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

Florida International University (FIU)

Status: Completed

Conditions: Disruptive Behavior; Developmental Delay

Treatments: Other: Referrals as Usual (RAU); Behavioral: Internet-delivered Parent-Child Interaction Therapy (I-PCIT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03260816

IRB-15-0134

R01HD084497 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 30 to 60 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Internet-Delivered Parent Training

Experimental group

Description:

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.

Treatment:

Behavioral: Internet-delivered Parent-Child Interaction Therapy (I-PCIT)

Referrals as Usual (RAU)

Active Comparator group

Description:

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.

Treatment:

Other: Referrals as Usual (RAU)