Child Development DisorderNCT04562038
Implementation of Electronic Shared Decision-Making Support for Early Intervention
A study testing Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO) in people with Child Development Disorder and Development Delay, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Family-centered care is a best practice approach to delivering high quality early intervention (EI) services for children 0-3 years old with developmental needs. Yet, family engagement in designing and monitoring their child's EI service plan is suboptimal. Read more about this study
- Who is it for?
- Ages 3 to 36 months
- Conditions the study is for
- Child Development Disorder, Development Delay
- What is being tested?
- Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Caregiver identifies as a parent or legal guardian of a child enrolled in early intervention
- Caregiver is at least 18 years old
- Caregiver reads, writes, and speaks English
- Caregiver has internet and telephone access
- Caregiver has a child who has received early intervention services for 3 or more months
Who cannot join
- Caregiver is not the parent or legal guardian of a child enrolled in early intervention
- Caregiver is 0-17 years old
- Caregiver does not read, write, or speak English
- Caregiver does not have internet or telephone access
- Caregiver does not have a child who has received early intervention services for 3 or more months
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Human Services
Denver, Colorado, 80231
About this study
Official title: Implementation of Electronic Shared Decision-Making Support for Families to Design and Monitor Participation-Focused Early Intervention
Family-centered care is a best practice approach to delivering high quality early intervention (EI) services for children 0-3 years old with developmental needs. Yet, family engagement in designing and monitoring their child's EI service plan is suboptimal. Families need a valid, reliable, and useful tool to share in decisions about the scope of their child's EI service plan. The investigators will achieve a major advance in contributing occupational therapy expertise to improve family engagement when designing and monitoring their child's EI services. The investigators will test the use of an evidence-based electronic tool with families at one EI program, when the child is due for an annual review of progress in the program. The investigators will also gather input from families, practitioners, and program leadership to identify facilitators and barriers to its use in multiple EI programs. This project tries to test an innovation in how the investigators deliver family-centered and participation-focused care. Study results will yield evidence for the effectiveness of the electronic intervention on parent activation, EI service plan focus, EI service use quantity, parent perceptions of EI service quality, and child functioning.
Read the detailed description
Poor quality of care in early intervention (EI) is pervasive, particularly for vulnerable populations. Sub-optimal outcomes are perpetuated within this federally-funded, state administrated program due to significant cuts in federal per child appropriations. Optimizing EI outcomes will require ensuring the delivery of high value EI (i.e., providing services with the greatest reach, optimal outcomes, at the lowest cost). A lever to improve value-based EI is family-centered care, an evidence-based EI approach, which is grounded in family engagement and shared decision-making. Regrettably, the systematic implementation of strategies to empower families in this role are suboptimal, perpetuating poor outcomes and the failure of family-centered care. More than half of all EI enrolled families lack sufficient tools to engage in shared decision-making with EI practitioners when designing and monitoring the EI service plan. Therefore, if EI service quality and outcomes are going to be optimized, there is urgent need to equip families with a tool that will foster shared decision-making between the provider and family.
As EI programs transition to electronic data capture systems for accountability and quality improvement, the implementation of evidence-based electronic assessments is a scalable strategy to strengthen family engagement in shared decision-making to design and monitor EI services. One evidence-based option is the Young Children's Participation in Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO). The YC-PEM e-PRO has not been implemented into routine practice for families to communicate areas of participation difficulty for shared decision-making about intervention priorities.
The first aim is to conduct a community-based pragmatic trial of the Young Children's Participation and Environment Measure (YC-PEM), a valid electronic patient-reported outcome (e-PRO), at a single large, urban EI program to examine how this intervention is associated with: 1) EI service use breadth, intensity, and focus, 2) parent activation for shared decision making and engagement in EI services, 3) parent-reported EI service quality, and 3) gains in children's functioning.
EI service coordinators will be randomized to intervention and control groups arms, and then eligible and interested parents on their assigned caseloads will be assigned to the intervention and control groups as part of their child's annual evaluation of progress. Intervention group subjects will complete the YC-PEM e-PRO before the child's annual intervention planning meeting. EI service plan focus (participation-focused goals in the plan), EI service amount (breadth and intensity), EI service quality (parent-reported activation for shared decision-making to design EI services and parent satisfaction with family-centeredness of EI service delivery), and child functioning will be evaluated via electronic records and patient-reported outcomes data collected at baseline, and 4 weeks, 6 months, and 12 months.
