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Task-Based Grounding Program

Primary Purpose

Aggressive, Defiant Disorder, Oppositional, Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Task-Based Grounding
Connected Care (Enhanced Treatment as usual)
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aggressive focused on measuring Oppositional Defiant Disorder, Behavioral Parent Training

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participating parent-child dyads must include a child between the ages of 9-14 years old and adult over the age of 18.
  • The child must have a Vanderbilt Oppositional Defiant Disorder score >3
  • The participating caregiver must be a legal guardian of participating child

Exclusion Criteria (child refers to the primary participant's child)

  • Child ever been hospitalized for a psychiatric problem
  • Child ever attempted suicide or stated that they had a plan to attempt suicide within the past year.
  • Child ever engaged in self-harm behaviors
  • Child has significant legal history such as adjudicated of a crime or been in diversion
  • Child has ever been diagnosed with: Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, Intellectual Disability or Developmental Delay, Speech or Hearing Delay, Autism Spectrum Disorder, Schizophrenia or another psychotic disorder, A substance abuse disorder (or had serious concerns about substance use).
  • Parent can communicate in spoken English
  • Parent is under the age of 18.

Sites / Locations

  • Dartmouth Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Task-Based Grounding

Connected Care (Enhanced treatment as usual)

Arm Description

Participating parents will be provided with three 50-minute Task Based Grounding sessions using a standardized manual over 6 weeks.

Participating parents will be provided with two sessions and one phone check-in call over 6 weeks. They will work with a "care navigator" to assess their child's needs, find them an appropriate referral for care, and help problem solve barriers to finding a therapist.

Outcomes

Primary Outcome Measures

Number of referred participants
Feasibility of recruitment will be measured by number of participants referred
Number of participants who screen positive
Feasibility of recruitment will be measured by number of participants who screen positive
Change from Baseline Session attendance at visit 3
Feasibility of the participant retention in the program will be measured by session attendance by participants
Number of participants enrolled
Feasibility of recruitment will be measured by number of participants enrolled
Number of participants who complete all assessment measures
Feasibility of assessment measures will be measured by number of participants who complete assessment measures
Fidelity of the training provided
as measured by having a trained listener code and score fidelity using a checklist developed specifically for the content of each session. Audio recording of intervention sessions will be used. There are 35 items on the checklist, each worth 1pt. Score will be in terms of percentage, with a minimum score of 0 and a maximum score 100%.
Intervention acceptability as measured by the Treatment Evaluation Inventory Short Form
as measured by Treatment Evaluation Inventory Short Form post intervention which measures intervention acceptance. The established cut off scores for determining if a treatment is acceptable is a score of 27. Min score possible is 0, max score possible is 32. Higher scores indicate greater acceptability.
Intervention Acceptability as measured by the Therapy Attitude Inventory
as measured by the Therapy Attitude Inventory post intervention which measures acceptability of behavioral parent trainings. Min score of 1 is possible, max score of 50 is possible. Higher scores indicate greater acceptability.
Intervention Acceptability as measured by the Participant Experiences Questionnaire
as measured by the Participant Experiences Questionnaire which measures acceptability of each skill module included in the program and is specific to program content. Min score of 0 possible, max score of 36 possible. Higher scores indicate greater acceptability.
Acceptability as measured by qualitative interview
as measured by 30 minute semi-structured qualitative interview with participants conducted by a research assistant trained and supervised by the study PI

Secondary Outcome Measures

Adherence to the intervention
as measured by daily logs that track both children's aggressive and defiant behaviors and parenting behaviors. A count of each time a parent used a skill from the program will be used to estimate adherence and assess whether they matched the appropriate skills to the reported misbehaviors.

