A Phase 1 interventional study of Task-Based Grounding and Connected Care (Enhanced Treatment as usual) in Aggressive, Defiant Disorder, Oppositional and Attention Deficit Hyperactivity Disorder, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2021-11-08.
Sponsored by Dartmouth-Hitchcock Medical Center · Phase 1, Interventional, and Treatment
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.
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.
248 studies on the registry are indexed under Aggression; 41 are open to participants now.
This study's enrollment of 28 is below the median of 80 across 221 interventional studies indexed under Aggression.
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Inclusion Criteria:
Exclusion Criteria (child refers to the primary participant's child)
Participating parents will be provided with three 50-minute Task Based Grounding sessions using a standardized manual over 6 weeks.
Behavioral: Task-Based Grounding
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)
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.
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.
Number of referred participants
Feasibility of recruitment will be measured by number of participants referred
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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%.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Follow-up/post intervention (up to 10 weeks)
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.
Time frame: Available for completion every day for 10 weeks
Plan to share: No
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