Task-Based Grounding Program

Study Overview
=================
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.

Official Title
-----------------
A Pilot Randomized Control Trial of the Task-Based Grounding Program

Conditions
-----------------
Aggressive, Defiant Disorder, Oppositional, Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Behavioral: Task-Based Grounding
* Behavioral: Connected Care (Enhanced Treatment as usual)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Task-Based Grounding<br>Participating parents will be provided with three 50-minute Task Based Grounding sessions using a standardized manual over 6 weeks. | Behavioral: Task-Based Grounding<br>* 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.<br>|
| Sham Comparator: Connected Care (Enhanced treatment as usual)<br>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. | Behavioral: Connected Care (Enhanced Treatment as usual)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of referred participants | Feasibility of recruitment will be measured by number of participants referred | Through study completion, approximately 5 months. | 
| Number of participants who screen positive | Feasibility of recruitment will be measured by number of participants who screen positive | Through study completion, approximately 5 months. | 
| Change from Baseline Session attendance at visit 3 | Feasibility of the participant retention in the program will be measured by session attendance by participants | Session attendance will be taken at Session 1 (week 0) and Session 3 (week 6) | 
| Number of participants enrolled | Feasibility of recruitment will be measured by number of participants enrolled | Through study completion, approximately 5 months. | 
| Number of participants who complete all assessment measures | Feasibility of assessment measures will be measured by number of participants who complete assessment measures | Through study completion, approximately 5 months. | 
| 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%. | Through study completion, approximately 5 months. | 
| 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. | Follow-up/post intervention (up to 10 weeks) | 
| 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. | Follow-up/post intervention (up to 10 weeks) | 
| 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. | Follow-up/post intervention (up to 10 weeks) | 
| 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 | Follow-up/post intervention (up to 10 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Available for completion every day for 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oppositional Defiant Disorder, Behavioral Parent Training