Clinical trial NCT04648553: Task-Based Grounding Program
Official title: A Pilot Randomized Control Trial of the Task-Based Grounding Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aggressive
Defiant Disorder, Oppositional
Attention Deficit Hyperactivity Disorder
Keywords: Oppositional Defiant Disorder
Behavioral Parent Training
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 28
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of referred participants
timeFrame: Through study completion, approximately 5 months.
measure: Number of participants who screen positive
timeFrame: Through study completion, approximately 5 months.
measure: Change from Baseline Session attendance at visit 3
timeFrame: Session attendance will be taken at Session 1 (week 0) and Session 3 (week 6)
measure: Number of participants enrolled
timeFrame: Through study completion, approximately 5 months.
measure: Number of participants who complete all assessment measures
timeFrame: Through study completion, approximately 5 months.
measure: Fidelity of the training provided
timeFrame: Through study completion, approximately 5 months.
measure: Intervention acceptability as measured by the Treatment Evaluation Inventory Short Form
timeFrame: Follow-up/post intervention (up to 10 weeks)
measure: Intervention Acceptability as measured by the Therapy Attitude Inventory
timeFrame: Follow-up/post intervention (up to 10 weeks)
measure: Intervention Acceptability as measured by the Participant Experiences Questionnaire
timeFrame: Follow-up/post intervention (up to 10 weeks)
measure: Acceptability as measured by qualitative interview
timeFrame: Follow-up/post intervention (up to 10 weeks)
Secondary outcomes:
measure: Adherence to the intervention
timeFrame: Available for completion every day for 10 weeks
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: James T Craig, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: