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

June 1, 2022 updated by: Florida International University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33199
        • Florida International University
      • Miami, Florida, United States, 33136
        • University of Miami, Early Steps North
      • Palmetto Bay, Florida, United States, 33157
        • Nicklaus Children's Hospital, Early Steps South

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from Week 0, Week 8, Week 21, Week 42 and Week 68

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Week 0), Post (Week 21), Follow-Up One (Week 42) and Follow-Up Two (Week 68)
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.
Change from Week 0, Week 8, Week 21, Week 42 and Week 68
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.
Change from Week 0, Week 8, Week 21, Week 42 and Week 68
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.
Change from Week 0, Week 8, Week 21, Week 42 and Week 68
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.
Change from Week 0, Week 8, Week 21, Week 42 and Week 68
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.
Change from Week 0, Week 8, Week 21, Week 42 and Week 68
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.
Change from Week 0, Week 21, Week 42 and Week 68
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.
Change from Week 0, Week 8, Week 21, Week 42 and Week 68
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.
Change from Week 0, Week 8, Week 21, Week 42 and Week 68
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.
Change from Week 0, Week 21, Week 42 and Week 68
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.
Change from Week 0, Week 21, Week 42 and Week 68
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.
Week 21
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.
Change in weekly ratings from Week 0 to Week 21
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.
Week 21
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.
Week 21
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.
Week 21
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.
Week 21
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.
Baseline (Week 0)
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.
Change from Week 0, Week 8, Week 21, Week 42 and Week 68
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.
Change from Week 0, Week 8, Week 21, Week 42 and Week 68
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.
Change from Week 0, Week 8, Week 21, Week 42 and Week 68

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida International University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Miami
Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel M. Bagner, Ph.D., ABPP, Florida International University
  • Principal Investigator: Jonathan S. Comer, Ph.D., Florida International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-15-0134
  • R01HD084497 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

We will use a controlled access approach, using a robust system to review requests and provide secure access to de-identified data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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