NCT01344382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

5.3 years

First QC Date

April 27, 2011

Last Update Submit

March 27, 2023

Conditions

Keywords

AdolescentParentSubstance AbuseParent TrainingCommunity Reinforcement and Family TrainingCRAFTCommunity Reinforcement ApproachAddictionFamily Intervention

Outcome Measures

Primary Outcomes (1)

  • Treatment Entry

    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.

    Each session and 3-, 6-, and 12-months post-baseline

Secondary Outcomes (6)

  • Adolescent Substance Use

    Baseline and 3-, 6-, and 12- months post-baseline

  • Adolescent Behavior Problems

    Baseline and 3-, 6-, and 12-months post baseline

  • Improvement in Parenting Skills

    Baseline and 3-, 6-, and 12-months post-baseline

  • Parent Social Functioning

    Baseline and 3-, 6-, and 12-months post-baselin

  • Parent Mood

    Baseline and 3-, 6-, and 12-months post-baseline

  • +1 more secondary outcomes

Study Arms (2)

CRAFT

EXPERIMENTAL

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

Al-Anon Facilitation

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: CRAFT
CRAFT

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.

Also known as: ANF
Al-Anon Facilitation

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parent Criteria
  • parent is over 21 yrs old
  • parent expresses concern about the drug abuse of their adolescent or young adult
  • 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
  • parent has an adolescent or young adult with primary drug abuse of alcohol or a psychoactive drug other than tobacco or caffeine
  • the adolescent/young adult is between 12-25 yrs old at time of consent
  • 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
  • \. child's parent meets all eligibility criteria and consents to participate

You may not qualify if:

  • Parent Criteria
  • parent does not agree to participate
  • 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
  • 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)
  • parent has a drug abuse problem themselves as determined through PSUD (DSM-IV-TR criteria)
  • parent has a history of drug abuse or dependence and has not been in recovery for more than 2 yrs
  • parent is in a close relationship with another participant such that their participation is unlikely to be independent
  • parent is not able to comprehend the content in the questionnaires even after it is explained several times
  • 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)
  • parent is currently receiving treatment that addresses the adolescent's substance use (e.g., family therapy)
  • adolescent has a recent history of severe violence toward the parent(s) (e.g., involving weapons, serious injury, or hospitalization).
  • Adolescent/Young Adult Criteria
  • adolescent/young adult does not agree to participate
  • 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
  • adolescent/young adult is not able to comprehend the content in the questionnaires even after it is explained several times
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Training Program

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersBehavior, Addictive

Interventions

Atrial Natriuretic Factor

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Kimberly C Kirby, PhD

    Treatment Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2011

First Posted

April 29, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations