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

NCT03260816 | Completed DMC

• 2 other identifiers: IRB-15-0134R01HD084497
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Developmental Delay; Disruptive Behavior

Keywords

Preschoolers; Developmental Delay; Disruptive Behavior; Early Intervention; Parent-Child Interaction Therapy (PCIT); Telehealth; Telemental Health; Telepsychiatry

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Week 0, Week 8, Week 21, Week 42 and Week 68

Secondary Outcomes (21)

• Body Mass Index (BMI)

  Baseline (Week 0), Post (Week 21), Follow-Up One (Week 42) and Follow-Up Two (Week 68)

• Sutter-Eyberg Behavior Inventory, Revised (SESBI-R)

  Change from Week 0, Week 8, Week 21, Week 42 and Week 68

• Multidimensional Assessment of Preschool Disruptive Behavior (MAP-DB): Temper Loss Scale

  Change from Week 0, Week 8, Week 21, Week 42 and Week 68

• Impossibly Perfect Circle (IPC)

  Change from Week 0, Week 8, Week 21, Week 42 and Week 68

• Child Rearing Inventory (CRI)

  Change from Week 0, Week 8, Week 21, Week 42 and Week 68

Study Arms (2)

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.

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.

Other: Referrals as Usual (RAU)

Interventions

Internet-delivered Parent-Child Interaction Therapy (I-PCIT) BEHAVIORAL

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.

Internet-Delivered Parent Training

Referrals as Usual (RAU) OTHER

Families assigned to RAU will participate in services referred by their Early Steps team, as per usual care.

Referrals as Usual (RAU)

Eligibility Criteria

• Age: 30 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Florida International University: lead
• University of Miami: collaborator
• Nicklaus Children's Hospital f/k/a Miami Children's Hospital: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

University of Miami, Early Steps North

Miami, Florida, 33136, United States

Location

Florida International University

Miami, Florida, 33199, United States

Location

Nicklaus Children's Hospital, Early Steps South

Palmetto Bay, Florida, 33157, United States

Location

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• Cafatti Mac-Niven A, Comer JS, Bagner DM. Predictors of homework engagement in internet-delivered Parent-Child Interaction Therapy for children with developmental delay: what about acculturation and enculturation? Front Child Adolesc Psychiatry. 2025 Mar 12;4:1500742. doi: 10.3389/frcha.2025.1500742. eCollection 2025.

  PMID: 40143964 DERIVED

• Merrill SM, Hogan C, Bozack AK, Cardenas A, Comer JS, Bagner DM, Highlander A, Parent J. Telehealth Parenting Program and Salivary Epigenetic Biomarkers in Preschool Children With Developmental Delay: NIMHD Social Epigenomics Program. JAMA Netw Open. 2024 Jul 1;7(7):e2424815. doi: 10.1001/jamanetworkopen.2024.24815.

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• Bagner DM, Berkovits MD, Coxe S, Frech N, Garcia D, Golik A, Heflin BH, Heymann P, Javadi N, Sanchez AL, Wilson MK, Comer JS. Telehealth Treatment of Behavior Problems in Young Children With Developmental Delay: A Randomized Clinical Trial. JAMA Pediatr. 2023 Mar 1;177(3):231-239. doi: 10.1001/jamapediatrics.2022.5204.

  PMID: 36622653 DERIVED

Related Links

• Study website targeted to potential study participants.

MeSH Terms

Conditions

Learning Disabilities; Problem Behavior

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Daniel M. Bagner, Ph.D., ABPP

  Florida International University

  PRINCIPAL INVESTIGATOR

• Jonathan S. Comer, Ph.D.

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators and coders assessing response over time are kept unaware of the condition to which each participant is assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 24, 2017
• Study Start: March 16, 2016
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: June 3, 2022

Record last verified: 2022-06

Locations

US (3)