AIM 1. Examine the effects of the YC-PEM e-PRO intervention on EI stakeholder outcomes.
(Aim 1a). Examine the effects of the YC-PEM e-PRO on EI parent activation, parent engagement in EI services, service plan focus, and service use breadth and intensity. The investigators will test two hypotheses in this first sub-aim. As compared to children receiving usual EI care, intervention group subjects will: H1: report higher activation for shared decision-making and parent engagement when planning and monitoring the child's EI care within 12 months; H2: receive a greater breadth and intensity of participation-focused EI services within 12 months.
(Aim 1b). Examine the effects of the YC-PEM e-PRO on parent report of EI service quality. As compared to usual care subjects, the investigators expect that parents in the intervention group will report greater satisfaction with: H1: enabling and partnership; H2: general and specific information exchange for shared decision-making; H3: coordinated and comprehensive EI care; and H4: respectful and supportive EI care.
(Aim 1c). Examine the effects of the YC-PEM e-PRO on child functioning. As compared to usual EI care, intervention group children will: H1: demonstrate greater developmental gains, as measured by state-mandated and norm-referenced developmental tests done at EI entry and 12 months. H2: demonstrate greater gains in functional skills, as measured by state-mandated outcomes data at EI entry and 12 months.
- Conditions
- Child Development Disorder, Development Delay
- Being tested
- Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)
- Keywords
- early intervention, participation, shared decision-making, electronic, family-centered care
- Medical subject headings
- Developmental Disabilities, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)Behavioural
The Young Children's Participation in Environment Measure (YC-PEM) is an evidence-based option for comprehensive proxy assessment of a young child's current and desired participation in occupations across home, daycare, and community settings. The YC-PEM is an electronic patient-reported outcome (e-PRO) that provides individual caregivers a valid, reliable, and feasible way to communicate information about their child's current participation in home and community activities and areas of participation need. The gained information is then summarized and shared with the child's EI provide team to identify intervention priorities and goal attainment strategies in partnership with families. For quality improvement, EI programs can aggregate the YC-PEM e-PRO data to examine trends in participation as a function of EI service use. It is therefore a promising electronic health systems intervention to enhance the parent-practitioner relationship, and an NIH common data element for trials.
| Study group | Role | What they receive |
|---|---|---|
| YC-PEM e-PRO | Experimental | Participants are administered an electronic patient-reported outcome measure to obtain information about parent priorities, and they obtain a summary report of their responses to share with their early intervention team for discussion during the annual IFSP meeting. Receives: Behavioral: Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO) |
| Family Assessment | No intervention | Participants are scheduled to complete a semi-structured family interview to obtain information about parent priorities, for use during the annual IFSP meeting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Processes of Care (MPOC-20)
Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.
Measured: Baseline (pre-intervention)
Measure of Processes of Care (MPOC-20)
Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.
Measured: 4 weeks
Measure of Processes of Care (MPOC-20)
Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.
Measured: 6 months
Measure of Processes of Care (MPOC-20)
Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.
Measured: 12 months
Secondary outcomes (13)
Parent Patient Activation Measure (P-PAM)
Parent activation for shared decision-making; 13 items assesses parent knowledge, skills, and confidence to manage their child's care
Measured: Baseline (pre-intervention)
Parent Patient Activation Measure (P-PAM)
Parent activation for shared decision-making; 13 items assesses parent knowledge, skills, and confidence to manage their child's care
Measured: 4 weeks
Parent Patient Activation Measure (P-PAM)
Parent activation for shared decision-making; 13 items assesses parent knowledge, skills, and confidence to manage their child's care
Measured: 6 months
Parent Patient Activation Measure (P-PAM)
Parent activation for shared decision-making; 13 items assesses parent knowledge, skills, and confidence to manage their child's care
Measured: 12 months
Parent Participation Engagement measure (PPEM)
Parent engagement in EI services; 5 items (5-point scale) assesses parent active engagement in their child's EI services
Measured: Baseline (pre-intervention)
Parent Participation Engagement measure (PPEM)
Parent engagement in EI services; 5 items (5-point scale) assesses parent active engagement in their child's EI services
Measured: 4 weeks
Parent Participation Engagement measure (PPEM)
Parent engagement in EI services; 5 items (5-point scale) assesses parent active engagement in their child's EI services
Measured: 6 months
Parent Participation Engagement measure (PPEM)
Parent engagement in EI services; 5 items (5-point scale) assesses parent active engagement in their child's EI services
Measured: 12 months
Early Intervention Service Use Quantity
EI service use quantity will be captured according to service breadth and intensity. EI service breadth will be derived as a count of core EI services received (1, 2, 3+): physical therapy (PT), occupational therapy (OT), speech therapy (ST), developmental intervention (DI). For service intensity, estimates of service amount (hours) and service duration (months) from the service record will be used to derive an estimate of service use intensity (hours per month).
