The Attachment, Regulation and Competency (ARC) Framework

Posttraumatic Stress Disorder Clinical Trial

Official title: Evaluation of the Attachment, Regulation and Competency (ARC) Framework for the Treatment of Complex Trauma in Children

Status Completed

Clinical Trial Summary

This study evaluates the effectiveness of the Attachment Regulation and Competency (ARC) treatment framework in comparison to treatment as usual for reducing symptoms of PTSD and Developmental Trauma Disorder among children ages 8 to 16 with a history of exposure to multiple traumatic events.

Clinical Trial Description

The primary goal of this project is to expand the knowledge base in the field of trauma informed interventions by addressing current gaps in the evidence base through: a) evaluation of the efficacy of an innovative intervention designed specifically for children who experience complex trauma and their caregivers, thereby evaluating strategies that are most effective, and b) examining how ARC promotes protective factors (self-regulation, caregiver wellness), thereby supporting the health and well-being of complexly traumatized children and their families. The overall purpose of the randomized controlled trial (RCT) is to examine the effectiveness of ARC on the range of developmental disruptions and clinical symptoms that represent complex trauma, as well as its utility for increasing the adaptive functioning of children and families. In particular it is necessary to determine: 1) if ARC will demonstrate effectiveness in reducing sequelae of complex trauma as determined by a scientifically rigorous randomized control trial study design; 2) the extent to which ARC positively impacts resiliency factors (self-regulation, executive functioning, caregiver wellness), thereby serving to moderate or mediate change in symptoms and functioning; and 3) the impact of ARC across multiple levels of the family ecology, including the child, the caregiver-child relationship (i.e., attachment) and caregiver stress and wellness.

The specific objectives of this research project are the following:

1. Recruit 182 children ages 8 to 16 with complex trauma and their adult caregivers, from clinical samples of children actively seeking treatment for mental health disorders and related difficulties from three community based outpatient clinics in the Commonwealth of Massachusetts.

2. Conduct comprehensive, clinical interviews with participants and their caregivers to assess sequelae of complex trauma, to determine underlying resiliency factors and to gather information regarding trauma exposure history, over four study time points (pre-, mid-, and post-treatment and 6-month follow up).

3. Deliver 24 sessions of once weekly ARC or TAU over a 6-month intervention period.

4. Evaluate the efficacy of ARC and TAU using a variety of sophisticated statistical methods, such as growth curve modeling, multivariate analyses, and hierarchical linear regression analyses.

5. Disseminate findings to: 1) the academic community via presentations at professional conferences and publications of data in peer reviewed journals; 2) the public, via the Trauma Center website, which received over 600,000 visitors in 2012, with 1,161,451 downloads of our manuscripts and resources for providers, consumers and state service agencies; and 3) the National Child Traumatic Stress Network (NCTSN) and Complex Trauma Treatment Network (CTTN) at annual network meetings, via their websites and through ongoing collaborations with partner network sites across the country. ;

Related Conditions & MeSH terms

• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

• NCT number: NCT05155228
• Study type: Interventional
• Source: Justice Resource Institute
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Completion date: March 31, 2021