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临床试验/NCT05344378
NCT05344378已完成不适用

Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
151
试验地点
2
主要终点
Feasibility of Intervention Measure (FIM)

研究概览

简要总结

This project, Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement with Mental Health Services for Youth with Autism (ATTAIN NAV) is focused on adapting and implementing family navigation in primary care settings to help accelerate and facilitate engagement in mental health and community services for children with autism and their families.

详细描述

Efficient and effective access to and engagement with evidence-based mental health (MH) services for children with autism spectrum disorder (ASD) is critically needed but requires a tailored approach. This project is critical in establishing integrated and sustainable local capacity to provide evidence-based MH care for children (ages 4-16 years) with ASD+ (i.e., children with ASD and co-occurring psychiatric disorders). Specifically, the overarching goal of this mixed methods proposal is to collaboratively adapt Family Navigation (FN) content, navigator activities and training for children with ASD+, identify and design technology enhancements to FN that will target key mechanisms to impact implementation, service and clinical outcomes, key interrelated outcomes for implementation research. The research team will leverage existing partnerships with primary care practices and lay health worker organizations in San Diego County to establish a community-academic partnership that will guide adaptations to FN for children with ASD+ (Aim 1), co-design of the navigator-facing technology enhancements (Aim 2) and trial the adapted and technology-enhanced FN (Aim 3).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
4 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria for Primary Care Providers
  • Employed as staff at participating primary care practice
  • Experience providing primary care to children with ASD
  • For Aim 3 only: Has at least five eligible children on current caseload
  • Inclusion Criteria for Child/Caregiver Participants (Aim 3 only)
  • Child age 4-16 years.
  • Child has a diagnosis of autism spectrum disorder documented in medical chart.
  • Child is receiving primary care at a participating primary care practice.
  • Child screens in the clinically significant range on the Pediatric Symptom Checklist at baseline.
  • Speaks English or Spanish.
  • Caregiver of an eligible child.

排除标准

  • 未提供

研究组 & 干预措施

1 Month Baseline Period

No Intervention

Initial baseline period for rollout at 6 different clinics throughout the year-long intervention period using a step-wedge design.

Stage 1 Enrollment

Experimental

Enrollment of 2 clinics over 4 months including 5 PCPs per clinic (2 total clinics).

干预措施: ATTAIN NAV Technology-Enhanced Family Navigation Model (Behavioral)

Stage 2 Enrollment

Experimental

Addition of 2 clinics with modifications over 4 months including 5 PCPs per clinic (4 total clinics).

干预措施: ATTAIN NAV Technology-Enhanced Family Navigation Model (Behavioral)

Stage 3 Enrollment

Experimental

Addition of 2 clinics with modifications over 4 months including 5 PCPs per clinic (4 total clinics).

干预措施: ATTAIN NAV Technology-Enhanced Family Navigation Model (Behavioral)

结局指标

主要结局

Feasibility of Intervention Measure (FIM)

时间窗: Distributed at study completion, an average of 1 year.

4-item questionnaire measure adapted for the ATTAIN NAV study to assess feasibility of the overall adapted FN intervention. Four-item measures of implementation outcomes that are considered indicators of implementation success. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Higher scores indicate a better outcome.

Appropriateness of Intervention Measure (AIM)

时间窗: Distributed at study completion, an average of 1 year.

4-item questionnaire measure adapted for the ATTAIN NAV study to assess appropriateness of the overall adapted FN intervention. Four-item measures of implementation outcomes that are considered indicators of implementation success. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Higher scores indicate a better outcome.

the Navigation Satisfaction Tool (NAVSAT)

时间窗: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.

22 item questionnaire assess satisfaction with the relationship with the navigator and with the referred services to which the navigator facilitated access. Response scale: 1= Extremely Dissatisfied 2=Dissatisfied 3=Fairly Dissatisfied 4= Not dissatisfied nor satisfied 5= Fairly Satisfied 6= Satisfied 7= Extremely Satisfied. Higher scores indicate a better outcome.

Acceptability of Intervention Measure (AIM)

时间窗: Distributed at study completion, an average of 1 year.

4-item questionnaire measure adapted for the ATTAIN NAV study to assess acceptability of the overall adapted FN intervention. Four-item measures of implementation outcomes that are considered indicators of implementation success. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Higher scores indicate a better outcome.

Navigator Fidelity

时间窗: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.

The investigators will adapt fidelity procedures (observational and self-report) from the navigator training curriculum used in MOST. Fidelity will be defined as demonstrating mastery on at least 80% of all components (e.g., navigator introduces purpose of navigation during initial contact, conducts assessment on barriers to attendance of first MH appointment). Fidelity will be measured at the completion of the navigator protocol for each family.

Eyberg Child Behavior Inventory (ECBI)

时间窗: Measured at the start and completion of family navigation services for each family, approximately week 0 and 4 months after enrolling.