Measured: 1 month
Early Intervention Service Use Quantity
EI service use quantity will be captured according to service breadth and intensity. EI service breadth will be derived as a count of core EI services received (1, 2, 3+): physical therapy (PT), occupational therapy (OT), speech therapy (ST), developmental intervention (DI). For service intensity, estimates of service amount (hours) and service duration (months) from the service record will be used to derive an estimate of service use intensity (hours per month).
Measured: 12 months
Early Intervention Service Plan Focus
Record abstraction will be used to extract data on the child's service plan focus (i.e., EI service goals). These data will be coded using established quality criteria, to derive an estimate of the proportion of participation-focused goals in the EI service plan.
Measured: 4 weeks
Child Functioning
Child Outcomes Summary (COS) scores that capture the child's functional capabilities. COS scores are a consensus rating by the EI team based on developmental scores and practitioner and parent perceptions of child function.
Measured: Baseline (pre-intervention)
Child Functioning
Child Outcomes Summary (COS) scores that capture the child's functional capabilities. COS scores are a consensus rating by the EI team based on developmental scores and practitioner and parent perceptions of child function.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child Development DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Rocky Mountain Human Services, University of Colorado, Denver, University of Pittsburgh
- Responsible party
- Principal investigator, Mary A Khetani, University of Illinois Chicago
- Investigators
- Mary A Khetani, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562038
- Sponsor's protocol ID
- 2020-0555
- Other IDs
- AOTFIR20KHETANI
- Status last verified
- Feb 2023
- First submitted
- 19 Jul 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bosak DL, Frame L, Bobitt J, Guillen C, Khetani MA. Refining implementation determinants and strategies to scale an electronic assessment option for coordinating family-centred care in early intervention. BMJ Paediatr Open. 2026 May 25;10(1):e003801. doi: 10.1136/bmjpo-2025-003801.
PubMed 42185022Kaelin VC, Rizk S, Chen YF, Dooling-Litfin J, Lerner Papautsky E, Leland NE, Murphy NJ, McManus BM, Lage CR, Villegas V, Kuznicki L, Pedrow A, Khetani MA; High Value Early Intervention Research Group. Electronic Patient-Reported Outcome Measure and Decision Support Tool Option for Early Intervention Service Quality: A Pilot Cluster-Randomized Pragmatic Trial. Adv Rehabil Sci Pract. 2026 May 7;15:27536351261445239. doi: 10.1177/27536351261445239. eCollection 2026 Jan-Dec.
PubMed 42131290Kaelin V, Villegas V, Chen YF, Murphy N, Papautsky E, Litfin J, Leland N, Maheshwari V, McManus B, Khetani M; High Value Early Intervention Research Group. Effectiveness and scalability of an electronic patient-reported outcome measure and decision support tool for family-centred and participation-focused early intervention: PROSPECT hybrid type 1 trial protocol. BMJ Open. 2022 Jan 4;12(1):e051582. doi: 10.1136/bmjopen-2021-051582.
PubMed 34983760
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Electronic Shared Decision-Making Support for Families to Design and Monitor Participation-Focused Early Intervention
- ClinicalTrials.gov ID
- NCT04562038
- Acronym / sponsor ID
- 2020-0555
- Conditions
- Child Development Disorder, Development Delay
- Keywords
- early intervention, participation, shared decision-making, electronic, family-centered care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Rocky Mountain Human Services, University of Colorado, Denver, University of Pittsburgh
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Family-centered care is a best practice approach to delivering high quality early intervention (EI) services for children 0-3 years old with developmental needs. Yet, family engagement in designing and monitoring their child's EI service plan is suboptimal. Families need a valid, reliable, and useful tool to share in decisions about the scope of their child's EI service plan. The investigators will achieve a major advance in contributing occupational therapy expertise to improve family engagement when designing and monitoring their child's EI services. The investigators will test the use of an evidence-based electronic tool with families at one EI program, when the child is due for an annual review of progress in the program. The investigators will also gather input from families, practitioners, and program leadership to identify facilitators and barriers to its use in multiple EI programs. This project tries to test an innovation in how the investigators deliver family-centered and participation-focused care. Study results will yield evidence for the effectiveness of the electronic intervention on parent activation, EI service plan focus, EI service use quantity, parent perceptions of EI service quality, and child functioning.
