Parent Treatment for Child Social Adjustment

NCT ID: NCT01765166

Last Updated: 2013-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-06-30

Brief Summary

This Competing Renewal project continues the research and development of a parent-focused intervention, Parent Guide to SSGRIN, which parallels an established child-focused intervention [Social Skills GRoup INtervention (S.S. GRIN); for children ages 8-12 years], in order to teach and reinforce the same social skills and concepts within the home environment. A primary goal is to address questions of relative impact, longer-term treatment benefits, and differential treatment effects of the Parent Guide training on children's social skill development across settings and populations.

Detailed Description

This Competing Renewal project continues the research and development of a parent-focused intervention, Parent Guide to SSGRIN, which parallels an established child-focused intervention [Social Skills GRoup INtervention (S.S. GRIN); for children ages 8-12 years], in order to teach and reinforce the same social skills and concepts within the home environment. A primary goal of this Competing Renewal is to conduct a rigorous, large-scale, longitudinal research project that is adequately powered to address questions of relative impact, longer-term treatment benefits, and differential treatment effects of the Parent Guide training on children's social skill development across settings and populations. Though schools often struggle with how to increase parent involvement in school-based programs, school officials report that it is infeasible for them to conduct the full series of in-person parent training groups as the Parent Guide's current curriculum demands; therefore, a second goal of this Competing Renewal is to test a Home-study version of the Parent Guide to bridge training into the home environment. The Home-study version of the Parent Guide will be included as a separate treatment condition within the effectiveness trial. This clinical trial will provide S.S.GRIN treatment for 240 children ages 8-12 and vary the level of parent intervention to determine the effectiveness of the two variations of Parent Guide to S.S.GRIN. Parents will be randomly assigned to one of four conditions: (1) Parent Guide treatment; (2) Parent Guide-Home Study treatment; (3) parent attention control; or (4) no treatment. Pre-treatment, post-treatment, 6-month post-treatment, and 12 month post-treatment data will be collected assessing children's social skill development from children, parents, and teachers. Based on past clinical experience, the probability of adverse psychological and behavioral effects from behavioral intervention is very low; however, to ensure participants' safety, a data and safety monitoring plan will be in place.

Conditions

Interpersonal Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parent attention control(PAC)

Children will participate in traditional SSGRIN treatment, and parents will participate in a weekly support group to meet with other parents regarding their child's peer relations and behavior. The support group will meet for a parallel amount of time (1 hour/week for 10 weeks) and be facilitated by two parents with no SSGRIN or Parent Guide experience. The PAC condition will reflect the social support functions of a parenting group, but no therapeutic skills training or other instructional materials will be provided.

Group Type: EXPERIMENTAL

SSGRIN-Parent Guide

Intervention Type: BEHAVIORAL

All children will receive traditional SSGRIN(Social Skills Group Intervention), but parents will vary in the level of parent treatment. Families will be randomly assigned to one of four treatment conditions(approximately 25% each): (a) Traditional SSGRIN child treatment with no parent involvement (ChO), (b) SSGRIN child treatment plus parent attention control (PAC), (c) SSGRIN child treatment plus Parent Guide-Home-study treatment (PG-HS), or (d) SSGRIN child treatment plus traditional Parent Guide treatment (PG).

Parent Guide-Home Study(PG-HS)

Children will receive traditional SSGRIN treatment, and parents will receive the Parent Guide to SSGRIN training by participating in the online Parent Guide Home Study (PG-HS) course. The PG-HS course will include all instructional content and materials for the in-person Parent Guide course, but parent will receive the training online.

Group Type: EXPERIMENTAL

SSGRIN-Parent Guide

Intervention Type: BEHAVIORAL

All children will receive traditional SSGRIN(Social Skills Group Intervention), but parents will vary in the level of parent treatment. Families will be randomly assigned to one of four treatment conditions(approximately 25% each): (a) Traditional SSGRIN child treatment with no parent involvement (ChO), (b) SSGRIN child treatment plus parent attention control (PAC), (c) SSGRIN child treatment plus Parent Guide-Home-study treatment (PG-HS), or (d) SSGRIN child treatment plus traditional Parent Guide treatment (PG).

