: Florida
city: Miami
country: United States
facility: Florida International University
state: Florida
city: Palmetto Bay
country: United States
facility: Nicklaus Children's Hospital, Early Steps South
state: Florida
Study officials:
affiliation: Florida International University
name: Daniel M. Bagner, Ph.D., ABPP
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida International University
name: Jonathan S. Comer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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