Advancing Child Competencies by Extending Supported Services (ACCESS) for Families Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Child Behavior Checklist, Ages 1.5-5 (CBCL, 1.5-5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Independent evaluators and coders assessing response over time are kept unaware of the condition to which each participant is assigned.
入排标准
- 年龄范围
- 30 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Internet-delivered Parent-Child Interaction Therapy (I-PCIT) (Behavioral)
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.
干预措施: Referrals as Usual (RAU) (Other)
结局指标
主要结局
Child Behavior Checklist, Ages 1.5-5 (CBCL, 1.5-5)
时间窗: 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.
次要结局
- Depression, Anxiety, Stress Scale- 21 (DASS-21)(Change from Week 0, Week 8, Week 21, Week 42 and Week 68)
- Parenting Practices Inventory (PPI)(Change from Week 0, Week 8, Week 21, Week 42 and Week 68)
- Body Mass Index (BMI)(Baseline (Week 0), Post (Week 21), Follow-Up One (Week 42) and Follow-Up Two (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)
- Family Impact Questionnaire (FIQ)(Change from Week 0, Week 8, Week 21, Week 42 and Week 68)
- Bracken School Readiness Assessment-3 (BSRA-3)(Change from Week 0, Week 21, Week 42 and Week 68)
- Therapy Attitude Inventory (TAI)(Week 21)
- Telepresence in Videoconferencing Scale(Week 21)
- Barriers to Treatment Participation Scale (BTPS)(Week 21)
- Parental Attitudes Toward Psychological Services Inventory (PATPSI): Stigmatization Scale and Help-Seeking Attitudes Scale(Baseline (Week 0))
- Child's Sleep Habits Questionnaire(Change from Week 0, Week 8, Week 21, Week 42 and Week 68)
- Sutter-Eyberg Behavior Inventory, Revised (SESBI-R)(Change from Week 0, Week 8, Week 21, Week 42 and Week 68)
- Parent-Child Book Reading(Change from Week 0, Week 21, Week 42 and Week 68)
- Clinical Global Impression (CGI-I)(Week 21)
- Technology Experience and Attitude Rating Scale (TEARS)(Change in weekly ratings from Week 0 to Week 21)
- Dyadic Parent-Child Interaction Coding System-IV (DPICS-4)(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)
- Preschool Language Scale-5 (PLS-5)(Change from Week 0, Week 21, Week 42 and Week 68)
- Client Satisfaction Questionnaire-8 (CSQ-8)(Week 21)
- Eyberg Child Behavior Inventory (ECBI)(Change from Week 0, Week 8, Week 21, Week 42 and Week 68)