Parent Guide(PG)

Children will receive traditional SSGRIN treatment and parents will receive parallel traditional in-person SSGRIN-Parent Guide treatment.

Group Type: EXPERIMENTAL

SSGRIN-Parent Guide

Intervention Type: BEHAVIORAL

All children will receive traditional SSGRIN(Social Skills Group Intervention), but parents will vary in the level of parent treatment. Families will be randomly assigned to one of four treatment conditions(approximately 25% each): (a) Traditional SSGRIN child treatment with no parent involvement (ChO), (b) SSGRIN child treatment plus parent attention control (PAC), (c) SSGRIN child treatment plus Parent Guide-Home-study treatment (PG-HS), or (d) SSGRIN child treatment plus traditional Parent Guide treatment (PG).

Control(ChO)

Children receive traditional SSGRIN child treatment with no parent involvement

Group Type: EXPERIMENTAL

SSGRIN-Parent Guide

Intervention Type: BEHAVIORAL

All children will receive traditional SSGRIN(Social Skills Group Intervention), but parents will vary in the level of parent treatment. Families will be randomly assigned to one of four treatment conditions(approximately 25% each): (a) Traditional SSGRIN child treatment with no parent involvement (ChO), (b) SSGRIN child treatment plus parent attention control (PAC), (c) SSGRIN child treatment plus Parent Guide-Home-study treatment (PG-HS), or (d) SSGRIN child treatment plus traditional Parent Guide treatment (PG).

Interventions

SSGRIN-Parent Guide

All children will receive traditional SSGRIN(Social Skills Group Intervention), but parents will vary in the level of parent treatment. Families will be randomly assigned to one of four treatment conditions(approximately 25% each): (a) Traditional SSGRIN child treatment with no parent involvement (ChO), (b) SSGRIN child treatment plus parent attention control (PAC), (c) SSGRIN child treatment plus Parent Guide-Home-study treatment (PG-HS), or (d) SSGRIN child treatment plus traditional Parent Guide treatment (PG).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa E DeRosier, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

3-C Institute for Social Development

Amanda W Harrell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

3-C Institute for Social Development

Allan K Chrisman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

3-C Institute for Social Development

Cary, North Carolina, United States

Duke Child and Family Study Center

Durham, North Carolina, United States

Countries

United States

References

DeRosier ME. Building relationships and combating bullying: effectiveness of a school-based social skills group intervention. J Clin Child Adolesc Psychol. 2004 Mar;33(1):196-201. doi: 10.1207/S15374424JCCP3301_18.

Reference Type: BACKGROUND

PMID: 15028553 (View on PubMed)

DeRosier ME, Marcus SR. Building friendships and combating bullying: effectiveness of S.S.GRIN at one-year follow-up. J Clin Child Adolesc Psychol. 2005 Mar;34(1):140-50. doi: 10.1207/s15374424jccp3401_13.

Reference Type: BACKGROUND

PMID: 15677288 (View on PubMed)

DeRosier, M.E. & Gilliom, M. (2007). Effectiveness of a parent training program for improving children's social behavior. Journal of Child and Family Studies, 16, 660-670.

Reference Type: BACKGROUND

DeRosier, M.E. (1995). Summary of 3-C Program Results with 3rd through 5th graders in the WCPSS.

Reference Type: BACKGROUND

DeRosier, M.E. (2002). Group interventions and exercises for enhancing children's communication,cooperation, and confidence. Sarasota, FL: Professional Resources Press.

Reference Type: BACKGROUND

DeRosier, M.E. (2006). Social Skills Group Intervention - Parent Guide(S.S.GRIN-PG). Cary, NC: SELmedia,Inc.

Reference Type: BACKGROUND

Related Links

http://www.3cisd.com/

3-C ISD website

Other Identifiers

2R44MH065718-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00019396

Identifier Type: -

Identifier Source: org_study_id