- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536217
Developmental Pilot of Support Groups for Caregivers of Children With DLD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19713
- University of Delaware
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Caregiver of an elementary aged (5-12 year old) child with a lab-confirmed diagnosis of DLD
Exclusion Criteria:
- Not able to participate via teletherapy in a support group delivered in English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Developmental Pilot for Support Groups
Participants will join a teletherapy delivered support group for caregivers of children with DLD.
They will attend 8-10 weekly support group meetings and provide feedback on the meeting content and format so that we can revise the materials and evaluate early efficacy prior to a larger in person pilot.
|
A manualized support group for families who care for a child with developmental language disorder (DLD)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative interviews with participants
Time Frame: up to 2 weeks after intervention
|
Focus group and/or one-on-one interviews with support group participants
|
up to 2 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survey on Knowledge Seeking Behaviors
Time Frame: up to 4 weeks before and 2 weeks after intervention
|
We will use a survey developed by Darefsky (2022, adapted from (Al-Daihani & Al-Ateeqi, 2015). The survey consists of 9 total questions, of which there are two yes/no items, two multiple choice items, and four Likert scale items. This measure is not scored in a way that results in minimum or maximum scores, or outcomes. This measure is used to collect descriptive information about types and sources of information that caregivers desire in relation to their child's diagnosis. |
up to 4 weeks before and 2 weeks after intervention
|
|
Child Adjustment and Parent Efficacy Scale
Time Frame: up to 4 weeks before and 2 weeks after intervention
|
The Child Adjustment and Parent Efficacy Scale (CAPES; Morawska & Sanders, 2010) includes 50 Likert scale items This yields two measurements: one for Child Emotional and Behavioral Problems and one for Parent Efficacy. Child Emotional and Behavioral Problems: Minimum score = 0; Maximum score = 81. Higher scores indicate greater levels of child problems. Parent Efficacy: Minimum score = 19; Maximum score = 190 Higher scores indicate greater levels of parent self-efficacy. |
up to 4 weeks before and 2 weeks after intervention
|
|
Parenting Stress Index, Fourth Edition Short Form
Time Frame: up to 4 weeks before and 2 weeks after intervention
|
The Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF; Abidin, 2012)includes 36 items.
Minimum score = 36; Maximum score = 180.
Higher scores indicate higher parent stress levels.
|
up to 4 weeks before and 2 weeks after intervention
|
|
Family Support Scale
Time Frame: up to 4 weeks before and 2 weeks after intervention
|
The Family Support Scale (FSS; Dunst, et al., 1984)includes 18 Likert scale items. Minimum score = 0 Maximum score = 95 Higher scores indicate more family support. |
up to 4 weeks before and 2 weeks after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weekly Support Group Attendance
Time Frame: throughout intervention, up to 8 weeks.
|
We track individual attendance at each support group meeting.
Minimum score is 1 and maximum score is 8.
The maximum score indicates full participation in all meetings.
|
throughout intervention, up to 8 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amanda Van Horne, PhD, University of Delaware
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21DC022878 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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