Task-Based Grounding Program

Dartmouth Health

Status and phase: Completed; Phase 1

Conditions: Attention Deficit Hyperactivity Disorder; Aggressive; Defiant Disorder, Oppositional

Treatments: Behavioral: Connected Care (Enhanced Treatment as usual); Behavioral: Task-Based Grounding

Study type: Interventional

Funder types: Other

Identifiers

NCT04648553

D21019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Task-Based Grounding

Experimental group

Description:

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

Treatment:

Behavioral: Task-Based Grounding

Connected Care (Enhanced treatment as usual)

Sham Comparator group

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.

Treatment:

Behavioral: Connected Care (Enhanced Treatment as usual)