Clinical trial NCT01344382: Family Training Program for Parents of Substance Using Adolescents
Official title: CRAFT: Helping Parents Initiate and Support Their Adolescent's Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Substance-Related Disorders
Drug Addiction
Substance Abuse
Keywords: Adolescent
Parent
Substance Abuse
Parent Training
Community Reinforcement and Family Training
CRAFT
Community Reinforcement Approach
Addiction
Family Intervention
Lead sponsor: Public Health Management Corporation
Sponsor class: OTHER
Collaborators: name: Robert J. Meyers PhD & Associates
name: National Institute on Drug Abuse (NIDA)
First posted: 2011-04-29
Enrollment: 126
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project will modify Community Reinforcement and Family Training (CRAFT; n=15) and Alanon/Naranon Facilitation (ANF; n=15) for use with parents who are concerned about an out-of-treatment adolescent. ANF was selected as a comparison because Alanon and Naranon are the most commonly available method for helping family members. The investigators will compare CRAFT for parents (CRAFT-P) (n=77) and ANF (n=77) to determine if there is a significant difference in adolescent treatment entry. Parents will attend a maximum of 18 sessions with a family specialist and also complete questionnaires periodically over a 12-month period. Parents' adolescents will have the opportunity to participate in the study by completing questionnaires at the same time points as their parent. Our primary hypothesis asks whether participants who are enrolled in the CRAFT-P condition will report more adolescent treatment entry than the ANF condition. Our secondary hypotheses examine: 1) reductions in adolescent substance use and behavior problems in the CRAFT-P group compared to the ANF condition, 2) improvements in parenting skills in the CRAFT-P group compared to the ANF condition and 3) significant pre to post treatment effects for improvements in social functioning, mood, and in parent-adolescent relationship satisfaction.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Parent Criteria

1. parent is over 21 yrs old
2. parent expresses concern about the drug abuse of their adolescent or young adult
3. parent has the ability to have face-to-face contact with the child on at least 15 out of 30 days with no planned decrease in the amount of contact in the next 12 mo
4. parent has an adolescent or young adult with primary drug abuse of alcohol or a psychoactive drug other than tobacco or caffeine
5. the adolescent/young adult is between 12-25 yrs old at time of consent
6. the child is not receiving treatment addressing the drug abuse/dependence and is not willing for treatment at the time of parental study consent

Adolescent/Young Adult Criteria

1. child's parent meets all eligibility criteria and consents to participate

Exclusion Criteria:

Parent Criteria

1. parent does not agree to participate
2. parent who is providing consent does not demonstrate understanding of participation by reading the consent form and passing a consent quiz testing comprehension of basic elements of informed consent and requirements of the protocol
3. parent is not willing and able to provide valid locator information, to allow training sessions to be recorded, and/or to complete follow-up assessments (determined via consent quiz)
4. parent has a drug abuse problem themselves as determined through PSUD (DSM-IV-TR criteria)
5. parent has a history of drug abuse or dependence and has not been in recovery for more than 2 yrs
6. parent is in a close relationship with another participant such that their participation is unlikely to be independent
7. parent is not able to comprehend the content in the questionnaires even after it is explained several times
8. parent or adolescent/young adult has been diagnosed as having or behaves in a manner consistent with having significant cognitive impairment (e.g., unremitting psychosis, dementia, or other severe psychiatric disorder)
9. parent is currently receiving treatment that addresses the adolescent's substance use (e.g., family therapy)
10. adolescent has a recent history of severe violence toward the parent(s) (e.g., involving weapons, serious injury, or hospitalization).

Adolescent/Young Adult Criteria

1. adolescent/young adult does not agree to participate
2. adolescent/young adult who is providing consent or assent does not demonstrate understanding of participation by reading the consent/assent form and passing a quiz testing comprehension of basic elements of informed consent and requirements of the protocol
3. adolescent/young adult is not able to comprehend the content in the questionnaires even after it is explained several times
4. adolescent/young adult has been diagnosed as having or behaves in a manner consistent with having significant cognitive impairment (e.g., unremitting psychosis, dementia, or other severe psychiatric disorder)

Primary outcomes:
measure: Treatment Entry
timeFrame: Each session and 3-, 6-, and 12-months post-baseline
Secondary outcomes:
measure: Adolescent Substance Use
timeFrame: Baseline and 3-, 6-, and 12- months post-baseline
measure: Adolescent Behavior Problems
timeFrame: Baseline and 3-, 6-, and 12-months post baseline
measure: Improvement in Parenting Skills
timeFrame: Baseline and 3-, 6-, and 12-months post-baseline
measure: Parent Social Functioning
timeFrame: Baseline and 3-, 6-, and 12-months post-baselin
measure: Parent Mood
timeFrame: Baseline and 3-, 6-, and 12-months post-baseline
measure: Relationship Satisfaction
timeFrame: Baseline and 3-, 6-, 12-months post-baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Family Training Program
state: Pennsylvania
Study officials:
affiliation: Treatment Research Institute
name: Kimberly C Kirby, PhD
role: PRINCIPAL_INVESTIGATOR
References: