Task-Based Grounding Program

NCT04648553 | Completed Phase 1

• 1 other identifier: D21019
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Aggressive; Defiant Disorder, Oppositional; Attention Deficit Hyperactivity Disorder

Keywords

Oppositional Defiant Disorder; Behavioral Parent Training

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (1)

• Adherence to the intervention

  Available for completion every day for 10 weeks

Study Arms (2)

Task-Based Grounding

EXPERIMENTAL

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

Behavioral: Task-Based Grounding

Connected Care (Enhanced treatment as usual)

SHAM COMPARATOR

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)

Interventions

Task-Based Grounding BEHAVIORAL

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.

Task-Based Grounding

Connected Care (Enhanced Treatment as usual) BEHAVIORAL

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.

Connected Care (Enhanced treatment as usual)

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Aggression; Oppositional Defiant Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• James T Craig, Ph.D.

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: December 1, 2020
• Study Start: December 3, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)