Detailed description
Poor quality of care in early intervention (EI) is pervasive, particularly for vulnerable populations. Sub-optimal outcomes are perpetuated within this federally-funded, state administrated program due to significant cuts in federal per child appropriations. Optimizing EI outcomes will require ensuring the delivery of high value EI (i.e., providing services with the greatest reach, optimal outcomes, at the lowest cost). A lever to improve value-based EI is family-centered care, an evidence-based EI approach, which is grounded in family engagement and shared decision-making. Regrettably, the systematic implementation of strategies to empower families in this role are suboptimal, perpetuating poor outcomes and the failure of family-centered care. More than half of all EI enrolled families lack sufficient tools to engage in shared decision-making with EI practitioners when designing and monitoring the EI service plan. Therefore, if EI service quality and outcomes are going to be optimized, there is urgent need to equip families with a tool that will foster shared decision-making between the provider and family.
As EI programs transition to electronic data capture systems for accountability and quality improvement, the implementation of evidence-based electronic assessments is a scalable strategy to strengthen family engagement in shared decision-making to design and monitor EI services. One evidence-based option is the Young Children's Participation in Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO). The YC-PEM e-PRO has not been implemented into routine practice for families to communicate areas of participation difficulty for shared decision-making about intervention priorities.
The first aim is to conduct a community-based pragmatic trial of the Young Children's Participation and Environment Measure (YC-PEM), a valid electronic patient-reported outcome (e-PRO), at a single large, urban EI program to examine how this intervention is associated with: 1) EI service use breadth, intensity, and focus, 2) parent activation for shared decision making and engagement in EI services, 3) parent-reported EI service quality, and 3) gains in children's functioning.
EI service coordinators will be randomized to intervention and control groups arms, and then eligible and interested parents on their assigned caseloads will be assigned to the intervention and control groups as part of their child's annual evaluation of progress. Intervention group subjects will complete the YC-PEM e-PRO before the child's annual intervention planning meeting. EI service plan focus (participation-focused goals in the plan), EI service amount (breadth and intensity), EI service quality (parent-reported activation for shared decision-making to design EI services and parent satisfaction with family-centeredness of EI service delivery), and child functioning will be evaluated via electronic records and patient-reported outcomes data collected at baseline, and 4 weeks, 6 months, and 12 months.
AIM 1. Examine the effects of the YC-PEM e-PRO intervention on EI stakeholder outcomes.
(Aim 1a). Examine the effects of the YC-PEM e-PRO on EI parent activation, parent engagement in EI services, service plan focus, and service use breadth and intensity. The investigators will test two hypotheses in this first sub-aim. As compared to children receiving usual EI care, intervention group subjects will: H1: report higher activation for shared decision-making and parent engagement when planning and monitoring the child's EI care within 12 months; H2: receive a greater breadth and intensity of participation-focused EI services within 12 months.
(Aim 1b). Examine the effects of the YC-PEM e-PRO on parent report of EI service quality. As compared to usual care subjects, the investigators expect that parents in the intervention group will report greater satisfaction with: H1: enabling and partnership; H2: general and specific information exchange for shared decision-making; H3: coordinated and comprehensive EI care; and H4: respectful and supportive EI care.
