Developmental DelayACCESSNCT03260816

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

A study testing Internet-delivered Parent-Child Interaction Therapy (I-PCIT) and Referrals as Usual (RAU) in people with Developmental Delay and Disruptive Behavior, run by Florida International University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 60 months
Conditions the study is for: Developmental Delay, Disruptive Behavior
What is being tested?: Internet-delivered Parent-Child Interaction Therapy (I-PCIT) and Referrals as Usual (RAU)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 3 sitesUnited States
Study dates: 16 Mar 2016to 21 Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 60 months
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

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.

Read the 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.

Conditions: Developmental Delay, Disruptive Behavior
Being tested: Internet-delivered Parent-Child Interaction Therapy (I-PCIT), Referrals as Usual (RAU)
Keywords: Preschoolers, Developmental Delay, Disruptive Behavior, Early Intervention, Parent-Child Interaction Therapy (PCIT), Telehealth, Telemental Health, Telepsychiatry
Medical subject headings: Learning Disabilities, Problem Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Internet-delivered Parent-Child Interaction Therapy (I-PCIT)Behavioural
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.
Referrals as Usual (RAU)Other
Families assigned to RAU will participate in services referred by their Early Steps team, as per usual care.

Study groups in NCT03260816
Study group	Role	What they receive
Internet-Delivered Parent Training	Experimental	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. Receives: Behavioral: Internet-delivered Parent-Child Interaction Therapy (I-PCIT)
Referrals as Usual (RAU)	Active comparator	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. Receives: Other: Referrals as Usual (RAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

Child Behavior Checklist, Ages 1.5-5 (CBCL, 1.5-5)
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.
Measured: Change from Week 0, Week 8, Week 21, Week 42 and Week 68

Secondary outcomes (21)

Body Mass Index (BMI)
A weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters.
Measured: Baseline (Week 0), Post (Week 21), Follow-Up One (Week 42) and Follow-Up Two (Week 68)
Sutter-Eyberg Behavior Inventory, Revised (SESBI-R)
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.
Measured: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Multidimensional Assessment of Preschool Disruptive Behavior (MAP-DB): Temper Loss Scale
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.
Measured: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Impossibly Perfect Circle (IPC)
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.
Measured: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Child Rearing Inventory (CRI)
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.
Measured: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Parenting Practices Inventory (PPI)
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.
Measured: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Parent-Child Book Reading
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.
Measured: Change from Week 0, Week 21, Week 42 and Week 68
Family Impact Questionnaire (FIQ)
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.
Measured: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Depression, Anxiety, Stress Scale- 21 (DASS-21)
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.
Measured: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Bracken School Readiness Assessment-3 (BSRA-3)
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.
Measured: Change from Week 0, Week 21, Week 42 and Week 68
Preschool Language Scale-5 (PLS-5)
The Preschool Language Scale-5 (PLS-5; Zimmerman, Steiner, \& Pond, 2011) is an assessment of developmental language skills, specifically auditory comprehension and expressive communication.
Measured: Change from Week 0, Week 21, Week 42 and Week 68
Clinical Global Impression (CGI-I)
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.
Measured: Week 21
Technology Experience and Attitude Rating Scale (TEARS)
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.
Measured: Change in weekly ratings from Week 0 to Week 21
Therapy Attitude Inventory (TAI)
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.
Measured: Week 21
Client Satisfaction Questionnaire-8 (CSQ-8)
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.
Measured: Week 21
Telepresence in Videoconferencing Scale
The Telepresence in Videoconferencing Scale will be administered to assess caregiver experience interacting within video web-conferencing platform.
Measured: Week 21
Barriers to Treatment Participation Scale (BTPS)
The Barriers to Treatment Participation Scale (BTPS; Kazdin et al. 1997) is a 44-item measure of perceived barriers to treatment participation.
Measured: Week 21
Parental Attitudes Toward Psychological Services Inventory (PATPSI): Stigmatization Scale and Help-Seeking Attitudes Scale
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.
Measured: Baseline (Week 0)
Child's Sleep Habits Questionnaire
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.
Measured: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Dyadic Parent-Child Interaction Coding System-IV (DPICS-4)
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.
Measured: Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Eyberg Child Behavior Inventory (ECBI)
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.
Measured: Change from Week 0, Week 8, Week 21, Week 42 and Week 68

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 201621 Dec 2020

First posted24 Aug 2017
Study start16 Mar 2016
Primary completion21 Dec 2020
Study completion21 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (31)Papers the sponsor has linked to this study.
Other trials for Developmental DelayStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03260816
Sponsor's protocol ID: IRB-15-0134
Other IDs: R01HD084497
Acronym: ACCESS
Status last verified: Jun 2022
First submitted: 17 Aug 2017
Last updated: 3 Jun 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: We will use a controlled access approach, using a robust system to review requests and provide secure access to de-identified data.

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.
Myers K, Cain S; Work Group on Quality Issues; American Academy of Child and Adolescent Psychiatry Staff. Practice parameter for telepsychiatry with children and adolescents. J Am Acad Child Adolesc Psychiatry. 2008 Dec;47(12):1468-83. doi: 10.1097/CHI.0b013e31818b4e13.
PubMed 19034191
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.
Donenberg G, Baker BL. The impact of young children with externalizing behaviors on their families. J Abnorm Child Psychol. 1993 Apr;21(2):179-98. doi: 10.1007/BF00911315.
PubMed 8491931
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.
Jensen PS, Eaton Hoagwood K, Roper M, Arnold LE, Odbert C, Crowe M, Molina BS, Hechtman L, Hinshaw SP, Hoza B, Newcorn J, Swanson J, Wells K. The services for children and adolescents-parent interview: development and performance characteristics. J Am Acad Child Adolesc Psychiatry. 2004 Nov;43(11):1334-44. doi: 10.1097/01.chi.0000139557.16830.4e.
PubMed 15502592

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Developmental Delays

All Developmental Delay trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Advancing Child Competencies by Extending Supported Services (ACCESS) for Families Program
ClinicalTrials.gov ID: NCT03260816
Acronym / sponsor ID: ACCESS / IRB-15-0134
Conditions: Developmental Delay, Disruptive Behavior
Keywords: Preschoolers, Developmental Delay, Disruptive Behavior, Early Intervention, Parent-Child Interaction Therapy (PCIT), Telehealth, Telemental Health, Telepsychiatry
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Florida International UniversityUniversity, hospital or other
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)
Study start: 16 Mar 2016 (actual)
Primary completion: 21 Dec 2020 (actual)
Study completion: 21 Dec 2020 (actual)
First posted: 24 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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).

Arm	Type	Receives
Internet-Delivered Parent Training	Experimental	Behavioral: Internet-delivered Parent-Child Interaction Therapy (I-PCIT)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.
Referrals as Usual (RAU)	Active comparator	Other: 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.

Who may qualify

Ages: 30 to 60 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Internet-Delivered Parent Training
Referrals as Usual (RAU)Families assigned to RAU will participate in services referred by their Early Steps team, as per usual care.	Other	Referrals as Usual (RAU)

Primary outcome

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.

21 secondary outcomes

Body Mass Index (BMI)
Time frame: 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
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
Impossibly Perfect Circle (IPC)
Time frame: 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
Parenting Practices Inventory (PPI)
Time frame: 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
Family Impact Questionnaire (FIQ)
Time frame: 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
Bracken School Readiness Assessment-3 (BSRA-3)
Time frame: 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
Clinical Global Impression (CGI-I)
Time frame: Week 21
Technology Experience and Attitude Rating Scale (TEARS)
Time frame: Change in weekly ratings from Week 0 to Week 21
Therapy Attitude Inventory (TAI)
Time frame: Week 21
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: Week 21
Telepresence in Videoconferencing Scale
Time frame: Week 21
Barriers to Treatment Participation Scale (BTPS)
Time frame: Week 21
Parental Attitudes Toward Psychological Services Inventory (PATPSI): Stigmatization Scale and Help-Seeking Attitudes Scale
Time frame: Baseline (Week 0)
Child's Sleep Habits Questionnaire
Time frame: 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
Eyberg Child Behavior Inventory (ECBI)
Time frame: Change from Week 0, Week 8, Week 21, Week 42 and Week 68

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
BackgroundAchenbach, T. M., & Rescorla, L. A. (2001). Manual for the ASEBA Preschool Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
Background: PubMed 19034191Myers K, Cain S; Work Group on Quality Issues; American Academy of Child and Adolescent Psychiatry Staff. Practice parameter for telepsychiatry with children and adolescents. J Am Acad Child Adolesc Psychiatry. 2008 Dec;47(12):1468-83. doi: 10.1097/CHI.0b013e31818b4e13.
BackgroundBracken, B. A. (2007). Bracken School Readiness Assessment. San Antonio, TX: Psychological Corporation.
BackgroundBrestan , 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.
BackgroundBrestan, 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.
BackgroundCain, J. (2005). The Way I Feel. Chicago, IL: Parenting Press.
BackgroundCain, J. (2009). Asi Me Sientol. Chicago, IL: Parenting Press.
Background: PubMed 8491931Donenberg G, Baker BL. The impact of young children with externalizing behaviors on their families. J Abnorm Child Psychol. 1993 Apr;21(2):179-98. doi: 10.1007/BF00911315.
BackgroundEyberg, S. M., & Funderburk, B. W. (2011). Parent-Child Interaction Therapy Protocol. Gainesville, FL: PCIT International.
BackgroundEyberg, 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.
BackgroundEyberg, S. M., & Pincus, D. (1999). Eyberg Child Behavior Inventory and Sutter-Eyberg Student Behavior Inventory: Professional manual. Odessa, FL: Psychological Assessment Resources.
BackgroundGoldsmith, H.H., Reilly, J (1993). Laboratory Assessment of Temperament Preschool Version. University of Oregon.
Individual participant dataSharing planned: Undecided. 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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Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate Risk
Development Delay, Motor Skills Disorders
Recruiting
Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Developmental Delays
Developmental Delays

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel M. Bagner, Ph.D., ABPP principal investigator

Florida International University

Jonathan S. Comer, Ph.D. principal investigator

Florida International University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03260816, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.