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

Developmental Delay Clinical Trial

— ACCESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260816
• Other study ID #: IRB-15-0134
• Secondary ID: R01HD084497
• Status: Completed
• Phase: N/A
• Start date: March 16, 2016
• Est. completion date: December 21, 2020

Study information

• Verified date: June 2022
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 21, 2020
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Months to 60 Months

Eligibility

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)

Related Conditions & MeSH terms

• Developmental Delay
• Disruptive Behavior
• Problem Behavior

Intervention

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.

Other:
• Referrals as Usual (RAU)
Families assigned to RAU will participate in services referred by their Early Steps team, as per usual care.

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida
United States	University of Miami, Early Steps North	Miami	Florida
United States	Nicklaus Children's Hospital, Early Steps South	Palmetto Bay	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Florida International University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Nicklaus Children's Hospital f/k/a Miami Children's Hospital, University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (28)

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Wakschlag LS, Briggs-Gowan MJ, Choi SW, Nichols SR, Kestler J, Burns JL, Carter AS, Henry D. Advancing a multidimensional, developmental spectrum approach to preschool disruptive behavior. J Am Acad Child Adolesc Psychiatry. 2014 Jan;53(1):82-96.e3. doi: 10.1016/j.jaac.2013.10.011. Epub 2013 Nov 7. — View Citation

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Zimmerman, I.L., Steiner, V.G. and Pond, R.E., 2011, Preschool Language Scale, 5th Edition. (San Antonio, TX: The Psychological Corporation).

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline (Week 0), Post (Week 21), Follow-Up One (Week 42) and Follow-Up Two (Week 68)
Secondary	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.	Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Secondary	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.	Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Secondary	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.	Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Secondary	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.	Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Secondary	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.	Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Secondary	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.	Change from Week 0, Week 21, Week 42 and Week 68
Secondary	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.	Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Secondary	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.	Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Secondary	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.	Change from Week 0, Week 21, Week 42 and Week 68
Secondary	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.	Change from Week 0, Week 21, Week 42 and Week 68
Secondary	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.	Week 21
Secondary	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.	Change in weekly ratings from Week 0 to Week 21
Secondary	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.	Week 21
Secondary	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.	Week 21
Secondary	Telepresence in Videoconferencing Scale	The Telepresence in Videoconferencing Scale will be administered to assess caregiver experience interacting within video web-conferencing platform.	Week 21
Secondary	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.	Week 21
Secondary	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.	Baseline (Week 0)
Secondary	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.	Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Secondary	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.	Change from Week 0, Week 8, Week 21, Week 42 and Week 68
Secondary	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.	Change from Week 0, Week 8, Week 21, Week 42 and Week 68

External Links

•   Study website targeted to potential study participants.