Early Intervention for Young Children At-Risk for ADHD: Evaluating Efficacy and Delivery Format for Behavioral Parent Education
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Mediators and Moderators (Parent): ADHD Symptoms
研究概览
简要总结
Parent education is an effective and relatively cost efficient approach for reducing child behavior problems. Research, however, suggests that the effectiveness of parent education is mitigated by parent attendance and parent implementation of intervention strategies. That is, low attendance at parent education sessions is associated with limited intervention effects. Therefore, it is critical to identify strategies to enhance parent engagement. A previous pilot randomized controlled trial of a parent education program (Behavioral Parent Education; BPE, specifically Promoting Engagement for ADHD pre-Kindergartners [PEAK]), found that both face-to-face (F2F) and online BPE resulted in high levels of parent engagement and child behavior improvements. However, results need to be replicated in a full scale efficacy trial with a larger, diverse sample to provide more reliable estimates of relative effect sizes for parent and child outcomes and to evaluate the extent to which parent and child behavior changes are maintained after BPE has ended. In the current randomized controlled trial, the investigators intend to apply What Works Clearinghouse group design standards to examine the efficacy of two forms of delivery of BPE (F2F and online) relative to a wait-list control condition in a sample of 180, 3- to 5-year old children with clinically significant symptoms of ADHD. The objective is to: (a) extend findings from the pilot investigation to a large, diverse sample; (b) examine maintenance of effects; (c) identify moderators and mediators of treatment outcome, especially the degree to which these may differ for F2F vs. online treatment delivery; and (d) assess cost and cost-effectiveness of the two PEAK delivery formats.
详细描述
PEAK addresses potential barriers to treatment access and engagement in at least four ways. First, the 10 sessions require fewer hours to complete relative to typical BPE programs. Second, PEAK content and process was developed with extensive input from primary stakeholders (i.e., parents of young children with ADHD). The iterative process used in the Development grant provided critical parental input regarding revision to maximize engagement. Third, the availability of online treatment delivery allows greater flexibility relative to F2F delivery in terms of time and location of completing BPE sessions. This should increase access for families with limited resources (e.g., transportation) or constrained schedules. Finally, online delivery may be less costly to access given need for fewer resources (e.g., space, child care), although relative cost-effectiveness will be explored in greater detail in the proposed project.
Intervention Components. Both the F2F and online versions of PEAK contain 10 scripted BPE sessions that last approximately 1.5 hours. Session content includes: 1) Introduction to ADHD, 2) Attending, Rewards and Ignoring, 3) General Behavior Management Strategies, 4) Problem-Solving Approach, 5) Preventive Intervention, 6) Instructive Interventions, 7) Response Strategies, 8) Extending What Works to Community Settings, 9) Promoting Early Reading and Math Skills, and 10) Effective Communication Strategies. Supplemental Optimism Training will also be included to help parents identify/improve pessimistic thoughts about their parenting and their child's behavior. Each session contains didactic instruction interspersed with activities designed to enhance parent engagement. Sessions include video examples and interactive activities, such as role-play, group discussion for F2F, and check-in questions for online. Weekly homework activities are assigned for strategy practice. For example, parents choose one strategy (e.g., transitional warning, timer, choice) discussed during the session to implement at home. At the start of the following session, the session leader checks in with families on the use of the chosen strategy. The session leader praises successes and troubleshoots where strategy implementation went awry, suggesting alternative strategies or implementation approaches.
For the online version of the program, parents are provided with password- protected individual access codes to the online PEAK program. Check-ins are provided weekly via each parent's preferred mode of communication (i.e., text, internet, phone) to query strategies implemented, praise success, and troubleshoot alternative strategies.
Both the F2F and online versions of PEAK address many of the inner and outer contextual variables, particularly those that are malleable. For example, streamlined and/or online BPE may ease access challenges related to single parent status, inflexible treatment hours/location, or perceived stigma associated with obtaining mental health treatment. Program content is designed to enhance perceived sense of parenting efficacy through ongoing feedback from PEAK staff regarding use of strategies. Similarly, content is designed to provide parents with accurate attributions for child behavior difficulties in the context of understanding ADHD as well as environmental factors impacting behavior (e.g., antecedents, consequences). PEAK also includes content designed to help parents communicate and collaborate with teachers and school personnel.
Process and Materials. The F2F program is fully manualized, with each session consisting of slides, scripted presentation notes, and activities. Advanced graduate students in School Psychology or Special Education who have completed courses in Consultation and Positive Behavior Support serve as Session Leaders. To assure high quality delivery, the Principal Investigator (PI) or co-PI attends the first session and provides feedback to the Session Leader. All sessions are audiorecorded and the PI or co-PI listens to each recorded session weekly and completes a fidelity checklist. Weekly feedback is provided to the Session Leader regarding strengths and areas for improvement.
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)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •3- to 5.11-year old children with clinically significant symptoms of ADHD.
- •Children had to have met DSM-5 criteria for one of the three presentations of ADHD based on clinical interview and parent and teacher behavior ratings, including parent and teacher report of elevated levels of impairment at home and school (i.e., score greater than 90th percentile on one or more Conners Early Childhood Rating Scale subscales relevant to ADHD).
排除标准
- •A diagnoses of autism spectrum disorder (ASD), pervasive developmental disorder, intellectual disability, neurological damage, or significant motor or physical impairments.
- •Children needed to be enrolled in a pre-school or day care setting at least 2 days a week unless otherwise unable to enroll (e.g. behavioral problems, lack of services for unrelated disability) in order to establish the presence of symptoms across two settings.
结局指标
主要结局
Mediators and Moderators (Parent): ADHD Symptoms
时间窗: 2 years
Parent ADHD symptoms will be assessed using the Adult Investigator Symptom Rating Scale (R=18-90; higher scores= worse outcomes).
Post-Treatment Effects (Parent): Intervention Strategies
时间窗: 10 weeks
To assess changes in intervention strategy use the test of parent knowledge (R= 0-15) and parent fidelity (R= 0-9) form will be used (higher scores = better outcomes).
Post-Treatment Effects (Parent): Behavior
时间窗: 10 weeks
To assess changes in parent behavior the Parenting Young Children (R= 22-154; higher scores = better outcomes), the DPICS and RPC (higher scores on negative codes = worse outcomes and higher scores on positive codes = better outcomes)
Post-Treatment Effects (Parent): Acceptability
时间窗: 10 weeks
To assess treatment acceptability the Intervention rating profile-15 (R= 15-90; higher scores = better outcomes) will be used.
Post-Treatment Effects (Parent): Stress
时间窗: 10 weeks
To assess chases in parenting stress, The Parenting Stress Inventory-4 (R=36-180; higher scores = worse outcomes) will be used.
Post-Treatment Effects (Child): Bedtime Behaviors
时间窗: 10 weeks
To examine changes in child bedtime behaviors behaviors the Children's Sleep-Wake Scale-GTBS (R=5-30; higher scores indicate better outcomes).
Maintenance (Child): Behavior Observations
时间窗: 2 years
To examine maintenance in child behavior the Dyadic Parent-Child Interactive Coding System-Revised (DPICS) and Relationship Process Code-2 (RPC) (higher scores on negative codes = worse outcomes and higher scores on positive codes = better outcomes)
Maintenance (Child): Self Regulation
时间窗: 2 years
To examine maintenance in child self-regulation, the Head-Toes-Knees-Shoulders-Task (R=0-16; higher scores indicate better outcomes)
Maintenance (Parent): Behavior
时间窗: 2 years
To assess maintenance in parent behavior the Parenting Young Children (R= 22-154; higher scores = better outcomes), the DPICS and RPC (higher scores on negative codes = worse outcomes and higher scores on positive codes = better outcomes)
Cost-Effectiveness (money): Face-to-face
时间窗: 5 years
Investigators will determine costs of the F2F program using the ingredients method by documenting cost of: (a) session leader, based on required minimal qualifications and salary for position ($); (b) space to run sessions ($ to rent out space) (d) food provided during session ($ for cost of food); (c) childcare provided during session ($ for childcare per hour); and (d) transportation, calculated by number of families needing transportation divided by total number of families (multiplied by average miles round trip x average Uber fare). Investigators will review effectiveness metrics by stratifying participants based on their characteristics (parent education level, socioeconomic index, ADHD medication status) prior to the intervention. Investigators will compare cost against effectiveness using Incremental Cost-Effectiveness Ratio (ICER).
Post-Treatment Effects (Parent): Optimism
时间窗: 10 weeks
To examine parental optimism post-treatment group comparisons, the Parental Attribution Measure (R= 0-12; higher scores = worse outcomes); The Family Empowerment Scale-Competence (R= 8-40; higher scores = better outcomes), and the Questionnaire on Resources and Stress-Pessimism (R=0-11; higher scores = worse outcomes) will be used.
Post-Treatment Effects (Child): Academics
时间窗: 10 weeks
To assess changes in child early academic skills the Individual Growth and Development Indicators of Early Learning (R=2.16-36.61; higher scores indicate better outcomes) will be used.
Post-Treatment Effects (Child): Behavior
时间窗: 10 weeks
To examine changes in child behavior the Conners-EC Rating Scale (R=0-100, higher scores indicate worse outcomes except for the developmental milestones)
Mediators and Moderators (Child)
时间窗: 2 years
To assess child self regulation the Head-Toes-Knees-Shoulders-Task (HTSK) will be used (R=0-16; higher scores indicate better outcomes).