(Aim 1c). Examine the effects of the YC-PEM e-PRO on child functioning. As compared to usual EI care, intervention group children will: H1: demonstrate greater developmental gains, as measured by state-mandated and norm-referenced developmental tests done at EI entry and 12 months. H2: demonstrate greater gains in functional skills, as measured by state-mandated outcomes data at EI entry and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YC-PEM e-PRO | Experimental | Behavioral: Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)Participants are administered an electronic patient-reported outcome measure to obtain information about parent priorities, and they obtain a summary report of their responses to share with their early intervention team for discussion during the annual IFSP meeting. |
| Family Assessment | No intervention | –Participants are scheduled to complete a semi-structured family interview to obtain information about parent priorities, for use during the annual IFSP meeting |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Caregiver identifies as a parent or legal guardian of a child enrolled in early intervention
- Caregiver is at least 18 years old
- Caregiver reads, writes, and speaks English
- Caregiver has internet and telephone access
- Caregiver has a child who has received early intervention services for 3 or more months
Key exclusion criteria (5 listed)
- Caregiver is not the parent or legal guardian of a child enrolled in early intervention
- Caregiver is 0-17 years old
- Caregiver does not read, write, or speak English
- Caregiver does not have internet or telephone access
- Caregiver does not have a child who has received early intervention services for 3 or more months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)The Young Children's Participation in Environment Measure (YC-PEM) is an evidence-based option for comprehensive proxy assessment of a young child's current and desired participation in occupations across home, daycare, and community settings. The YC-PEM is an electronic patient-reported outcome (e-PRO) that provides individual caregivers a valid, reliable, and feasible way to communicate information about their child's current participation in home and community activities and areas of participation need. The gained information is then summarized and shared with the child's EI provide team to identify intervention priorities and goal attainment strategies in partnership with families. For quality improvement, EI programs can aggregate the YC-PEM e-PRO data to examine trends in participation as a function of EI service use. It is therefore a promising electronic health systems intervention to enhance the parent-practitioner relationship, and an NIH common data element for trials. | Behavioural | YC-PEM e-PRO |
Primary outcome
Measure of Processes of Care (MPOC-20)
Time frame: Baseline (pre-intervention)
Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.
Measure of Processes of Care (MPOC-20)
Time frame: 4 weeks
Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.
Measure of Processes of Care (MPOC-20)
Time frame: 6 months
Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.
Measure of Processes of Care (MPOC-20)
Time frame: 12 months
Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.
13 secondary outcomes
Parent Patient Activation Measure (P-PAM)
Time frame: Baseline (pre-intervention)
Parent Patient Activation Measure (P-PAM)
Time frame: 4 weeks
Parent Patient Activation Measure (P-PAM)
Time frame: 6 months
Parent Patient Activation Measure (P-PAM)
Time frame: 12 months
Parent Participation Engagement measure (PPEM)
Time frame: Baseline (pre-intervention)
Parent Participation Engagement measure (PPEM)
Time frame: 4 weeks
Parent Participation Engagement measure (PPEM)
Time frame: 6 months
Parent Participation Engagement measure (PPEM)
Time frame: 12 months
Early Intervention Service Use Quantity
Time frame: 1 month
Early Intervention Service Use Quantity
Time frame: 12 months
Early Intervention Service Plan Focus
Time frame: 4 weeks
Child Functioning
Time frame: Baseline (pre-intervention)
Child Functioning
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 42185022Bosak DL, Frame L, Bobitt J, Guillen C, Khetani MA. Refining implementation determinants and strategies to scale an electronic assessment option for coordinating family-centred care in early intervention. BMJ Paediatr Open. 2026 May 25;10(1):e003801. doi: 10.1136/bmjpo-2025-003801.
- Derived from this study: PubMed 42131290Kaelin VC, Rizk S, Chen YF, Dooling-Litfin J, Lerner Papautsky E, Leland NE, Murphy NJ, McManus BM, Lage CR, Villegas V, Kuznicki L, Pedrow A, Khetani MA; High Value Early Intervention Research Group. Electronic Patient-Reported Outcome Measure and Decision Support Tool Option for Early Intervention Service Quality: A Pilot Cluster-Randomized Pragmatic Trial. Adv Rehabil Sci Pract. 2026 May 7;15:27536351261445239. doi: 10.1177/27536351261445239. eCollection 2026 Jan-Dec.
- Derived from this study: PubMed 34983760Kaelin V, Villegas V, Chen YF, Murphy N, Papautsky E, Litfin J, Leland N, Maheshwari V, McManus B, Khetani M; High Value Early Intervention Research Group. Effectiveness and scalability of an electronic patient-reported outcome measure and decision support tool for family-centred and participation-focused early intervention: PROSPECT hybrid type 1 trial protocol. BMJ Open. 2022 Jan 4;12(1):e051582. doi: 10.1136/bmjopen-2021-051582.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary A Khetani principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO) in people with Child Development Disorder and Development Delay, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Processes of Care (MPOC-20) (time frame: Baseline (pre-intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04562038, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.