Full Information

First Posted
November 14, 2020
Last Updated
November 5, 2021
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04648553
Brief Title
Task-Based Grounding Program
Official Title
A Pilot Randomized Control Trial of the Task-Based Grounding Program
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to improve the availability of brief interventions to help children with defiant, aggressive and disruptive behaviors by creating a brief scalable intervention for parents delivered via telehealth. As phase 1 study, we are conducting a 2-arm pilot feasibility RCT in order the intervention, measures, and procedures to be used in a larger efficacy trial. The first arm will include a 3-session behavioral therapy treatment we call Task-Based Grounding and the second arm will be an enhanced treatment as usual comparison group.
Detailed Description
The investigators have developed a 3-session psychosocial intervention for parents of children between 9-14 with disruptive behaviors. The intervention uses telehealth visits along with written and online resources to teach them parent management skills. To evaluate the acceptability of this intervention and the feasibility of our methods, the investigators will recruit 20 parent-child dyads to participate in this study. This is a mixed methods pilot feasibility RCT design. The investigators designed this study to test the acceptability of the intervention to parents and test the feasibility of our recruitment, retention, measurement, and delivery mechanisms for both the experimental and comparison conditions. The investigators will use a block randomization method to separate parent-child dyads into either treatment or comparison groups. The treatment condition involves 3 telehealth visits and a set of parenting resources. The enhanced treatment as usual condition will involve contact with a "care navigator" that will assess behavior problems in the child and help the parents find an appropriate referral to care in their community. Both groups will be followed for 10 weeks, provide outcome data, and participate in semi-structured qualitative interviews to accept acceptability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive, Defiant Disorder, Oppositional, Attention Deficit Hyperactivity Disorder
Keywords
Oppositional Defiant Disorder, Behavioral Parent Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Task-Based Grounding
Arm Type
Experimental
Arm Description
Participating parents will be provided with three 50-minute Task Based Grounding sessions using a standardized manual over 6 weeks.
Arm Title
Connected Care (Enhanced treatment as usual)
Arm Type
Sham Comparator
Arm Description
Participating parents will be provided with two sessions and one phone check-in call over 6 weeks. They will work with a "care navigator" to assess their child's needs, find them an appropriate referral for care, and help problem solve barriers to finding a therapist.
Intervention Type
Behavioral
Intervention Name(s)
Task-Based Grounding
Intervention Description
Three 50 minutes sessions with an interventionist that includes 6 non-punitive components of treatment common in Behavioral Parent Trainings: Education on behavior change, positive one-on-one time between parents and their children, differential attending to positive and negative behaviors, effective praise, giving effective instructions, and using a point and reward system to encourage prosocial behaviors. These components are distilled into 5 skill modules and paired with Task-Based Grounding, which involves a brief restriction of privileges and provides children with the opportunity to end the restriction by completing a prosocial task.
Intervention Type
Behavioral
Intervention Name(s)
Connected Care (Enhanced Treatment as usual)
Intervention Description
Two sessions with a facilitator. The facilitator does NOT provide any guidance to the parent on managing their child's behavior, but provides empathy and problem solving to help them find a resource that best fits their needs. It is particularly geared towards helping parents connect with Behavioral Parent Trainings to address the needs of children with oppositional, defiant, or aggressive behaviors.
Primary Outcome Measure Information:
Title
Number of referred participants
Description
Feasibility of recruitment will be measured by number of participants referred
Time Frame
Through study completion, approximately 5 months.
Title
Number of participants who screen positive
Description
Feasibility of recruitment will be measured by number of participants who screen positive
Time Frame
Through study completion, approximately 5 months.
Title
Change from Baseline Session attendance at visit 3
Description
Feasibility of the participant retention in the program will be measured by session attendance by participants
Time Frame
Session attendance will be taken at Session 1 (week 0) and Session 3 (week 6)
Title
Number of participants enrolled
Description
Feasibility of recruitment will be measured by number of participants enrolled
Time Frame
Through study completion, approximately 5 months.
Title
Number of participants who complete all assessment measures
Description
Feasibility of assessment measures will be measured by number of participants who complete assessment measures
Time Frame
Through study completion, approximately 5 months.
Title
Fidelity of the training provided
Description
as measured by having a trained listener code and score fidelity using a checklist developed specifically for the content of each session. Audio recording of intervention sessions will be used. There are 35 items on the checklist, each worth 1pt. Score will be in terms of percentage, with a minimum score of 0 and a maximum score 100%.
Time Frame
Through study completion, approximately 5 months.
Title
Intervention acceptability as measured by the Treatment Evaluation Inventory Short Form
Description
as measured by Treatment Evaluation Inventory Short Form post intervention which measures intervention acceptance. The established cut off scores for determining if a treatment is acceptable is a score of 27. Min score possible is 0, max score possible is 32. Higher scores indicate greater acceptability.
Time Frame
Follow-up/post intervention (up to 10 weeks)
Title
Intervention Acceptability as measured by the Therapy Attitude Inventory
Description
as measured by the Therapy Attitude Inventory post intervention which measures acceptability of behavioral parent trainings. Min score of 1 is possible, max score of 50 is possible. Higher scores indicate greater acceptability.
Time Frame
Follow-up/post intervention (up to 10 weeks)
Title
Intervention Acceptability as measured by the Participant Experiences Questionnaire
Description
as measured by the Participant Experiences Questionnaire which measures acceptability of each skill module included in the program and is specific to program content. Min score of 0 possible, max score of 36 possible. Higher scores indicate greater acceptability.
Time Frame
Follow-up/post intervention (up to 10 weeks)
Title
Acceptability as measured by qualitative interview
Description
as measured by 30 minute semi-structured qualitative interview with participants conducted by a research assistant trained and supervised by the study PI
Time Frame
Follow-up/post intervention (up to 10 weeks)
Secondary Outcome Measure Information:
Title
Adherence to the intervention
Description
as measured by daily logs that track both children's aggressive and defiant behaviors and parenting behaviors. A count of each time a parent used a skill from the program will be used to estimate adherence and assess whether they matched the appropriate skills to the reported misbehaviors.
Time Frame
Available for completion every day for 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participating parent-child dyads must include a child between the ages of 9-14 years old and adult over the age of 18. The child must have a Vanderbilt Oppositional Defiant Disorder score >3 The participating caregiver must be a legal guardian of participating child Exclusion Criteria (child refers to the primary participant's child) Child ever been hospitalized for a psychiatric problem Child ever attempted suicide or stated that they had a plan to attempt suicide within the past year. Child ever engaged in self-harm behaviors Child has significant legal history such as adjudicated of a crime or been in diversion Child has ever been diagnosed with: Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, Intellectual Disability or Developmental Delay, Speech or Hearing Delay, Autism Spectrum Disorder, Schizophrenia or another psychotic disorder, A substance abuse disorder (or had serious concerns about substance use). Parent can communicate in spoken English Parent is under the age of 18.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James T Craig, Ph.D.
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Task-Based Grounding Program

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