Post-Treatment Effects (Child): Self Regulation
时间窗: 10 weeks
To examine changes in child self-regulation, the Head-Toes-Knees-Shoulders-Task (R=0-16; higher scores indicate better outcomes)
Maintenance (Parent): Acceptability
时间窗: 2 years
To assess maintenance of treatment acceptability the Intervention rating profile-15 (R= 15-90; higher scores = better outcomes) will be used.
Maintenance (Parent): Intervention Strategies
时间窗: 2 years
To assess maintenance in intervention strategy use the test of parent knowledge (R= 0-15) and parent fidelity (R= 0-9) form will be used (higher scores = better outcomes).
Maintenance (Child): Bedtime Behaviors
时间窗: 2 years
To examine maintenance in child bedtime behaviors behaviors the Children's Sleep-Wake Scale-GTBS (R=5-30; higher scores indicate better outcomes).
Mediators and Moderators (Parent): Session Completion
时间窗: 2 years
To examine parent session completion, a frequency count will be used (higher scores= better outcomes).
Mediators and Moderators (Parent): Demographics
时间窗: 2 years
To assess parent income, education, and marital status the Parent Demographic Information form will be used.
Mediators and Moderators (Parent): Parent Strategies
时间窗: 2 years
The test of parent knowledge (R= 0-15) and fidelity checklist (R= 0-9) (higher scores = better outcomes) will be used.
Mediators and Moderators (Parent): Stress
时间窗: 2 years
To assess parent stress, the Parenting Stress Inventory (PSI) will be used (R=36-180; higher scores = worse outcomes).
Post-Treatment Effects (Child): Behavior Observations
时间窗: 10 weeks
To examine changes in child behavior the Dyadic Parent-Child Interactive Coding System-Revised (DPICS) and Relationship Process Code-2 (RPC) (higher scores on negative codes = worse outcomes and higher scores on positive codes = better outcomes)
Post-Treatment Effects (Child): Social Behaviors
时间窗: 2 years
To assess maintenance in child social behaviors the Adaptive Social Behavior Inventory (R=30-90; higher scores indicate worse outcomes) will be used
Maintenance (Parent): Stress
时间窗: 2 years
To assess maintenance in parenting stress, The Parenting Stress Inventory-4 (R=36-180; higher scores = worse outcomes) will be used.
Maintenance (Parent): Optimism
时间窗: 2 years
To examine maintenance in parental optimism, the Parental Attribution Measure (R= 0-12; higher scores = worse outcomes), The Family Empowerment Scale-Competence (R= 8-40; higher scores = better outcomes), and the Questionnaire on Resources and Stress-Pessimism (R=0-11; higher scores = worse outcomes) will be used.
Mediators and Moderators (Parent): Media
时间窗: 2 years
Parent media use preference the Media and Technology Usage and Attitudes Scale (MTUAS) (R=45-506; higher scores = better outcomes) will be used.
Cost-Effectiveness (time): Face-to-face
时间窗: 5 years
Investigators will determine costs of the F2F program using the ingredients method by documenting time of: Individual contact hours by provider with minimal qualifications to support families between sessions (calculated as minutes of contact across efficacy trial divided by number of families). Investigators will review effectiveness metrics by stratifying participants based on their characteristics (parent education level, socioeconomic index, ADHD medication status) prior to the intervention. Investigators will compare cost against effectiveness using Incremental Cost-Effectiveness Ratio (ICER).
Cost-Effectiveness (time): Online
时间窗: 5 years
For the online program, we will determine costs (in time) of (a) individual contact hours by provider with minimal qualifications to support families between sessions, calculated as minutes of contact across efficacy trial divided by number of families; (b) technology support for families, as provided by technology expert with minimal qualifications and calculated as minutes spent supporting families with user challenges divided by total number of families in efficacy trial; and (c) technology support on creator end, as provided by technology expert with minimal qualifications and calculated as minutes spent. Investigators will review effectiveness metrics by stratifying participants based on their characteristics (parent education level, socioeconomic index, ADHD medication status) prior to the intervention. Investigators will compare cost against effectiveness using Incremental Cost-Effectiveness Ratio (ICER).
Cost-Effectiveness (money): Online
时间窗: 5 years
For the online program, we will determine costs of purchase of phone and data plan for approximately 10% of families without internet access. Investigators will review effectiveness metrics by stratifying participants based on their characteristics (parent education level, socioeconomic index, ADHD medication status) prior to the intervention. Investigators will compare cost against effectiveness using Incremental Cost-Effectiveness Ratio (ICER).
次要结局
未报告次要终点
研究者
George DuPaul
Associate Dean for Research; Professor of School Psychology
Lehigh University