In this clinical trial, convenience sampling was applied to select the participants from all drug abusers who visited the Mehr center of addiction treatment and rehabilitation facility (Mashhad, Iran), during spring and winter 2012. Sampling lasted for six months; forty people were selected in winter and 20 people in spring. There was no gap in time and sampling depended on number of referred addicts in clinic. Furthermore, the intervention program lasted for two months. Individuals were included only if they had a non-addict, literate family member who agreed to participate in the study and problem-solving sessions, were Iranian citizens, had lived in Mashhad for at least five years, aged between 16 and 40 years old, and could read and write. Addiction was confirmed by the facility’s physician based on patient records. Other inclusion criteria were heroin or opium abuse, history of addiction less than ten years, not having experienced more than two relapses, absence of drug dependence, and not having attended a formal training course on addiction. Finally, the participants (either the patients or their family members) could not be health personnel.
During the course of the study, subjects who developed psychological disorders, chronic and progressive diseases such as cancer and diabetes, and infectious diseases like AIDS and hepatitis, according to the facility’s specialists, were excluded. The intervention group members who failed to participate in training classes or more than one problem-solving education session were also excluded. Besides, unwillingness of the participants and/or their family members to continue the treatment program led to their exclusion.
Based on similar clinical trials, the sample size was calculated using the difference in means formula and considering the maximum number of subjects and self efficacy as the dependent variable.

With Confidence Interval (CI) and test power equal to 95% (α = 5%) and 80% (β = 20%), respectively, the sample size was determined as 30. The selected subjects were then allocated to either intervention or control group using coin flips.
At the beginning of the study, the participants were asked to provide written informed consent and introduced an eligible family member with whom they felt more comfortable. A questionnaire containing demographic characteristics, the Coopersmith Self Esteem Inventory (CSEI), and Quit Addiction Self Efficacy Questionnaire (QASEQ) were filled out for all subjects at baseline. The latter is a 16-item questionnaire designed by Bramson to assess self efficacy in drug dependent patients. It measures problem solving, decision-making, self-expression, and relationship skills using questions scored based on a seven-point Likert scale (with scores one to seven for definitely no, probably no, perhaps no, no idea, perhaps yes, probably yes, definitely yes, respectively) resulting in a total score of 16 to 112. The validity of the QASEQ was confirmed by Martin (1995) and Bramson (1999) Face and content validity of the Farsi version of the QASEQ was also evaluated by Habibi et al. who reported the correlation between QASEQ and the General Self Efficacy Questionnaire (a validated questionnaire in Iran) as r = 0.6 (P < 0.001)(
25). The reliability of the tool was also approved by a Cronbach’s alpha value of 0.90 (
25).
The CSEI was developed and utilized by Coopersmith to gauge general self esteem (
26-
28). It consists of 35 items on a four-point Likert scale (1: strongly agree; 2: agree; 3: disagree; 4: strongly disagree), which yield a total score of 35-140. We categorized self esteem as low, moderate and high (scores: 35-70, 71-105, and 106-140, respectively) in the present study. Moreover, in order to examine the reliability of the questionnaire, it was distributed among 20 drug addicts and completed again by the same population after ten days (test-retest method). Finally, a reliability coefficient of r = 0.85 suggested the CSEI to be acceptably reliable.
The intervention was initiated after the questionnaires had been completed. Both groups received routine care, including weekly meetings with the physician and a minimum of biweekly psychological counseling and social work services, at the facility for two months. The intervention group and their family members also participated in a problem-solving education course, which comprised of eight 45-minute weekly sessions and covered physical, psychological and social-family problems. The education started with sessions to pose the question and continued with data collection, hypotheses formulation and testing, conclusion, and final evaluation, which are the five steps of problem solving-education. In order for the families to reach solutions faster, they were presented with previously prepared handouts. Eight sessions were held and in the first session, the researcher explained the study objectives, and became familiar with families and their points of view. Next, families were divided to three groups of ten for participation in future group discussions.
In the second session, the researcher defined the terms addiction and addict, variety of addictions, causes and roots, common treatments, and problem solving training method in simple words for the study subjects in each group. In this session, problems were identified and classified in three areas of physical, mental, and social-family. The effected family member had to collect information about solutions to the problems, by studying educational notes and using other sources such as radio, TV, the internet, books, etc.
In the third session, study subjects were encouraged to suggest the best and most suitable solutions for the problems of the patients in the physical area, thus they listed the problems faced by their patient.
In the fourth session, study subjects were asked to describe the best and most suitable solutions for their patients’ problems. By the end of the fourth session, the researcher pursued progress of the effected family members in solving physical problems of the patients.
In the fifth session, study subjects were asked to describe the best and most suitable solutions they could think of for their patients’ psychological problems. At the end of the fifth session, the researcher followed up the status of solutions of patient’s psychological problems by the effected family member.
In the sixth session, in addition to following up progress of solving patient’s social-family problems by the effected family member, the researcher also pursued implemented solutions and all the steps taken by this stage, answered the questions raised by the families with assistance of the psychiatrist, social worker and clinic’s psychologist.
In the seventh session, a meeting was held with participation of drug-dependent patients and patients could be familiarized with problem solving techniques and how they should cooperate with their families.
In the eighth and final session, the researcher with cooperation of families, social worker and clinic’s psychologist and using group discussions, followed up patients’ comments from previous sessions, and answered their questions.
Generally, during each session, patients and their family members brainstormed patient problems and various solutions were proposed by patients, families, the researcher, and the facility’s psychologist and social worker. In the meantime, the researcher responded to the participants’ questions via direct contact during training sessions and regular phone calls throughout the course of the study.
Once problem-solving education was complete, both groups filled out the QASEQ and CSEI for a second time. In both groups, drug relapse (slip) was assessed using a morphine test device (ACON, USA), every two weeks, and the results were recorded. The test is commonly implemented as a valid tool in addiction treatment clinics in Iran. The reliability and validity of this particular kit have been previously confirmed, using the test-retest method (r = 0.91) by Habibi et al. (
25).
The collected data was analyzed with the SPSS software for Windows 20.0 (SPSS Inc., Chicago, IL, USA). Paired t-tests were applied to determine intergroup differences between the scores before and after the intervention. Intergroup comparisons between the mean changes of the scores and the frequency of drug relapse were made using Student’s t-test and both chi-square and Fisher’s exact tests, respectively. Logistic regression analysis was performed to identify possible factors affecting relapse, e.g. demographic characteristics (age, gender, marital status, income and education level), the relationship between the patient and his/her family member, type of abused drug, duration of addiction, implementation of the intervention, and mean changes of self efficacy and self esteem scores. Analysis of Covariance (ANCOVA) was carried out to determine factors affecting self esteem and self efficacy scores after the intervention. Also, repeated measure ANOVA analysis was used to evaluate scores within and between groups. Again, the mentioned demographic characteristics, the relationship between the patient and his/her family member, type of abused drug, duration of addiction, implementation of the intervention, and baseline scores of self esteem and self efficacy were included.
3.1. Ethics Committee Approval and Monitoring
This research was completed as part of a graduate student project, code 89392 and under the Research Council of Mashhad University of Medical Sciences and the University Ethics Committee approved the study) number 3142/511 dated Sunday, January 16th, 2011) (10.26.1389 in Shamsi).