The ECBI is a 36-item caregiver-report measure that assesses the frequency and intensity of child behavior problems. It has shown sensitivity to change over time. There are two scores: an Intensity score (frequency of behaviors) and a Problem (number of challenging behaviors) score. Both are converted into t-scores (M =50; SD=10). Scoring: on a 1-7 scale: How often does this occur with your child? ranging from (1) Never to (7) Always. There is a secondary scale that asks is this a problem for you? Yes/No.

Parent Activation Measure for Developmental Disabilities (PAM-DD)

时间窗: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.

This 13-item measure will be used to examine changes in caregiver knowledge, skill and confidence to manage their child. The PAM-DD also includes a rating scale of perceived caregiver activation level. The scale ranges from (1) strongly disagree to (4) strongly agree. A higher score indicates a more positive rating.

Parent Participation Engagement Measure

时间窗: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.

A 5-item parent-report measure of active caregiver engagement in youth mental health services. Each item assesses the frequency that a parent engaged in a participation behavior (e.g., asked questions, provided input, agreed with the plan) during a MH appointment on a 5-point scale ranging from (1) Not at all to (5) very much. To additionally capture family engagement, the investigators will track the number of contacts between the navigator and family during the interval between the PCP referral to navigation and the first completed MH appointment.

Eyberg Child Behavior Inventory (ECBI)

时间窗: Measured at the start (~Week 0) and completion (~Month 4) of family navigation services for each dyad.

The ECBI 36-item caregiver-report measure that assesses parent perceptions of frequency/severity of problem behaviors in their children/adolescent. There are two scales: 1. Intensity Scale: Measures the frequency behaviors reportedly occur. Items query "How often does X problem occur with your child? Responses rated on Likert scale from "(1) Never" to "(7) Always." Scoring: Responses to all 36 questions were added to derive the Raw intensity score (min.= 36, max.= 252). Cut-off for clinical significance: \>/= 131. 2. Problem Scale: Secondary scale that measures degree to which behavior is problematic. Parents prompted to answer "Is this a problem for you?" with "(1) yes" or "(0) no." Scoring: Total "Yes" responses for the 36 items were added derive the Raw problem score (min.=0, max=36). Cut-off for clinical significance: \>\\= 15. Because scores are weighted, higher scores that exceed identified clinical cutoffs reflect greater concern about the child's behaviors.

Parent Activation Measure for Developmental Disabilities (PAM-DD)

时间窗: Measure was completed by caregivers at baseline and post.

The Parent Activation Measures for Developmental Disabilities (PAM-DD) is 13-item measure used to examine changes in caregiver knowledge, skill and confidence to manage their child. The first subscale includes items related to the motivation and ability to actively intervene for one's child (e.g., ability to reduce problems, handle services, implement home treatments, understand behavior causes, use available treatments, implement recommendations, prevent problems, figure out solutions, and maintain changes). The second subscale contains items related to parental knowledge, cooperation, and agreement with treatment (e.g., responsibility for child's behavior, participation with treatment role). Respondents rate each item from (1) strongly disagree to (4) strongly agree. A higher score indicates a more positive rating (i.e., greater parent activation). Scores below reflect averages across items for each subscale (1 - 4) at baseline and post.

Parent Participation Engagement Measure (PPEM)

时间窗: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.

The PPEM is a 5-item parent-report measure of active caregiver engagement in youth mental health services (Haine-Schlagel et al., 2016). Each item assesses the frequency that a parent engaged in a participation behavior (e.g., asked questions, provided input, agreed with the plan) during a MH appointment. Items are rated on a 5-point scale ranging from (1) Not at all to (5) very much.

Parent Participant Engagement: Number of Contacts

时间窗: Contacts measured per dyad from referral to family navigation services (Baseline) to conclusion of study participation. (Approximately 4 months).

To additionally capture family engagement, the number of contact attempts (e.g., navigation sessions, texts, voicemail messages) between the navigator and each family during the interval between PCP referral to ATTAIN NAV (wherein a dyad was enrolled in family navigation following observation period) and the conclusion of ATTAIN NAV (end of a dyad's study participation) was calculated. These data were abstracted from the family navigation contact logs and include unsuccessful attempts.

Navigator Fidelity

时间窗: Navigators provided fidelity ratings for dyads at three points: (1) First session (Baseline), (2) Follow-up session at midpoint of family navigation (Approx. Month 2), and (3) Final session (Approx. Month 4).

Navigator fidelity was assessed using fidelity procedures (observational and self-report) from the navigator training curriculum used in previous autism-specific family navigation studies (Broder-Fingert et al., 2019, 2020). Navigators provided self-report fidelity ratings at three time-points: the Family Plan Development session (first navigation session), a follow-up session at the midpoint of family navigation, and the final session. Range: 0% - 100% "Fidelity" was defined as demonstrating mastery on at least 80% of components (e.g., navigator introduces purpose of navigation during initial contact, conducts assessment of barriers to attendance of first mental health appointment). A mean fidelity rating across the three sessions was computed for each family at post. Overall average for both conditions is reported here.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicole Stadnick

Associate Professor

University of California, San Diego

研究点 (2)

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