Family Training Program for Parents of Substance Using Adolescents (FTP)
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|ClinicalTrials.gov Identifier: NCT01344382|
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : September 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Substance-Related Disorders Drug Addiction Substance Abuse||Behavioral: Community Reinforcement and Family Training Behavioral: Al-Anon Facilitation||Phase 1 Phase 2|
Data suggest that as many as 60% of parents who are aware and concerned about their adolescent's substance use are unable to get them into treatment without assistance (Szapocznik et al., 1988) and very little research has examined methods to help them. Community Reinforcement and Family Training (CRAFT) was developed to help family members foster treatment entry of treatment-resistant adults, but it has not been tested in a controlled trial with parents of substance-abusing adolescents. This project will modify CRAFT (CRAFT-P) and Alanon/Naranon Facilitation (ANF) for use with parents who are concerned about an out-of-treatment adolescent.
The purpose of this study is to examine the efficacy of the CRAFT-P program in helping parents to: 1) facilitate treatment entry of their child, 2) achieve the outcomes they desire for their adolescents, 3) improve parenting skills in general and in acquisition of CRAFT knowledge in particular, and 4) improve their own mood and functioning. In addition the investigators will examine parents whose child entered treatment to estimate effect sizes of the new CRAFT methods for facilitating parent-supported treatment retention and aftercare engagement in community-based settings. Finally, if the CRAFT program appears efficacious, additional translational work will be initiated in collaboration with the Partnership at Drugfree.org (formerly the Partnership for a Drug-Free America) to provide parents with direct access to components of the CRAFT program.
A Stage II two-group randomized controlled clinical trial will compare CRAFT-P vs ANF. The investigators will collect data from approximately 308 participants (154 parents and 154 adolescents) and each participant will be involved in the study for a maximum of 12 months. The total enrollment number is not exact because it is possible that some adolescents will decline to participate.
Parents will be screened to determine their eligibility. If eligible and interested in participating in the study, the parent will then provide informed consent and give permission for their adolescent to participate in the study. Parents will be randomized to one of the two interventions, CRAFT-P or ANF. Each session will be audio-recorded and stored so that the investigators can complete on-going monitoring to minimize condition bleeding and protect against trainer drift. In addition to completing screening and baseline assessments, parents and adolescents will complete full assessment batteries at 3-, 6-, & 12-months post-baseline. The adolescents' research participation involves completing the assessment battery only and these data will be compared to parent reports to examine consistency.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||CRAFT: Helping Parents Initiate and Support Their Adolescent's Treatment|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
All parents will be scheduled for 12 individual Community Reinforcement and Family Training for parents (CRAFT-P) training sessions within 120 days and allowed to use up to 6 additional emergency sessions at any time up to the 12-mo follow-up. The first session will last 90 min; the remaining sessions will be 50 - 60 min in duration. Emergency sessions typically last 30 - 60 min and are used to assist the parent with crisis situations during the treatment period (e.g., adolescent violence, arrest) or for booster sessions after.
Behavioral: Community Reinforcement and Family Training
The philosophy of Community Reinforcement and Family Training (CRAFT) is that drug abuse is caused by multiple biological and environmental factors, many of which are beyond the parents' control. However, because parents have an important relationship with their child, they may able to influence his or her behavior. CRAFT for parents (CRAFT-P) will teach the parent new ways to interact with their child. Sessions will be designed to build the parents' motivation to comply with the training, conduct a functional analysis of their child's drug use pattern, train methods of behavior management and communication skills, enrich the parent's life and to suggest and motivate treatment entry.
Other Name: CRAFT
Active Comparator: Al-Anon Facilitation
All parents will be scheduled for 12 individual Alanon/Naranon Facilitation Training (ANF) sessions within 120 days and allowed to use up to 6 additional emergency sessions at any time up to the 12-mo follow-up. The first session will last 90 min; the remaining sessions will be 50 - 60 min in duration. Emergency sessions typically last 30 - 60 min and are used to assist the parent with crisis situations during the treatment period (e.g., adolescent violence, arrest) or for booster sessions after.
Behavioral: Al-Anon Facilitation
Al-Anon Facilitation (ANF) parallels the Twelve Step Facilitation intervention developed by Nowinski et al. (1992) for Project MATCH. The content focuses on introducing parents to Alanon or Naranon's purpose and philosophy, educating about 12-step concepts, the fellowship community, denial and enabling, acceptance, caring detachment, and surrendering to a higher power. The trainer's role is to help the parent to gain insight into the ways they interact with their child and to educate and encourage the parent to become actively involved in a 12-step community and to take advantage of its many offerings.
Other Name: ANF
- Treatment Entry [ Time Frame: Each session and 3-, 6-, and 12-months post-baseline ]The primary outcome measure is treatment entry of the adolescent substance user. This data will be collected via the Supplemental Services Form which is completed by parent participants prior to each session with their specialist and during follow-up assessments. The form is also completed by the adolescent at each follow-up up assessment. Parents or adolescents may also inform study staff of treatment entry at any time during the study.
- Adolescent Substance Use [ Time Frame: Baseline and 3-, 6-, and 12- months post-baseline ]We will assess adolescent substance use in two ways. Parents will complete the Timeline Follow Back about their adolescent's drug use and the adolescents will also complete the Timeline Follow Back if they're a study participant. In addition, adolescent study participants will give a urine sample to be tested for 8 drugs during each follow-up assessment.
- Adolescent Behavior Problems [ Time Frame: Baseline and 3-, 6-, and 12-months post baseline ]Adolescent behavior problems will be measured with the Child Behavior Checklist or Adult Behavior Checklist(completed by parent participants) and the Youth Self Report or Adult Self Report(completed by adolescent/Young Adult participants).
- Improvement in Parenting Skills [ Time Frame: Baseline and 3-, 6-, and 12-months post-baseline ]The Adolescent Parenting Questionnaire will be completed by parent participants. In addition, parents will complete the Family Training Survey and the Parent Role Play Assessment to assess CRAFT knowledge.
- Parent Social Functioning [ Time Frame: Baseline and 3-, 6-, and 12-months post-baselin ]Social functioning will be measured using the Stress Index for Parents of Adolescents
- Parent Mood [ Time Frame: Baseline and 3-, 6-, and 12-months post-baseline ]Parent mood will be measured with the Profile of Mood States Questionnaire Brief Form.
- Relationship Satisfaction [ Time Frame: Baseline and 3-, 6-, 12-months post-baseline ]Parent participants will complete the Parent Happiness with Youth Scale to measure relationship satisfaction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344382
|United States, Pennsylvania|
|Family Training Program|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||Kimberly C Kirby, PhD||Treatment Research Institute|