The Attachment, Regulation and Competency (ARC) Framework

NCT ID: NCT05155228

Last Updated: 2021-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2021-03-31

Brief 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.

Detailed 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.

Conditions

Posttraumatic Stress Disorder; Developmental Trauma Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Attachment Regulation and Competency

Weekly individual psychotherapy for 24 weeks using the Attachment Regulation and Competency intervention.

Group Type: EXPERIMENTAL

Attachment Regulation and Competency

Intervention Type: BEHAVIORAL

Trauma informed psychotherapy intervention for children with a history of exposure to trauma and their caregivers.

Treatment as usual

Weekly individual psychotherapy for 24 weeks.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

Supportive psychotherapy

Interventions

Attachment Regulation and Competency

Trauma informed psychotherapy intervention for children with a history of exposure to trauma and their caregivers.

Intervention Type: BEHAVIORAL

Treatment as usual

Supportive psychotherapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. DTD diagnosis as measured by the DTD interview (using standard scoring criteria) or partial PTSD diagnosis as measured by the CAPS.

2. A history of at least two forms of trauma, at least one of which must be interpersonal in nature (sexual, physical or psychological maltreatment, neglect, abandonment or impaired caregiving) as indicated on the Trauma History Profile (THP).

Exclusion Criteria

1. Serious illness that is not stabilized.

2. GAF < 40.

3. Past diagnosis of autism spectrum disorder, mental retardation, or schizophrenia.

4. Current psychotic disorder or established organic impairment (e.g., TBI).

5. Active suicidal risk, self-mutilation or homicidal behavior toward others within the past 3 months, as judged by the PI.

6. Previous ARC treatment.

7. Any other condition that might interfere with the person's capacity to give informed consent, or to adhere to the study protocol.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Justice Resource Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hilary B Hodgdon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Trauma Center at JRI

Locations

Trauma Center at JRI

Brookline, Massachusetts, United States

Countries

United States

Other Identifiers

JRI 2016-03

Identifier Type: -

Identifier Source: org_study_id