- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01744951
Adoption-specific Treatment Prevention Pilot Trial (ADAPT)
Evaluate the Adoption-specific Prevention Treatment Program (ADAPT)
This study seeks to pilot a manualized adoption-specific intervention aimed at providing a preventive intervention for families adopting children ages 5-14 years where family reunification has been terminated and the family is moving toward adoption or who have adopted children from foster care in the last three years. This work will fill a major gap in services to children and families and is developed to improve mental health and family functioning of children adopted from foster care, as well as decrease adoption disruptions. President Clinton's 1997 adoption initiative, The Adoption and Safe Families ACT (ASFA), along with subsequent Congressional initiatives, have provided incentives to States and subsidies for adopting older children with a resultant increase in rates of adoption from foster care from 26,000 in 1995 to 53,000 (stabilized annual rate) beginning in 2002. The mean age at adoption from foster care is now 6 years old. These older children have histories of physical and sexual abuse, neglect, and multiple placements, all factors that predict behavior problems over time. To address this gap in our knowledge of providing care for this vulnerable group, we have developed a manualized adoption-specific intervention for families adopting children from foster care. Because adoptive children generally enter homes with stable, well-functioning parents, interventions may be particularly effective in helping the children adjust and their parents learn to understand and manage children with difficult past histories.
The aim of this current pilot trial is to test this intervention designed to improve the outcomes for children adopted from foster care through a randomized trial. Our hypothesis is that this manualized adoption-specific intervention will be more effective than care as usual in improving child mental health and family functioning outcomes; specifically, families and children who have been randomized to the manualized adoption-specific intervention will show better outcomes on the post-treatment measures and the 3 month follow-up than on the pre-treatment measures than the care as usual families and children.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90007
- Children's Bureau of Southern California
-
Los Angeles, California, United States, 90095
- UCLA TIES for Familes
-
Torrance, California, United States, 90502
- UCLA TIES for Families South Bay
-
-
Maryland
-
Burtonsville, Maryland, United States, 20866
- Center for Adoption Support and Education
-
-
North Carolina
-
Greensboro, North Carolina, United States, 27405
- Children's Home Society North Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children being adopted from foster care, ages 5-14
- Children (within above age range) who have been adopted in the last three years
- Family reunification services have been terminated
Exclusion Criteria:
- Children with the following Diagnostic and Statistical Manual psychiatric disorders will be excluded from study participation: Pervasive Developmental Disorders (e.g. Asperger's, autism, mental retardation, or psychotic disorder as known to the parents
- Children will be excluded if the child has a major neurological disorder or a major medical illness that would interfere with participation in the study
- Children who pose a significant risk for dangerousness to self or others that makes participating inadvisable
- Children and/or parents who are non-English speaking and unable to complete treatment without a translator will not be included
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ADAPT
ADAPT is a manualized intervention with eight treatment modules designed as an early intervention for children, ages 5-14, who are being adopted from foster care and their adoptive parent/s.
|
ADAPT consists of the following modules/sessions: Module 1: Trust, positive coping strategies, and behavior management; Module 2: Developmental understanding of adoption experience; Module 3: Substance abuse prevention; Module 4: Loss and grief issues about birth family and foster care; Module 5: Attachment/joining with adoptive family; Module 6: Search for identity/self -esteem; Module 7: Adoption and the outside world; Module 8: Trauma Treatment (if appropriate) |
No Intervention: Care as usual
Children, ages 5-14, and their adoptive parent/s will receive care as usual in the treatment setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent Weekly Report
Time Frame: Participants will be followed for the duration of the therapeutic intervention, an expected average of 24 weeks.
|
The Parent Weekly Report consists of two measures: Brief Problem Checklist (Chorpita et al., 2010 and Parent Daily Report (Chamberlain & Reid, 1987).
|
Participants will be followed for the duration of the therapeutic intervention, an expected average of 24 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of child participants whose internalizing and externalizing behaviors improve
Time Frame: 0 weeks, 24 weeks, 36 weeks
|
Child participants' internalizing and externalizing behaviors will be measured at the three distinct times by using both child and parent measures: 1. Emotional Distress and Functioning:Children's Depression Inventory, Screen for Childhood Anxiety Related Emotional Disorders (SCARED),Child PTSD Symptom Scale (CPSS),Achenbach Child Behavior Checklists and Teacher Report Forms (CBCL),Children's Global Assessment Scale (CGAS) 2.Targeted Resilience Factors: Emotion Regulation Checklist (ER Checklist),Kidcope 3.Understanding of Adoption: Adoption Dynamics Questionnaire (ADQ),Children's Beliefs about Adoption Scale (CBAAS) 4.Family Environment and Parental Distress,Family Environment Scale (FES),Brief Symptom Inventory (BSI) 5.Attachment and Parenting: Inventory of Parent and Peer Attachment (IPPA) 6.Trauma Exposure: Modified Life Events Scale (LES) 7.Process Variables: Therapeutic Alliance Scale for Children (TASC),Working Alliance Inventory (WAI),Consumer Satisfaction Questionnaire
|
0 weeks, 24 weeks, 36 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jeanne Miranda, Ph.D., University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ADAPT-02
- UCLA IRB/IRB# 12-001024 (Other Grant/Funding Number: Annie E Casey Foundation/212.0023)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prevent Disorders in Children Adopted From Foster Care
-
Poul BakTRYG FoundationUnknownChildren and Adolescents in Foster Care and Residential CareDenmark
-
WestatOffice of Planning, Research & Evaluation; Children's Bureau ACYF; University...CompletedSerious Emotional Disturbance | In Foster Care
-
Children's Hospital Medical Center, CincinnatiCompletedAnxiety | Behavior Disorders | Psychological Disorder | Development; Delayed, Mental | Situational Anxiety | Fear of Other Medical Care | Behavior, Coping | Behavior Disorders in ChildrenUnited States
-
Tampere University HospitalTurku University Hospital; Kuopio University Hospital; Seinajoki Central Hospital and other collaboratorsEnrolling by invitationCeliac Disease | Diet, Gluten-Free | Celiac Disease in Children | Follow-up | Transition of CareFinland
-
University of FloridaNot yet recruitingConcussion, Mild | Sports Injuries in Children | Cognitive Impairments | Post Concussion Symptoms | Cognitive Impairments, Mild | Learning Disturbance | Multidisciplinary Care Team | Team Nursing
Clinical Trials on ADAPT
-
Boston UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedPrediabetesUnited States
-
University of MinnesotaArizona State UniversityCompleted
-
University of MinnesotaCompletedParentingUnited States
-
University of California, IrvineNational Institute of Mental Health (NIMH); Northwestern University; Mental Health...CompletedDepression, AnxietyUnited States
-
Kaiser PermanenteWithdrawnDepression | AnxietyUnited States
-
East Carolina UniversityAkron Children's Hospital; Palliative Care Research Cooperative GroupCompleted
-
UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI); Duke University; RTI InternationalNot yet recruitingObesity | Overweight | Overweight and ObesityUnited States
-
Michigan State UniversityNational Center for Complementary and Integrative Health (NCCIH); Spectrum...CompletedAnxiety | Functional Abdominal Pain SyndromeUnited States
-
University of MinnesotaCompleted
-
Christian CandrianRecruiting